Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-06-23 @ 12:00 PM
Study NCT ID:
NCT02062502
Status:
COMPLETED
Last Update Posted:
2018-10-30
First Post:
2014-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Immunogenicity and Safety of VARIVAX™ New Seed Process (NSP) in Children (V210-063)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D002644', 'term': 'Chickenpox'}], 'ancestors': [{'id': 'D000073618', 'term': 'Varicella Zoster Virus Infection'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D022542', 'term': 'Measles-Mumps-Rubella Vaccine'}], 'ancestors': [{'id': 'D017778', 'term': 'Vaccines, Combined'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D008458', 'term': 'Measles Vaccine'}, {'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D009108', 'term': 'Mumps Vaccine'}, {'id': 'D012411', 'term': 'Rubella Vaccine'}]}}, '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': 'The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2', 'description': 'The at-risk safety population is All Subjects as Treated with safety results.', 'eventGroups': [{'id': 'EG000', 'title': 'VARIVAX™ New Seed Process + M-M-R II™', 'description': 'VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.', 'otherNumAtRisk': 291, 'otherNumAffected': 225, 'seriousNumAtRisk': 291, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'VARIVAX™ 2007 Process + M-M-R II™', 'description': 'VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.', 'otherNumAtRisk': 293, 'otherNumAffected': 224, 'seriousNumAtRisk': 293, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numEvents': 42, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 25, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numEvents': 34, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 21, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numEvents': 181, 'numAffected': 95}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 190, 'numAffected': 94}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numEvents': 272, 'numAffected': 106}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 270, 'numAffected': 117}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numEvents': 110, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 96, 'numAffected': 59}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numEvents': 86, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 87, 'numAffected': 60}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numEvents': 38, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 36, 'numAffected': 33}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Otitis media acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numEvents': 24, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 16, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numEvents': 59, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 51, 'numAffected': 44}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Viral rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 18, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 18, 'numAffected': 13}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 29, 'numAffected': 25}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 18, 'numAffected': 17}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numEvents': 37, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 35, 'numAffected': 26}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Dermatitis diaper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numEvents': 28, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 30, 'numAffected': 27}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numEvents': 27, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}], 'seriousEvents': [{'term': 'Drowning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Groin abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Lobar pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Otitis media acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Respiratory syncytial virus bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Status asthmaticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'VARIVAX™ New Seed Process + M-M-R II™', 'description': 'VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.'}, {'id': 'OG001', 'title': 'VARIVAX™ 2007 Process + M-M-R II™', 'description': 'VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.'}], 'classes': [{'categories': [{'measurements': [{'value': '97.2', 'groupId': 'OG000'}, {'value': '97.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-3.2', 'ciUpperLimit': '3.2', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'The conclusion of non-inferiority (similarity) is based on the lower bound of the 2-sided 95% CI on the risk difference excluding a decrease equal to or more than the prespecified criterion of 10.0 percentage points for Varicella zoster virus.'}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks (43 days) after vaccination 1', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population is participants with a seronegative antibody titer at baseline and postvaccination serology contributing to the per-protocol analysis.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titer of VZV Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'VARIVAX™ New Seed Process + M-M-R II™', 'description': 'VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.'}, {'id': 'OG001', 'title': 'VARIVAX™ 2007 Process + M-M-R II™', 'description': 'VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.28', 'groupId': 'OG000', 'lowerLimit': '15.11', 'upperLimit': '17.55'}, {'value': '17.2', 'groupId': 'OG001', 'lowerLimit': '15.86', 'upperLimit': '18.65'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.95', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.06', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'The conclusion of non-inferiority (similarity) is based on the lower bound of the 2-sided 95% CI on fold-difference, excluding a decrease of 1.5 fold or more.'}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'Antibody Response Rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '97.2', 'ciLowerLimit': '94.4', 'ciUpperLimit': '98.9', 'groupDescription': 'The conclusion of acceptability is based on the lower bound of the 95% Confidence Interval (CI) being \\>76%, and implies that the value of the parameter is statistically significantly greater than the prespecified acceptability criterion (76%).', 'statisticalMethod': 'Exact CI method/binomial proportion', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '6 weeks (43 days) after vaccination 1', 'description': 'Antibody titers were measured with gpELISA.', 'unitOfMeasure': 'gpELISA units/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population is participants with seronegative antibody titer at baseline and postvaccination serology contributing to the per-protocol analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Fever (>=102.2 °F Oral Equivalent)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'VARIVAX™ New Seed Process + M-M-R II™', 'description': 'VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.'}, {'id': 'OG001', 'title': 'VARIVAX™ 2007 Process + M-M-R II™', 'description': 'VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.'}], 'classes': [{'title': 'Up to 42 days after Vaccination 1: n=285, 287', 'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000'}, {'value': '10.5', 'groupId': 'OG001'}]}]}, {'title': 'Up to 42 days after Vaccination 2: n=258, 267', 'categories': [{'measurements': [{'value': '8.1', 'groupId': 'OG000'}, {'value': '8.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 42 days after Vaccination 1 and Vaccination 2 (up to 133 days)', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population is All Subjects as Treated with temperature data at the time of assessment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'VARIVAX™ New Seed Process + M-M-R II™', 'description': 'VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.'}, {'id': 'OG001', 'title': 'VARIVAX™ 2007 Process + M-M-R II™', 'description': 'VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.'}], 'classes': [{'title': 'Measles-like Rash', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}, {'value': '2.4', 'groupId': 'OG001'}]}]}, {'title': 'Rubella-like Rash', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Varicella-like Rash', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'Mumps-like Symptoms', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Injection-site Rash', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}, {'value': '1.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 42 days after Vaccination 1', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population is All Subjects as Treated with results after Vaccination 1.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '276', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'VARIVAX™ New Seed Process + M-M-R II™', 'description': 'VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.'}, {'id': 'OG001', 'title': 'VARIVAX™ 2007 Process + M-M-R II™', 'description': 'VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.'}], 'classes': [{'title': 'Measles-like Rash', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Rubella-like Rash', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Varicella-like Rash', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Mumps-like Symptoms', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Injection-site Rash', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 42 days after Vaccination 2', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population is All Subjects as Treated with results after vaccination 2'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'VARIVAX™ New Seed Process + M-M-R II™', 'description': 'VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.'}, {'id': 'OG001', 'title': 'VARIVAX™ 2007 Process + M-M-R II™', 'description': 'VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.'}], 'classes': [{'title': 'Injection-site Erythema', 'categories': [{'measurements': [{'value': '20.3', 'groupId': 'OG000'}, {'value': '19.8', 'groupId': 'OG001'}]}]}, {'title': 'Injection-site Swelling', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000'}, {'value': '10.6', 'groupId': 'OG001'}]}]}, {'title': 'Injection-site Pain/Tenderness', 'categories': [{'measurements': [{'value': '29.9', 'groupId': 'OG000'}, {'value': '28.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 days after Vaccination 1', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population is All Subjects as Treated with results after Vaccination 1.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '276', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'VARIVAX™ New Seed Process + M-M-R II™', 'description': 'VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.'}, {'id': 'OG001', 'title': 'VARIVAX™ 2007 Process + M-M-R II™', 'description': 'VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.'}], 'classes': [{'title': 'Injection-site Erythema', 'categories': [{'measurements': [{'value': '20.6', 'groupId': 'OG000'}, {'value': '22.5', 'groupId': 'OG001'}]}]}, {'title': 'Injection-site Swelling', 'categories': [{'measurements': [{'value': '16.2', 'groupId': 'OG000'}, {'value': '12.0', 'groupId': 'OG001'}]}]}, {'title': 'Injection-site Pain/Tenderness', 'categories': [{'measurements': [{'value': '22.4', 'groupId': 'OG000'}, {'value': '24.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 days after Vaccination 2', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population is All Subjects as Treated with results after vaccination 2.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'VARIVAX™ New Seed Process + M-M-R II™', 'description': 'VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.'}, {'id': 'FG001', 'title': 'VARIVAX™ 2007 Process + M-M-R II™', 'description': 'VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '306'}, {'groupId': 'FG001', 'numSubjects': '305'}]}, {'type': 'Vaccinated Dose 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '306'}, {'groupId': 'FG001', 'numSubjects': '305'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '263'}, {'groupId': 'FG001', 'numSubjects': '270'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '35'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'BG000'}, {'value': '305', 'groupId': 'BG001'}, {'value': '611', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'VARIVAX™ New Seed Process + M-M-R II™', 'description': 'VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.'}, {'id': 'BG001', 'title': 'VARIVAX™ 2007 Process + M-M-R II™', 'description': 'VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '12.9', 'spread': '1.9', 'groupId': 'BG000'}, {'value': '12.8', 'spread': '1.7', 'groupId': 'BG001'}, {'value': '12.9', 'spread': '1.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '140', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '279', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '166', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '332', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All randomized participants'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 611}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2015-10-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-01', 'studyFirstSubmitDate': '2014-02-12', 'resultsFirstSubmitDate': '2016-02-02', 'studyFirstSubmitQcDate': '2014-02-12', 'lastUpdatePostDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-02-02', 'studyFirstPostDateStruct': {'date': '2014-02-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-03-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL', 'timeFrame': '6 weeks (43 days) after vaccination 1'}, {'measure': 'Geometric Mean Titer of VZV Antibodies', 'timeFrame': '6 weeks (43 days) after vaccination 1', 'description': 'Antibody titers were measured with gpELISA.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Fever (>=102.2 °F Oral Equivalent)', 'timeFrame': 'Up to 42 days after Vaccination 1 and Vaccination 2 (up to 133 days)'}, {'measure': 'Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 1', 'timeFrame': 'Up to 42 days after Vaccination 1'}, {'measure': 'Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 2', 'timeFrame': 'Up to 42 days after Vaccination 2'}, {'measure': 'Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 1', 'timeFrame': 'Up to 5 days after Vaccination 1'}, {'measure': 'Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 2', 'timeFrame': 'Up to 5 days after Vaccination 2'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Varicella']}, 'referencesModule': {'references': [{'pmid': '29087781', 'type': 'RESULT', 'citation': 'Senders SD, Bundick ND, Li J, Zecca C, Helmond FA. Evaluation of immunogenicity and safety of VARIVAX New Seed Process (NSP) in children. Hum Vaccin Immunother. 2018 Feb 1;14(2):442-449. doi: 10.1080/21645515.2017.1388479. Epub 2017 Dec 11.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the immunogenicity, safety, and tolerability of VARIVAX™ (Varicella Virus Vaccine Live) manufactured with a New Seed Process (NSP) compared with the VARIVAX™ 2007 process. The primary hypotheses being tested are that antibody response rate and mean antibody titer induced at 6 weeks after a single vaccination by VARIVAX™ NSP are non-inferior to those induced by VARIVAX™ 2007 process, and that antibody response rate induced by VARIVAX™ NSP is acceptable.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '23 Months', 'minimumAge': '12 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Negative clinical history for varicella, herpes zoster, measles, mumps, and rubella\n\nExclusion Criteria:\n\n* Received any measles, mumps, rubella, or varicella vaccine at any time prior to the study, or is anticipated to receive any of these vaccines outside the study\n* Any congenital or acquired immune deficiency, neoplastic disease, or depressed immunity\n* Received systemic immunomodulatory steroids within 3 months prior to entering the study or is expected to receive them during the course of the study\n* History of allergy or anaphylactic reaction to neomycin, gelatin, sorbitol, egg proteins, chicken proteins, or any component of VARIVAX™ or M-M-R II™\n* Received salicylates within 14 days prior to study vaccination\n* Exposed to varicella, herpes zoster, measles, mumps, or rubella in the 4 weeks prior to study vaccination\n* Received immune globulin, a blood transfusion, or blood-derived products within 5 months prior to study vaccination\n* History of seizure disorder, including febrile seizure\n* Fever illness (\\>=102.2 °F \\[39.0 °C\\] within 72 hours prior to study vaccination\n* History of thrombocytopenia\n* Born to a human immunodeficiency virus (HIV)-infected mother\n* Participated in any other clinical trial (other than a surveillance study) within 30 days prior to study enrollment.'}, 'identificationModule': {'nctId': 'NCT02062502', 'briefTitle': 'Evaluation of Immunogenicity and Safety of VARIVAX™ New Seed Process (NSP) in Children (V210-063)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase III Double Blind, Randomized, Multicenter, Controlled Study to Evaluate the Immunogenicity, Safety, and Tolerability of VARIVAX™ New Seed Process (NSP) Administered Concomitantly With M-M-R™ II', 'orgStudyIdInfo': {'id': 'V210-063'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VARIVAX™ NSP + M-M-R II™', 'description': 'VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91', 'interventionNames': ['Biological: VARIVAX™ New Seed Process', 'Biological: M-M-R II™']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'VARIVAX™ 2007 Process + M-M-R II™', 'description': 'VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91', 'interventionNames': ['Biological: VARIVAX™ 2007 process', 'Biological: M-M-R II™']}], 'interventions': [{'name': 'VARIVAX™ New Seed Process', 'type': 'BIOLOGICAL', 'description': 'Varicella virus vaccine live manufactured with a new seed process', 'armGroupLabels': ['VARIVAX™ NSP + M-M-R II™']}, {'name': 'VARIVAX™ 2007 process', 'type': 'BIOLOGICAL', 'description': 'Varicella virus vaccine live manufactured with the 2007 process', 'armGroupLabels': ['VARIVAX™ 2007 Process + M-M-R II™']}, {'name': 'M-M-R II™', 'type': 'BIOLOGICAL', 'description': 'Measles, Mumps, and Rubella virus vaccine live', 'armGroupLabels': ['VARIVAX™ 2007 Process + M-M-R II™', 'VARIVAX™ NSP + M-M-R II™']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}