GARDASIL™ Study in Healthy Females Between 9 and 26 Years of Age in Sub-Saharan Africa (V501-046) - Trial NCT01245764
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.
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Study Focus
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™)
Interventional
biological
Sponsor & Location
Merck Sharp & Dohme LLC
Timeline & Enrollment
Phase 3
Mar 21, 2011
Apr 15, 2013
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
Data Source
ClinicalTrials.gov
NCT01245764
Non-Device Trial