At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label, Randomized, Multicenter Study of the Safety, Tolerability, and Immunogenicity of Gardasil (V501) Given Concomitantly With REPEVAX™ in Healthy Adolescents 11-17 Years of Age
In Brief
A Phase 3 clinical trial evaluating Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Current Manufacturing Facility (CMF), Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Future Manufacturing Facility (FMF), and 2 other interventions for Neoplasms, Glandular and Epithelial and 4 related conditions. Completed, enrolled 843 participants.
Detailed Summary
Data from this study are expected to demonstrate that Gardasil (V501, Human Papillomavirus \[Types 6, 11, 16, 18\] Recombinant Vaccine), when administered concomitantly with a combined diphtheria, tetanus, pertussis, and poliomyelitis vaccine in adolescents remains immunogenic and well-tolerated and it does not impair the immunogenicity of the concomitant vaccines.
Study Details
Timeline
Interventions
GARDASIL™ (quadrivalent human papillomavirus \[types 6, 11, 16, 18\] virus-like particle \[VLP\] vaccine, referred to as qHPV vaccine) made at the current manufacturing facility was administered as 0.5-mL intramuscular dose at Day 1, Month 2, and Month 6.
GARDASIL™ (quadrivalent human papillomavirus \[types 6, 11, 16, 18\] virus-like particle \[VLP\] vaccine, referred to as qHPV vaccine) made at the future manufacturing facility was administered as 0.5-mL intramuscular dose at Day 1, Month 2, and Month 6.
REPEVAX™ (diphtheria, tetanus, pertussis \[acellular, component\] and poliomyelitis \[inactivated\] vaccine, Sanofi Pasteur, Swiftwater, PA U.S.A) was administered as a single 0.5-mL intramuscular dose at Day 1 in a limb opposite that of quadrivalent HPV injection.
REPEVAX™ (diphtheria, tetanus, pertussis \[acellular, component\] and poliomyelitis \[inactivated\] vaccine, Sanofi Pasteur, Swiftwater, PA U.S.A) was administered as a single 0.5-mL intramuscular dose at Month 1 in a limb opposite that of quadrivalent HPV injection.