A Bridging Study of a Recombinant Human Papillomavirus 16/18 Bivalent Vaccine in Preadolescent Girls (NCT02562508) | Clinical Trial Compass
CompletedPhase 3
A Bridging Study of a Recombinant Human Papillomavirus 16/18 Bivalent Vaccine in Preadolescent Girls
China979 participantsStarted 2015-12-05
Plain-language summary
This is a bridging trial of the recombinant HPV 16/18 bivalent vaccine manufactured by Xiamen Innovax Biotech CO., LTD.The primary objective of this study is to evaluate the immunogenicity (type specific IgG antibody) and safety of the tested vaccine administered in girls aged 9-17 years is non-inferior to young healthy adults of 18-26 years according to the standard 3-dose schedule (0,1,6 months). Meanwhile, this study tries to compare the difference of safety and immunogenicity among different schedules (0-6m vs 0-1-6m).
Who can participate
Age range9 Years – 26 Years
SexFEMALE
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Inclusion criteria
✓. Females aged between 9 and 26 years when they receive the first vaccination (9≤age\<27);
✓. Participants aged 9-17 years whose legal guardian can provide identity certificate, or representative can provide authorization;
✓. Judged as healthy and eligible for vaccination by the investigators through a self-reported medical history and some physical examinations;
✓. Participants aged 9-17 years, able to sign or whose legal guardian agree to sign the written informed consent; or participants aged 18-26 years and agree to sign the written informed consent;
✓. Able to comply with the requests of the study;
✓. Axillary temperature not higher than 37.0°C;
✓. Nonpregnancy verified by a urine pregnancy test;
Exclusion criteria
✕. Pregnant or lactating woman and any woman who are willing or intend to become pregnant in next 7 months;
✕
What they're measuring
1
Anti-HPV16 and anti-HPV18 seroconversion rates and geometric mean concentrations at Months 7 (type specific IgG antibody)
. Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the first vaccination, or plan to use during the study period;
✕. Participants who received an immunosuppressive agent or other immunomodulator agent for a long term (for 14 days or more) within 6 months of the first vaccination, or systematic corticosteroid (however, a topical corticosteroid is allowed, such as ointment, eye drops, inhalant, or nasal spray);
✕. Participants who received immunoglobulin and/or blood product 3 months prior to the first vaccination, or planned to receive during the study period;
✕. Use of any inactivated vaccine 14 days preceding dosing of study vaccine or attenuated vaccine 21 days before the enrollment;
✕. Participants had fever (auxiliary temperature ≥38.0 °C) within 3 days prior to vaccination, or any acute disease requiring systematic antibiotics or antiviral therapy within the past 5 days;
✕. Concurrently participating another clinical trial;