GARDASIL™ Study in Healthy Females Between 9 and 26 Years of Age in Sub-Saharan Africa (V501-046)
- Conditions
- Papillomavirus Infections
- Interventions
- Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™)Biological: Placebo
- Registration Number
- NCT01245764
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief 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.
- Detailed Description
In Phase A of the study, healthy females between 9 and 12 years of age will be randomized (4:1) to receive the 3-dose regimen of GARDASIL™ or placebo, and those between 13 and 26 years old will receive GARDASIL™. In Phase B of the study, participants who received placebo in Phase A will have the option to receive the 3-dose regimen of GARDASIL™.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 250
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GARDASIL™ 9 to 12 Years Old Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Participants will not continue to study Phase B. GARDASIL™ 13 to 15 Years Old Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Participants will not continue to study Phase B. Placebo 9 to 12 Years Old Placebo Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. After database lock and unblinding for study Phase A, participants will have the option to receive GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase B. GARDASIL™ 16 to 26 Years Old Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Participants will not continue to study Phase B.
- Primary Outcome Measures
Name Time Method Number of Participants Who Seroconvert to HPV Type 16 Month 7 (1 month postdose 3 in study Phase A) Seroconversion was defined as achieving an anti-HPV Type 16 cLIA level of \>=20 milli Merck U/mL. The dilution-corrected limit of detection for the Type 16 cLIA was 9.7 milli Merck U/mL.
Number of Participants Who Seroconvert to HPV Type 11 Month 7 (1 month postdose 3 in study Phase A) Seroconversion was defined as achieving an anti-HPV Type 11 cLIA level of \>=16 milli Merck U/mL. The dilution-corrected limit of detection for the Type 11 cLIA was 3.9 milli Merck U/mL.
Number of Participants With Serious Adverse Experiences From the time of informed consent is signed through the last study visit (up to 19 months) A serious adverse experience is any adverse experience that results in death, is life threatening, results in persistent or significant disability/incapacity, results in or prolongs existing inpatient hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is another important medical event that may jeopardize the participant and may require medical or surgical intervention
Number of Participants Who Seroconvert to Human Papillomavirus (HPV) Type 6 Month 7 (1 month postdose 3 in study Phase A) Seroconversion was defined as achieving an anti-HPV Type 6 competitive Luminex Immunoassay (cLIA) level of \>=20 milli Merck U/mL. The dilution-corrected limit of detection for the Type 6 cLIA was 4.2 milli Merck U/mL.
Number of Participants Who Seroconvert to HPV Type 18 Month 7 (1 month postdose 3 in study Phase A) Seroconversion was defined as achieving an anti-HPV Type 18 cLIA level of \>=24 milli Merck U/mL. The dilution-corrected limit of detection for the Type 18 cLIA was 5.8 milli Merck U/mL.
Number of Participants With Injection-site Adverse Experiences Up to Day 5 after any vaccination in study Phase A Participants were prompted to report injection-site experiences of pain, erythema, or swelling and were also asked to report any other injection-site adverse experiences
Number of Participants With Elevated Temperature (Oral Temperature >=100 °F) Up to Day 5 after any vaccination in study Phase A
- Secondary Outcome Measures
Name Time Method Geometric Mean Titer (GMT) of Anti-HPV Type 6 Antibody Month 7 (1 month postdose 3 in study Phase A) Anti-HPV Type 6 antibodies were measured by cLIA. The seropositive cut-off threshold for this assay is defined as 20 milli Merck U/mL.
GMT of Anti-HPV Type 18 Antibody Month 7 (1 month postdose 3 in study Phase A) Anti-HPV Type 18 antibodies were measured by cLIA. The seropositive cut-off threshold for this assay is defined as 24 milli Merck U/mL.
GMT of Anti-HPV Type 11 Antibody Month 7 (1 month postdose 3 in study Phase A) Anti-HPV Type 11 antibodies were measured by cLIA. The seropositive cut-off threshold for this assay is defined as 16 milli Merck U/mL.
GMT of Anti-HPV Type 16 Antibody Month 7 (1 month postdose 3 in study Phase A) Anti-HPV Type 16 antibodies were measured by cLIA. The seropositive cut-off threshold for this assay is defined as 20 milli Merck U/mL.