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 range

13 Years – 14 Years

Sex

FEMALE

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Evaluate seroconversion rates and geometric mean concentrations of anti-measles at the 1st month after MMR vaccination

Timeframe: 1 months after vaccination

Evaluate seroconversion rates and geometric mean concentrations of anti-rubella at the 1st month after MMR vaccination

Timeframe: 1 months after vaccination

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

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2022-12-31

View on ClinicalTrials.gov More Human Papilloma Virus Infection Type 16 trials

Who can participate

Age range

13 Years – 14 Years

Sex

FEMALE

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

What they're measuring

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

Evaluate seroconversion rates and geometric mean concentrations of anti-measles at the 1st month after MMR vaccination

Timeframe: 1 months after vaccination

Evaluate seroconversion rates and geometric mean concentrations of anti-rubella at the 1st month after MMR vaccination

Timeframe: 1 months after vaccination

Evaluate seroconversion rates and geometric mean concentrations of anti-mumps at the 1st month after MMR vaccination

Timeframe: 1 months after vaccination