CompletedPhase 1

A Study of Safety and Primary Immunogenicity of 9-valent HPV Recombinant Vaccine

China90 participantsStarted 2019-03-09

Plain-language summary

A randomized, double-blind and placebo-controlled phase I study to evaluate the safety and immunogenicity of a 9-valent Human Papillomavirus (HPV) vaccine, administered intramuscularly according to a 0, 2, 6-month schedule in 9 to 45 years old healthy Chinese females.

Who can participate

Age range

9 Years – 45 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: * Healthy females, 9 to 45 years old (inclusive). * 9 to 17 years old participants: able to prove their identities and provide their legal guardians' identity information. * Legal guardians of the 9 to 17 years old participants: able to understand (not illiterate) and agree to co-sign the informed consent forms with participants * 18 to 45 years old participants: able to prove their legal identities. * 18 to 45 years old participants: able to understand (not illiterate) the study and agree to sign the informed consent form. * Child bearing age participants: agree not to become pregnant by using proper contraception means in the 7-month study period. Exclusion Criteria: * History of cervical cancer or genital warts. * History HPV vaccination or history of participation in HPV vaccine trial. * History of severe allergy which needs medical intervention such as swelling of the mouth and throat, difficulty breathing, hypotension or shock. * Skin abnormality at injection site including inflammation, sclerosis, redness, swelling, and extensive scars. * History of allergy to vaccine or vaccine components including aluminum phosphate, histidine and Polysorbate 80, and severe adverse reactions in past vaccination. * Medical history of epilepsy, convulsions, seizures , or family history of mental illness. * Medical conditions including immunocompromised or diagnosed as congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus eryth…

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

Percentage of Subjects Reporting Solicited Local Symptoms

Timeframe: During a 8-day period (Day 0-7) following each vaccination

Percentage of Subjects Reporting Solicited General Symptoms

Timeframe: During a 8-day period (Day 0-7) following each vaccination

Percentage of Subjects Reporting Unsolicited Adverse Events (AEs)

Timeframe: Within 31 days (Day 0-30) after any vaccination

Percentage of Subjects Reporting Serious Adverse Events (SAE)

Timeframe: Throughout the study period (up to Month 12)

Trial details

NCT IDNCT03900572

SponsorShanghai Zerun Biotechnology Co.,Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-04-30

View on ClinicalTrials.gov More HPV Infections trials

Who can participate

Age range

9 Years – 45 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.

What they're measuring

Percentage of Subjects Reporting Solicited Local Symptoms

Timeframe: During a 8-day period (Day 0-7) following each vaccination

Percentage of Subjects Reporting Solicited General Symptoms

Timeframe: During a 8-day period (Day 0-7) following each vaccination

Percentage of Subjects Reporting Unsolicited Adverse Events (AEs)

Timeframe: Within 31 days (Day 0-30) after any vaccination

Percentage of Subjects Reporting Serious Adverse Events (SAE)

Timeframe: Throughout the study period (up to Month 12)