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NCT01245764

GARDASIL™ Study in Healthy Females Between 9 and 26 Years of Age in Sub-Saharan Africa (V501-046)

Evaluation of Safety and Immunogenicity of GARDASIL™ in Healthy Females Between 9 and 26 Years of Age in SubSaharan Africa
Merck Sharp & Dohme LLC·Phase 3·ClinicalTrials.gov·biologicalCompleted
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Study focus
Disease/Condition
Papillomavirus Infections
Drug/Device/Intervention
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™)
Study type
Interventional
Intervention type
biological
Sponsor & location
Primary sponsor
Merck Sharp & Dohme LLC
Timeline & enrollment
Phase
Phase 3
Start date
Mar 21, 2011
End date
Apr 15, 2013
Enrollment
250 participants
Primary outcome

Number of Participants Who Seroconvert to Human Papillomavirus (HPV) Type 6,Number of Participants Who Seroconvert to HPV Type 11,Number of Participants Who Seroconvert to HPV Type 16,Number of Participants Who Seroconvert to HPV Type 18,Number of Participants With Injection-site Adverse Experiences,Number of Participants With Elevated Temperature (Oral Temperature =100 °F),Number of Participants With Serious Adverse Experiences

Summary

The study is designed to determine the safety, tolerability and immunogenicity of a 3-dose
 regimen of GARDASIL™ administered to healthy females between 9 and 26 years of age, in
 Sub-Saharan Africa. Data from the current study are needed in order to complement existing
 extensive safety data from the GARDASIL™ clinical trials program, and confirm that GARDASIL™
 may be administered safely and will induce immune responses in populations from and living in
 Sub-Saharan Africa, as GARDASIL™ has not previously been studied in this region of the world.

ICD-10 classifications
Papillomavirus as the cause of diseases classified to other chaptersPapovavirus infection, unspecified sitePapilloedema, unspecifiedViral infection, unspecifiedParvovirus as the cause of diseases classified to other chapters
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT01245764
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT01245764 through Pure Global AI's free database. This Phase 3 trial is sponsored by Merck Sharp & Dohme LLC and is currently Completed. The study focuses on Papillomavirus Infections. Target enrollment is 250 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.