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.
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™.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
250
Number of Participants Who Seroconvert to Human Papillomavirus (HPV) Type 6
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.
Time frame: Month 7 (1 month postdose 3 in study Phase A)
Number of Participants Who Seroconvert to HPV Type 11
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.
Time frame: Month 7 (1 month postdose 3 in study Phase A)
Number of Participants Who Seroconvert to HPV Type 16
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.
Time frame: Month 7 (1 month postdose 3 in study Phase A)
Number of Participants Who Seroconvert to HPV Type 18
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.
Time frame: Month 7 (1 month postdose 3 in study Phase A)
Number of Participants With Injection-site Adverse Experiences
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
Time frame: Up to Day 5 after any vaccination in study Phase A
Number of Participants With Elevated Temperature (Oral Temperature >=100 °F)
Time frame: Up to Day 5 after any vaccination in study Phase A
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Number of Participants With Serious Adverse Experiences
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
Time frame: From the time of informed consent is signed through the last study visit (up to 19 months)
Geometric Mean Titer (GMT) of Anti-HPV Type 6 Antibody
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.
Time frame: Month 7 (1 month postdose 3 in study Phase A)
GMT of Anti-HPV Type 11 Antibody
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.
Time frame: Month 7 (1 month postdose 3 in study Phase A)
GMT of Anti-HPV Type 16 Antibody
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.
Time frame: Month 7 (1 month postdose 3 in study Phase A)
GMT of Anti-HPV Type 18 Antibody
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.
Time frame: Month 7 (1 month postdose 3 in study Phase A)