Primary objective: • To demonstrate that administration of V503 induces non-inferior Geometric Mean Titers (GMTs) (for serum anti-HPV16 and anti-HPV18) compared to GARDASIL. Secondary objectives: * To evaluate the tolerability of V503 in 9-15 year-old girls. * To summarize humoral immune response (anti-HPV 6, 11, 16, 18) induced by V503 or GARDASIL.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
600
Geometric Mean Titers (GMTs) to HPV Types 16 and 18
Serum antibodies to HPV types 16 and 18 were measured with a Competitive Luminex Immunoassay.
Time frame: 4 weeks postdose 3 (Month 7)
GMTs to HPV Types 6 and 11
Serum antibodies to HPV types 6 and 11 were measured with a Competitive Luminex Immunoassay.
Time frame: 4 weeks postdose 3 (Month 7)
Percentage of Participants Who Are Seropositive for HPV Types 6/11/16/18
Serum antibodies to HPV types were measured with a Competitive Luminex Immunoassay. The serostatus cutoffs (milli Merck Units/mL) for HPV types were as follows: HPV Type 6: ≥30; HPV Type 11: ≥16; HPV Type 16: ≥20; HPV Type 18: ≥24. The percentage of participants who were seropositive according to these cutoffs was assessed.
Time frame: 4 weeks postdose 3 (Month 7)
Percentage of Participants With One or More Adverse Events
An adverse event is defined as any unfavourable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine, is also an adverse event. The percentage of participants with one or more adverse events was assessed.
Time frame: Up to Month 7
Percentage of Participants With One or More Injection-site Adverse Reactions
The percentage of participants with one or more injection-site adverse reactions (solicited or unsolicited) was assessed.
Time frame: Up to 5 days after any vaccination
Percentage of Participants With One or More Systemic Adverse Events
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The percentage of participants with one or more systemic adverse events was assessed.
Time frame: Up to 15 days after any vaccination
Percentage of Participants With Maximum Oral Temperature ≥37.8°C
The percentage of participants with maximum oral temperature ≥37.8°C was assessed.
Time frame: Up to 15 days after any vaccination
Percentage of Participants With One or More Serious Adverse Events
A serious adverse event is an adverse event that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, or may jeopardize the participant and may require medical or surgical intervention. The percentage of participants with one or more serious adverse events was assessed.
Time frame: Up to Month 7