The Immunogenicity and Safety of the Vaccination of Human Papillomavirus Vaccine and Measles-Mump… (NCT05279248) | Clinical Trial Compass
UnknownPhase 4
The Immunogenicity and Safety of the Vaccination of Human Papillomavirus Vaccine and Measles-Mumps-Rubella Vaccine
China300 participantsStarted 2021-08-25
Plain-language summary
The purpose of this study is to evaluate the immunogenicity and safety of Recombinant Human Papillomavirus Bivalent (Types 16,18) Vaccine (Escherichia coli) （HPV）and Measles Mumps and Rubella Combined Vaccine, Live（MMR）
Who can participate
Age range13 Years – 14 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Females aged between 13 and 14 years when they receive the first vaccination (13≤age\<15);
✓. Participants aged 13-14 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 13-14 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;
✕. 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;
What they're measuring
1
Evaluate the seroconversion rates and geometric mean concentrations of anti-HPV 16 and 18 at Months 7 (type specific neutralizing antibody)
Timeframe: Specific neutralizing antibodies at 7 months after first dose
2
Evaluate seroconversion rates and geometric mean concentrations of anti-measles at the 1st month after MMR vaccination
Timeframe: 1 months after vaccination
3
Evaluate seroconversion rates and geometric mean concentrations of anti-rubella at the 1st month after MMR vaccination
Timeframe: 1 months after vaccination
4
Evaluate seroconversion rates and geometric mean concentrations of anti-mumps at the 1st month after MMR vaccination
Timeframe: 1 months after vaccination
Trial details
NCT IDNCT05279248
SponsorZhejiang Provincial Center for Disease Control and Prevention
✕. 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;