Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:58 PM
Study NCT ID:
NCT00312858
Status:
COMPLETED
Last Update Posted:
2017-04-13
First Post:
2006-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Concomitant Use of Hepatitis A Vaccine With Measles, Mumps, Rubella and Varicella Vaccine and Pneumococcal 7-Valent Conjugate Vaccine in Healthy 12-Month-Old Children (V251-067)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Puerto Rico', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006505', 'term': 'Hepatitis'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D022362', 'term': 'Hepatitis A Vaccines'}, {'id': 'D019433', 'term': 'Chickenpox Vaccine'}, {'id': 'D022242', 'term': 'Pneumococcal Vaccines'}], 'ancestors': [{'id': 'D014761', 'term': 'Viral Hepatitis Vaccines'}, {'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D022283', 'term': 'Herpesvirus Vaccines'}, {'id': 'D022541', 'term': 'Streptococcal Vaccines'}, {'id': 'D001428', 'term': 'Bacterial Vaccines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Arm 1: VAQTA™ + ProQuad™ + Prevnar™', 'description': 'VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.', 'otherNumAffected': 231, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™', 'description': 'VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.', 'otherNumAffected': 172, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Ear Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Otorrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Eye Discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Eye Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Gastroesophageal Reflux Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Oral Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Teething', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Body Temperature', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 126}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 53}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Drug Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Multiple Allergies', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Seasonal Allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Acute Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Adenovirus Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Body Tinea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Candida Nappy Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Conjunctivitis Bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Conjunctivitis Infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Conjunctivitis Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Croup Infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Ear Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Enterobiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Eye Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Gastroenteritis Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Impetigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Mycoplasma Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Otitis Media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Otitis Media Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pharyngitis Streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pharyngotonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Respiratory Syncytial Virus Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Roseola', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Skin Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Tinea Pedis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Viraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Viral Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Viral Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Viral Skin Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Viral upper respiratory tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Arthropod Bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Arthropod Sting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Head Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Lower Limb Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Sunburn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Thermal Burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Decreased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypervitaminosis A', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Iron Deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Muscular Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pain In Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Febrile Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Crying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Sleep Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Penile Discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Bronchial Hyperreactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nasal Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Paranasal Sinus Hypersecretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pharyngolaryngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Respiratory Tract Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Rhinalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Rhinitis Allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Rhinorrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Sinus Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Sneezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dermatitis Allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dermatitis Atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dermatitis Contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dermatitis Diaper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Erythema Multiforme', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Rash Macular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Rash Maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Rash Morbilliform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Rash Rubelliform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Rash Vesicular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Bruising, Injection site for VAQTA™', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Erythema, Injection site for VAQTA™', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 51}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Haemorrhage, Injection site for VAQTA™', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nodule, Injection site for VAQTA™', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pain, Injection site for VAQTA™', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 86}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 73}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Rash, Injection site for VAQTA™', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Reaction, Injection site for VAQTA™', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Swelling, Injection site for VAQTA™', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 38}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Warmth, Injection site for VAQTA™', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 323, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 323, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Perineal Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 323, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Genital Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 323, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 323, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 323, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 323, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Febrile Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 323, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Gastrointestinal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 323, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Antibody Response to Hepatitis A - Participants With a Serological Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: VAQTA™ + ProQuad™ + Prevnar™', 'description': 'VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.'}, {'id': 'OG001', 'title': 'Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™', 'description': 'VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '182', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '3.8', 'pValueComment': 'Similarity (non-inferiority) indicated that the risk difference was statistically significantly greater than the pre-specified clinically relevant difference of -10 percentage points at the 1-sided α=0.025 level.', 'estimateComment': 'Difference in estimated response rates of Arm 1 - Arm 2.', 'groupDescription': 'Comparison of the difference (percentage points) in estimated response rates of Arm 1 - Arm 2.', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'For testing the non-inferiority of 2 proportions. Stratified by investigator.', 'nonInferiorityComment': 'Similarity (non-inferiority) based on lower bound of the 2-sided 95% CI on the risk difference of seroresponse rates excluding a decrease of 10 percentage points or more (lower bound \\>-10.0).'}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™)', 'description': 'Number of participants with titer ≥10 mIU/mL, i.e., seropositive for hepatitis A antibody, regardless of initial serostatus', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol analysis set includes participants who received 2 doses of VAQTA™ (hepatitis A vaccine), had a Postdose 2 serology results, and followed the protocol procedures.'}, {'type': 'PRIMARY', 'title': 'Antibody Response to Varicella - Participants With a Serological Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: VAQTA™ + ProQuad™ + Prevnar™', 'description': 'VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.'}, {'id': 'OG001', 'title': 'Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™', 'description': 'VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.'}], 'classes': [{'title': 'Number of participants ≥1.25 gpELISA units/mL', 'categories': [{'measurements': [{'value': '222', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}]}, {'title': 'Number of participants ≥5 gpELISA units/mL', 'categories': [{'measurements': [{'value': '210', 'groupId': 'OG000'}, {'value': '228', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.013', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciPctValue': '95', 'paramValue': '-5.1', 'ciLowerLimit': '-9.3', 'ciUpperLimit': '-1.4', 'pValueComment': 'Similarity (non-inferiority) indicated that the risk difference was statistically significantly greater than the pre-specified clinically relevant difference of -10 percentage points at the 1-sided multiplicity-adjusted α=0.025 level.', 'estimateComment': 'Difference in estimated response rates of Arm 1 - Arm 2.', 'groupDescription': 'Comparison of the difference (percentage points) in estimated response rates of Arm 1 - Arm 2 for participants with initial serostatus \\<1.25 gpELISA units/mL', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'For testing the non-inferiority of 2 proportions. Stratified by investigator.', 'nonInferiorityComment': 'Similarity (non-inferiority) based on lower bound of the 2-sided 95% CI on the risk difference seroresponse rates excluding a decrease of 10 percentage points or more (lower bound \\>-10.0).'}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks Postdose 1 of varicella-containing vaccine (ProQuad™)', 'description': 'Participants with varicella baseline antibody titer \\<1.25 gpELISA units/mL and Postdose 1 titers ≥1.25 gpELISA units/mL (seroconversion) and ≥5 gpELISA units/mL (seroprotection)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol analysis set includes participants who received the initial dose of ProQuad™ (varicella-containing vaccine), had a Postdose 1 serology result, and followed the protocol procedures.'}, {'type': 'PRIMARY', 'title': 'Antibody Response to Streptococcus Pneumoniae - Geometric Mean Titers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}, {'value': '323', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: VAQTA™ + ProQuad™ + Prevnar™', 'description': 'VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.'}, {'id': 'OG001', 'title': 'Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™', 'description': 'VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.'}], 'classes': [{'title': 'Serotype 4 (n=246, 247)', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '2.1'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.4', 'upperLimit': '1.8'}]}]}, {'title': 'Serotype 6B (n=246, 246)', 'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000', 'lowerLimit': '8.3', 'upperLimit': '11.0'}, {'value': '9.6', 'groupId': 'OG001', 'lowerLimit': '8.5', 'upperLimit': '10.8'}]}]}, {'title': 'Serotype 9V (n=247, 247)', 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000', 'lowerLimit': '3.2', 'upperLimit': '4.2'}, {'value': '4.1', 'groupId': 'OG001', 'lowerLimit': '3.7', 'upperLimit': '4.7'}]}]}, {'title': 'Serotype 14 (n=248, 247)', 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000', 'lowerLimit': '6.8', 'upperLimit': '8.8'}, {'value': '7.4', 'groupId': 'OG001', 'lowerLimit': '6.5', 'upperLimit': '8.4'}]}]}, {'title': 'Serotype 18C (n=247, 247)', 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '2.6', 'upperLimit': '3.3'}, {'value': '2.6', 'groupId': 'OG001', 'lowerLimit': '2.3', 'upperLimit': '3.0'}]}]}, {'title': 'Serotype 19F (n=248, 248)', 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '3.5', 'upperLimit': '4.5'}, {'value': '3.8', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '4.3'}]}]}, {'title': 'Serotype 23F (n=247, 247)', 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000', 'lowerLimit': '4.3', 'upperLimit': '5.6'}, {'value': '4.5', 'groupId': 'OG001', 'lowerLimit': '3.9', 'upperLimit': '5.1'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Response ratio (Arm 1 / Arm 2)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '0.9', 'ciUpperLimit': '1.3', 'estimateComment': 'Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer', 'groupDescription': 'Serotype 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is \\>0.5, excluding a decrease of 2-fold or more'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Response ratio (Arm 1 / Arm 2)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': '0.8', 'ciUpperLimit': '1.2', 'estimateComment': 'Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer', 'groupDescription': 'Serotype 6B', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is \\>0.5, excluding a decrease of 2-fold or more'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Response ratio (Arm 1 / Arm 2)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9', 'ciLowerLimit': '0.8', 'ciUpperLimit': '1.0', 'estimateComment': 'Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer', 'groupDescription': 'Serotype 9V', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is \\>0.5, excluding a decrease of 2-fold or more'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Response ratio (Arm 1 / Arm 2)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': '0.9', 'ciUpperLimit': '1.2', 'estimateComment': 'Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer', 'groupDescription': 'Serotype 14', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is \\>0.5, excluding a decrease of 2-fold or more'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Response ratio (Arm 1 / Arm 2)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '0.9', 'ciUpperLimit': '1.3', 'estimateComment': 'Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer', 'groupDescription': 'Serotype 18C', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is \\>0.5, excluding a decrease of 2-fold or more'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Response ratio (Arm 1 / Arm 2)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '0.9', 'ciUpperLimit': '1.2', 'estimateComment': 'Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer', 'groupDescription': 'Serotype 19F', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is \\>0.5, excluding a decrease of 2-fold or more'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Response ratio (Arm 1 / Arm 2)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '1.0', 'ciUpperLimit': '1.3', 'estimateComment': 'Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer', 'groupDescription': 'Serotype 23F', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is \\>0.5, excluding a decrease of 2-fold or more'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)', 'description': 'Serum antibodies to serotype-specific pneumococcal polysaccharides were determined by enzyme-linked immunosorbent assay', 'unitOfMeasure': 'mcg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures'}, {'type': 'PRIMARY', 'title': 'Participants With 1 or More Systemic Adverse Experience', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: VAQTA™ + ProQuad™ + Prevnar™', 'description': 'VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.'}, {'id': 'OG001', 'title': 'Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™', 'description': 'VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '178', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks post dose 1', 'description': 'Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. They are collected the first 14 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 14) within the 6 week study period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all participants who provided safety follow-up after receipt of Dose 1 of VAQTA™ (hepatitis A vaccine)'}, {'type': 'PRIMARY', 'title': 'Participants With 1 or More Systemic Adverse Experience', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '251', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: VAQTA™ + ProQuad™ + Prevnar™', 'description': 'VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.'}, {'id': 'OG001', 'title': 'Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™', 'description': 'VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks post dose 2', 'description': 'Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. They are collected the first 14 days after receipt of dose 2 of hepatitis A vaccine (VAQTA™) (Days 1 to 14) within the 4 week study period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all participants who provided safety follow-up after receipt of Dose 2 of VAQTA™ (hepatitis A vaccine)'}, {'type': 'PRIMARY', 'title': 'Participants With 1 or More Systemic Adverse Experience.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}, {'value': '286', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: VAQTA™ + ProQuad™ + Prevnar™', 'description': 'VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.'}, {'id': 'OG001', 'title': 'Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™', 'description': 'VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '204', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. Collected the first 14 days after each of the 2 doses of hepatitis A vaccine (VAQTA™) (Days 1 to 14), given 6 months apart', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all participants who provided safety follow-up after receipt of any dose of VAQTA™ (hepatitis A vaccine)'}, {'type': 'PRIMARY', 'title': 'Participants With 1 or More Injection-site Adverse Experience', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: VAQTA™ + ProQuad™ + Prevnar™', 'description': 'VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.'}, {'id': 'OG001', 'title': 'Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™', 'description': 'VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks post dose 1', 'description': 'Injection-site adverse experiences collected the first 5 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 6 week study period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all participants who provided safety follow-up after receipt of Dose 1 of VAQTA™ (hepatitis A vaccine)'}, {'type': 'PRIMARY', 'title': 'Participants With 1 or More Injection-site Adverse Experience', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '251', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: VAQTA™ + ProQuad™ + Prevnar™', 'description': 'VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.'}, {'id': 'OG001', 'title': 'Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™', 'description': 'VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks post dose 2', 'description': 'Injection-site adverse experiences collected the first 5 days after receipt of dose 2 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 4 week study period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all participants who provided safety follow-up after receipt of Dose 2 of VAQTA™ (hepatitis A vaccine)'}, {'type': 'PRIMARY', 'title': 'Participants With 1 or More Injection-site Adverse Experience', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}, {'value': '286', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: VAQTA™ + ProQuad™ + Prevnar™', 'description': 'VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.'}, {'id': 'OG001', 'title': 'Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™', 'description': 'VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Injection-site adverse experiences collected the first 5 days after receipt of each dose of hepatitis A vaccine (VAQTA™) (Days 1 to 5) over the 6 months in which the 2 doses of vaccine were administered.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all participants who provided safety follow-up after receipt of any dose of VAQTA™ (hepatitis A vaccine)'}, {'type': 'PRIMARY', 'title': 'Participants With Elevated Temperature (≥102.2F/ ≥39.0C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: VAQTA™ + ProQuad™ + Prevnar™', 'description': 'VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.'}, {'id': 'OG001', 'title': 'Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™', 'description': 'VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks post dose 1', 'description': 'Elevated temperatures measured the first 5 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 6 week study period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all participants who provided safety follow-up after receipt of Dose 1 of VAQTA™ (hepatitis A vaccine)'}, {'type': 'PRIMARY', 'title': 'Participants With Elevated Temperature (≥102.2F/ ≥39.0C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: VAQTA™ + ProQuad™ + Prevnar™', 'description': 'VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.'}, {'id': 'OG001', 'title': 'Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™', 'description': 'VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks post dose 2', 'description': 'Elevated temperatures measured the first 5 days after receipt of dose 2 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 4 week study period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all participants who provided safety follow-up after receipt of Dose 2 of VAQTA™ (hepatitis A vaccine)'}, {'type': 'PRIMARY', 'title': 'Participants With Elevated Temperature (≥102.2F/ ≥39.0C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '293', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: VAQTA™ + ProQuad™ + Prevnar™', 'description': 'VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.'}, {'id': 'OG001', 'title': 'Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™', 'description': 'VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Elevated temperatures measured the first 5 days after receipt of each dose of hepatitis A vaccine (VAQTA™) (Days 1 to 5) over the 6 months in which the 2 doses of vaccine were administered.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all participants who provided safety follow-up after receipt of any dose of VAQTA™ (hepatitis A vaccine)'}, {'type': 'PRIMARY', 'title': 'Participants With 1 or More Serious Vaccine-related Adverse Experience', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: VAQTA™ + ProQuad™ + Prevnar™', 'description': 'VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.'}, {'id': 'OG001', 'title': 'Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™', 'description': 'VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks post dose 1', 'description': 'Serious vaccine-related adverse experience causes death, persistent or significant disability, causes or prolong a hospital stay, is a cancer, an overdose, or life-threatening. 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Pneumoniae Serotype 4 - Participants With a Serological Response', 'timeFrame': '6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)', 'description': 'Number of participants with a postvaccination titer \\>=0.2 mcg/mL for S. pneumoniae serotype 4'}, {'measure': 'Antibody Response to S. Pneumoniae Serotype 6B - Participants With a Serological Response', 'timeFrame': '6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)', 'description': 'Number of participants with a postvaccination titer \\>=0.2 mcg/mL for S. pneumoniae serotype 6B'}, {'measure': 'Antibody Response to S. Pneumoniae Serotype 9V - Participants With a Serological Response', 'timeFrame': '6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)', 'description': 'Number of participants with a postvaccination titer \\>=0.2 mcg/mL for S. pneumoniae serotype 9V'}, {'measure': 'Antibody Response to S. Pneumoniae Serotype 14 - Participants With a Serological Response', 'timeFrame': '6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)', 'description': 'Number of participants with a postvaccination titer \\>=0.2 mcg/mL for S. pneumoniae serotype 14'}, {'measure': 'Antibody Response to S. Pneumoniae Serotype 18C - Participants With a Serological Response', 'timeFrame': '6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)', 'description': 'Number of participants with a postvaccination titer \\>=0.2 mcg/mL for S. pneumoniae serotype 18C'}, {'measure': 'Antibody Response to S. Pneumoniae Serotype 19F - Participants With a Serological Response', 'timeFrame': '6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)', 'description': 'Number of participants with a postvaccination titer \\>=0.2 mcg/mL for S. pneumoniae serotype 19F'}, {'measure': 'Antibody Response to S. Pneumoniae Serotype 23F - Participants With a Serological Response', 'timeFrame': '6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)', 'description': 'Number of participants with a postvaccination titer \\>=0.2 mcg/mL for S. pneumoniae serotype 23F'}], 'primaryOutcomes': [{'measure': 'Antibody Response to Hepatitis A - Participants With a Serological Response', 'timeFrame': '4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™)', 'description': 'Number of participants with titer ≥10 mIU/mL, i.e., seropositive for hepatitis A antibody, regardless of initial serostatus'}, {'measure': 'Antibody Response to Varicella - Participants With a Serological Response', 'timeFrame': '6 weeks Postdose 1 of varicella-containing vaccine (ProQuad™)', 'description': 'Participants with varicella baseline antibody titer \\<1.25 gpELISA units/mL and Postdose 1 titers ≥1.25 gpELISA units/mL (seroconversion) and ≥5 gpELISA units/mL (seroprotection)'}, {'measure': 'Antibody Response to Streptococcus Pneumoniae - Geometric Mean Titers', 'timeFrame': '6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)', 'description': 'Serum antibodies to serotype-specific pneumococcal polysaccharides were determined by enzyme-linked immunosorbent assay'}, {'measure': 'Participants With 1 or More Systemic Adverse Experience', 'timeFrame': '6 weeks post dose 1', 'description': 'Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. They are collected the first 14 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 14) within the 6 week study period.'}, {'measure': 'Participants With 1 or More Systemic Adverse Experience', 'timeFrame': '4 weeks post dose 2', 'description': 'Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. They are collected the first 14 days after receipt of dose 2 of hepatitis A vaccine (VAQTA™) (Days 1 to 14) within the 4 week study period.'}, {'measure': 'Participants With 1 or More Systemic Adverse Experience.', 'timeFrame': '6 months', 'description': 'Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. Collected the first 14 days after each of the 2 doses of hepatitis A vaccine (VAQTA™) (Days 1 to 14), given 6 months apart'}, {'measure': 'Participants With 1 or More Injection-site Adverse Experience', 'timeFrame': '6 weeks post dose 1', 'description': 'Injection-site adverse experiences collected the first 5 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 6 week study period.'}, {'measure': 'Participants With 1 or More Injection-site Adverse Experience', 'timeFrame': '4 weeks post dose 2', 'description': 'Injection-site adverse experiences collected the first 5 days after receipt of dose 2 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 4 week study period.'}, {'measure': 'Participants With 1 or More Injection-site Adverse Experience', 'timeFrame': '6 months', 'description': 'Injection-site adverse experiences collected the first 5 days after receipt of each dose of hepatitis A vaccine (VAQTA™) (Days 1 to 5) over the 6 months in which the 2 doses of vaccine were administered.'}, {'measure': 'Participants With Elevated Temperature (≥102.2F/ ≥39.0C)', 'timeFrame': '6 weeks post dose 1', 'description': 'Elevated temperatures measured the first 5 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 6 week study period.'}, {'measure': 'Participants With Elevated Temperature (≥102.2F/ ≥39.0C)', 'timeFrame': '4 weeks post dose 2', 'description': 'Elevated temperatures measured the first 5 days after receipt of dose 2 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 4 week study period.'}, {'measure': 'Participants With Elevated Temperature (≥102.2F/ ≥39.0C)', 'timeFrame': '6 months', 'description': 'Elevated temperatures measured the first 5 days after receipt of each dose of hepatitis A vaccine (VAQTA™) (Days 1 to 5) over the 6 months in which the 2 doses of vaccine were administered.'}, {'measure': 'Participants With 1 or More Serious Vaccine-related Adverse Experience', 'timeFrame': '6 weeks post dose 1', 'description': 'Serious vaccine-related adverse experience causes death, persistent or significant disability, causes or prolong a hospital stay, is a cancer, an overdose, or life-threatening. They were collected during the entire study and believed due to study vaccine'}, {'measure': 'Participants With 1 or More Serious Vaccine-related Adverse Experience', 'timeFrame': '4 weeks post dose 2', 'description': 'Serious vaccine-related adverse experience causes death, persistent or significant disability, causes or prolong a hospital stay, is a cancer, an overdose, or life-threatening. They were collected during the entire study and believed due to study vaccine'}, {'measure': 'Participants With 1 or More Serious Vaccine-related Adverse Experience', 'timeFrame': '6 months', 'description': 'Serious vaccine-related adverse experience causes death, persistent or significant disability, causes or prolong a hospital stay, is a cancer, an overdose, or life-threatening. They were collected during the entire study and believed due to study vaccine'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hepatitis A Virus'], 'conditions': ['Hepatitis A Virus']}, 'referencesModule': {'references': [{'pmid': '23744509', 'type': 'DERIVED', 'citation': 'Yetman RJ, Shepard JS, Duke A, Stek JE, Petrecz M, Klopfer SO, Kuter BJ, Schodel FP, Lee AW. Concomitant administration of hepatitis A vaccine with measles/mumps/rubella/varicella and pneumococcal vaccines in healthy 12- to 23-month-old children. Hum Vaccin Immunother. 2013 Aug;9(8):1691-7. doi: 10.4161/hv.24873. Epub 2013 Jun 6.'}]}, 'descriptionModule': {'briefSummary': 'Hepatitis A vaccine will be given either alone or together with measles, mumps, rubella, and varicella vaccine and pneumococcal 7-valent conjugate vaccine at the first dose and together with measles, mumps, rubella, and varicella \\[Oka/Merck\\] virus vaccine at the second dose. Immunogenicity and safety data will be collected after each dose of vaccine.', 'detailedDescription': 'Vaccines: V251, Hepatitis A Vaccine, Inactivated (VAQTA™) administered with Measles, Mumps, Rubella and Varicella Vaccine (ProQuad™) and Pneumococcal 7-Valent Conjugate Vaccine (Prevnar™) will have a Duration of Treatment: 2 Doses, 6 months apart.\n\nVaccine: Hepatitis A Vaccine, Inactivated (VAQTA™), administered alone will have a Duration of Treatment: 2 Doses, 6 months apart.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Months', 'minimumAge': '12 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 12- to 15-month-old males and females with no active liver disease\n* A negative history of hepatitis A, measles, mumps, rubella, chickenpox, and/or zoster\n\nExclusion Criteria:\n\n* Males and females previously vaccinated with hepatitis A, measles, mumps, rubella, and/or chickenpox vaccine\n* Any immune deficiency\n* History of allergy to any of the vaccine components\n* History of any seizure disorder'}, 'identificationModule': {'nctId': 'NCT00312858', 'briefTitle': 'Concomitant Use of Hepatitis A Vaccine With Measles, Mumps, Rubella and Varicella Vaccine and Pneumococcal 7-Valent Conjugate Vaccine in Healthy 12-Month-Old Children (V251-067)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'An Open, Randomized, Multicenter Study of the Safety, Tolerability, & Immunogenicity of VAQTA™ Given Concomitantly With PROQUAD™ and PREVNAR™ in Healthy Children 12 Months of Age', 'orgStudyIdInfo': {'id': 'V251-067'}, 'secondaryIdInfos': [{'id': '2005_075'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Arm 1: VAQTA™ 0.5 mL injection (2 doses 6 months apart), ProQuad™ 0.5 mL injection (2 doses 6 months apart), Prevnar™ 0.5 mL injection (one dose), all vaccines administered concomitantly. 28 weeks of study duration.', 'interventionNames': ['Biological: Comparator: VAQTA™ (Hepatitis A vaccine)', 'Biological: Comparator: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine)', 'Biological: Comparator: Prevnar™ (Pneumococcal 7-Valent Conjugate vaccine)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Arm 2: ProQuad™ 0.5 mL injection (2 doses \\~8 months apart), Prevnar™ 0.5 mL injection (one dose), both administered concomitantly, VAQTA™ 0.5 mL injection (2 doses 6 months apart) administered alone. 34 weeks of study duration.', 'interventionNames': ['Biological: Comparator: VAQTA™ (Hepatitis A vaccine)', 'Biological: Comparator: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine)', 'Biological: Comparator: Prevnar™ (Pneumococcal 7-Valent Conjugate vaccine)']}], 'interventions': [{'name': 'Comparator: VAQTA™ (Hepatitis A vaccine)', 'type': 'BIOLOGICAL', 'description': 'VAQTA™ 0.5 mL injection', 'armGroupLabels': ['1', '2']}, {'name': 'Comparator: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine)', 'type': 'BIOLOGICAL', 'description': 'ProQuad™ 0.5 mL injection', 'armGroupLabels': ['1', '2']}, {'name': 'Comparator: Prevnar™ (Pneumococcal 7-Valent Conjugate vaccine)', 'type': 'BIOLOGICAL', 'description': 'Prevnar™ 0.5 mL injection', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\\_Updated%20July\\_9\\_2014.pdf\n\nhttp://engagezone.msd.com/ds\\_documentation.php'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}