This study is designed to evaluate the immunogenicity, safety, and tolerability of Gardasil® (quadrivalent human papillomavirus \[qHPV\] vaccine, V501) in Chinese girls aged 9-19 years and young women aged 20-26 years. The primary hypothesis of the study states that at 1 month postdose 3, a 3-dose regimen of V501 induces non-inferior geometric mean titers (GMTs) for serum anti-HPV 6, anti-HPV 11, anti-HPV 16, anti-HPV 18 in girls aged 9-19 years compared to young women aged 20-26 years.
The study consists of a Base Stage wherein Chinese girls aged 9-19 years and young women aged 20-26 years receive a 3-dose regimen of V501 and are followed up to 1 month postdose 3 (Month 7). Participants aged 9-19 years who received 3 doses of V501 in the Base Stage will be eligible to participate in the Extension Stage and will be followed up to Month 60. No study vaccine will be administered during the Extension Stage.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
766
0.5 mL intramuscular injection in the deltoid muscle at Day 1, Month 2, and Month 6
Yangchun Center For Disease Prevention And Control ( Site 0003)
Yangchun, Guangdong, China
Base Stage: Geometric Mean Titers for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18: Competitive Luminex Immunoassay (cLIA)
Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using a Competitive Luminex Immunoassay (cLIA). Antibody titers were expressed as milli Merck Units/milliliter (mMU/mL).
Time frame: Month 7 (1 month postdose 3)
Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 12 Assessed by cLIA
Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using a Competitive Luminex Immunoassay (cLIA). Antibody titers were expressed as (mMU/mL).
Time frame: Month 12 post-vaccination 1
Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 24 Assessed by cLIA
Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using a Competitive Luminex Immunoassay (cLIA). Antibody titers were expressed as (mMU/mL).
Time frame: Month 24 post-vaccination 1
Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 36 Assessed by cLIA
Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using a Competitive Luminex Immunoassay (cLIA). Antibody titers were expressed as (mMU/mL).
Time frame: Month 36 post-vaccination 1
Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 48 Assessed by cLIA
Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using a Competitive Luminex Immunoassay (cLIA). Antibody titers were expressed as (mMU/mL).
Time frame: Month 48 post-vaccination 1
Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 60 Assessed by cLIA
Serum antibody titers (Geometric mean titers) for HPV virus-like particles (VLPs) Types 6, 11, 16, and 18 were measured. Antibodies were measured using a Competitive Luminex Immunoassay (cLIA). Antibody titers were expressed as (mMU/mL).
Time frame: Month 60 post-vaccination 1
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 12 Assessed by cLIA
The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using cLIA.
Time frame: Month 12 post-vaccination 1
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 24 Assessed by cLIA
The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using cLIA.
Time frame: Month 24 post-vaccination 1
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 36 Assessed by cLIA
The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using cLIA.
Time frame: Month 36 post-vaccination 1
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 48 Assessed by cLIA
The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using cLIA.
Time frame: Month 48 post-vaccination 1
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 60 Assessed by cLIA
The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using cLIA.
Time frame: Month 60 post-vaccination 1
Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 12 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)
Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using IgG LIA. Antibody titers were expressed as (mMU/mL).
Time frame: Month 12 post-vaccination 1
Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 24 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)
Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using IgG LIA. Antibody titers were expressed as (mMU/mL).
Time frame: Month 24 post-vaccination 1
Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 36 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)
Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using IgG LIA. Antibody titers were expressed as (mMU/mL).
Time frame: Month 36 post-vaccination 1
Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 48 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)
Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using IgG LIA.
Time frame: Month 48 post-vaccination 1
Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 60 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)
Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using IgG LIA.
Time frame: Month 60 post-vaccination 1
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 12 Assessed by IgG LIA
The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using IgG LIA.
Time frame: Month 12 post-vaccination 1
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 24 Assessed by IgG LIA
The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using IgG LIA.
Time frame: Month 24 post-vaccination 1
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 36 Assessed by IgG LIA
The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using IgG LIA.
Time frame: Month 36 post-vaccination 1
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 48 Assessed by IgG LIA
The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using IgG LIA.
Time frame: Month 48 post-vaccination 1
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 60 Assessed by IgG LIA
The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using IgG LIA.
Time frame: Month 60 post-vaccination 1
Base Stage: Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18: cLIA
Seroconversion is defined as changing serostatus from seronegative at Day 1 to seropositive at 1 month post dose 3. Antibodies were measured using a Competitive Luminex Immunoassay (cLIA). Antibody titers were expressed as milli Merck Units/milliliter (mMU/mL).
Time frame: Month 7 (1 month postdose 3)
Base Stage: Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18: IgG LIA
Antibodies to HPV Types 6, 11, 16, and 18 were measured using an IgG LIA. Antibody titers were expressed as milli Merck Units/milliliter (mMU/mL).
Time frame: Month 7 (1 month postdose 3)
Base Stage: Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18: IgG LIA
The percentage of participants who seroconverted to each of HPV Types 6, 11, 16, and 18 was assessed. Antibodies were measured using IgG LIA.
Time frame: Month 7 (1 month postdose 3)
Base Stage: Percentage of Participants Who Experienced a Solicited Injection-site Adverse Event (AE)
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs included injection-site redness, swelling, induration, pain, and pruritus.
Time frame: Up to 15 days after any vaccination
Base Stage: Percentage of Participants Participants Who Experienced a Solicited Systemic AE
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs included hypersensitivity, headache, fatigue, vomiting, nausea, diarrhea, myalgia, pyrexia, and cough.
Time frame: Up to 15 days after any vaccination
Base Stage: Percentage of Participants Who Experienced a Serious Adverse Event (SAE)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
An SAE is an AE that results in death, is life threatening, requires hospitalization or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, according to medical or scientific judgment, may jeopardize the participant or requires medical or surgical intervention to prevent one of the other outcomes listed in the above definition.
Time frame: Up to Month 7 (1 month postdose 3)
Base Stage: Percentage of Participants Who Experienced an AE
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment
Time frame: Up to 31 days after any vaccination
Base Stage: Maximum Axillary Temperature: Merck Sharp & Dohme (MSD) Criteria
In the global studies, fever is defined as an oral temperature of ≥37.8°C or 100.0°F, which is equivalent to axillary temperature of ≥37.2°C, while the definition of fever is axillary temperature of ≥37.1°C in Chinese criteria. To be compliant to Chinese criteria, axillary temperatures of ≥37.1°C was considered as a fever in this study. Body temperature readings assessed orally were converted to the axillary equivalent. The percentage of participants with a maximum axillary or converted axillary temperature was summarized by temperature range.
Time frame: Up to 5 days after any vaccination
Extension Stage: Percentage of Participants Who Experienced an SAE
The percentage of participants with an SAE will be assessed. An SAE is an AE that results in death, is life threatening, requires hospitalization or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, according to medical or scientific judgment, may jeopardize the participant or requires medical or surgical intervention to prevent one of the other outcomes listed in the above definition.
Time frame: Month 7 up to Month 60