Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2025-12-31 @ 10:06 AM
Study NCT ID:
NCT01917357
Status:
COMPLETED
Last Update Posted:
2014-07-15
First Post:
2013-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison of the Immunogenicity and Safety of Quinvaxem in Mono-dose Vials and Uniject
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004165', 'term': 'Diphtheria'}, {'id': 'D014917', 'term': 'Whooping Cough'}, {'id': 'D013742', 'term': 'Tetanus'}, {'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D006192', 'term': 'Haemophilus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}], 'ancestors': [{'id': 'D003354', 'term': 'Corynebacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001885', 'term': 'Bordetella Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D003015', 'term': 'Clostridium Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D016871', 'term': 'Pasteurellaceae Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-12', 'studyFirstSubmitDate': '2013-08-05', 'studyFirstSubmitQcDate': '2013-08-05', 'lastUpdatePostDateStruct': {'date': '2014-07-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Seroprotection Rate: Anti-PRP Antibodies', 'timeFrame': '1 month after the third vaccination'}, {'measure': 'Seroprotection Rate: Anti-hepatitis B Surface Antibodies', 'timeFrame': '1 month after the third vaccination'}, {'measure': 'Anti-diphtheria Toxoid Antibodies', 'timeFrame': '1 month after the third vaccination'}, {'measure': 'Seroprotection Rate: Anti-tetanus Toxoid Antibodies', 'timeFrame': '1 month after the third vaccination'}, {'measure': 'Seroprotection Rate: Anti-B. Pertussis Antibodies', 'timeFrame': '1 month after the third vaccination'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Vaccination', 'Immunisation', 'Virus', 'Diphtheria', 'Pertussis', 'Tetanus', 'Hepatitis B', 'Haemophilus Influenzae', 'Immunity'], 'conditions': ['Diphtheria', 'Pertussis', 'Tetanus', 'Hepatitis B', 'Haemophilus Infections']}, 'descriptionModule': {'briefSummary': 'This is a study to show that vaccination with three doses of Quinvaxem presented in Uniject is not inferior to vaccination with three doses of Quinvaxem presented in single dose vials, with respect to protection against all antibodies (anti-hepatitis B surface antibodies, anti-polyribosyl ribitol phosphate (PRP), anti-diphtheria, anti-tetanus and anti-Bordetella pertussis) one (1) month after completion of the 6-10-14 week vaccination course.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '64 Days', 'minimumAge': '42 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A male or female between, and including, 42 and 64 days of age at the time of the first vaccination\n* Written informed consent obtained from parents/legal guardians of the subject\n* Free of obvious health problems as established by medical history and/or clinical examination before entering the study\n* HepB vaccination at birth (within 48 hours)\n* Available for all scheduled study visits\n\nExclusion Criteria:\n\n* Use of any investigational drug or any investigational vaccine in the 30 days preceding the first dose of study vaccine, or their planned use during the study period and safety follow-up\n* Planned administration of a vaccine not foreseen by the Study Protocol\n* Known or suspected impairment of immune function, known HIV-positivity; actively receiving immunosuppressive therapy, or in receipt of systemic immunosuppressive therapy in the one month prior to study entry (note: inhaled and topical steroids are allowed)\n* Administration of parenteral immunoglobulin preparation and/or blood products since birth\n* Previous vaccination against Hib and/or DTP\n* History of anaphylaxis, or any serious vaccine reaction, or hypersensitivity to any vaccine component or to products containing mercury compounds, such as thiomersal\n* Clinically significant acute infection\n* Clinically significant acute illness\n* Any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives\n* Participation in another clinical study'}, 'identificationModule': {'nctId': 'NCT01917357', 'briefTitle': 'A Comparison of the Immunogenicity and Safety of Quinvaxem in Mono-dose Vials and Uniject', 'organization': {'class': 'INDUSTRY', 'fullName': 'Crucell Holland BV'}, 'officialTitle': 'A Phase III, Open-label, Randomized Parallel-group Study on the Immunogenicity and Safety of Quinvaxem® DTwP-HepB-Hib) in Uniject™ With Quinvaxem® Monodose Vials in Healthy Infants at 6, 10 and 14 Weeks of Age', 'orgStudyIdInfo': {'id': 'QVX-V-D001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Quinvaxem in Uniject', 'description': 'A single dose (0.5 mL) of Quinvaxem contains:\n\ndiphtheria antitoxin (\\>= 30 IU), tetanus antitoxin (\\>= 60 IU), whole-cell inactive pertussis bacteria (\\>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen\n\nOne dose of Quinvaxem given intramuscularly at Weeks 6, 10 and 14 by injection into the anterolateral region of the thigh using the Uniject pre-filled injection device', 'interventionNames': ['Biological: Quinvaxem in Uniject']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Quinvaxem in single dose vials', 'description': 'A single dose (0.5 mL) of Quinvaxem contains:\n\ndiphtheria antitoxin (\\>= 30 IU), tetanus antitoxin (\\>= 60 IU), whole-cell inactive pertussis bacteria (\\>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen\n\nOne dose of Quinvaxem given intramuscularly at Weeks 6, 10 and 14 by injection into the anterolateral region of the thigh using a needle and syringe from single dose vials', 'interventionNames': ['Biological: Quinvaxem in single dose vials']}], 'interventions': [{'name': 'Quinvaxem in Uniject', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Quinvaxem in Uniject']}, {'name': 'Quinvaxem in single dose vials', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Quinvaxem in single dose vials']}]}, 'contactsLocationsModule': {'locations': [{'city': 'City of Muntinlupa', 'country': 'Philippines', 'facility': 'Research Institute for Tropical Medicine', 'geoPoint': {'lat': 14.39028, 'lon': 121.0475}}], 'overallOfficials': [{'name': 'Maria RZ Capeding, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research Institute for Tropical Medicine (RITM)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Crucell Holland BV', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}