Phase 3
N=110
Safety, Tolerability and Immunogenicity of HPV (Human Papilloma Virus) Vaccine in Healthy Females 9 to 15 Years of Age in India (V501-029)
Papillomavirus Infections
Bottom Line
View on ClinicalTrials.gov: NCT00380367 ↗Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Apr 2009
Primary outcome: Primary: Percentage of Participants Who Seroconvert to Each HPV Serotype (Types 6, 11, 16, 18) at Month 7 — 96.97; 99.05; 99.05; 99.05 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (Biological)
- Age
- Pediatric · 9+ yrs
- Sex
- Female
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Feb 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Seroconvert to Each HPV Serotype (Types 6, 11, 16, 18) at Month 7 |
96.97; 99.05; 99.05; 99.05 | — |
| PRIMARY Number of Participants With Any Adverse Events (AEs), Injection-site AEs, Systemic AEs, or Vaccine-related AEs During the Study |
63; 50; 35; 45 | — |
Summary
The purpose of this study is to evaluate the safety and tolerability of the Quadrivalent Human Papilloma Virus (HPV) vaccine in healthy females 9 to 15 years of age in India. Quadrivalent HPV Vaccine is composed of L1 virus-like particles (VLPs) from HPV types 6, 11, 16, and 18.
Eligibility Criteria
Inclusion Criteria
- Healthy Females Age 9 To 15 Years
- Females Not Sexually Active And Not Plan On Becoming Sexually Active During The Study
- No Fevers 24 Hours Prior To The First Injection
Exclusion Criteria
- Participant Had Received A Prior Vaccination With A HPV Vaccine
- Participant Has Allergies To Vaccine Component Including Aluminum And Yeast
- Participant Has (Human Immunodeficiency Virus) HIV Infection
- Participant Is Immunocompromised
- Participant Received Or Plans To Receive Blood-Derived Product Within 6 Months Prior To The First Injection
- Participant Received Or Plans To Receive Immune Globulin Preparation Within 6 Months To The First Injection
Data sourced from ClinicalTrials.gov (NCT00380367). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.