CompletedPhase 1

A Phase I Trial Evaluate the Safety and Tolerability Profile of HPV Vaccine

China160 participantsStarted 2019-09-01

Plain-language summary

This study is to evaluate the safety and tolerability profile of Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli) in healthy women ages 18-45

Who can participate

Age range

18 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

. Female subjects 27-45 years of age (inclusive of 27 and 45 years of age);
. Subjects decided to be healthy by the principal investigator in accordance with such trial subjects' medical history and physical examination results;
. Subjects who understand and agree to comply with the study procedures and provide written informed consent;
. Subjects who are able to comply with protocol-specified requirements;
. Subjects with negative urine pregnancy test result at screening;
. Subjects with no childbearing potential (e.g. females who have undergone bilateral tubal ligation, hysterectomy, bilateral oophorectomy, etc.), or subjects with childbearing potential who have agreed to abstain from any sexual activity that could result in pregnancy or practice adequate contraception for at least 28 days prior to the first dose and throughout the study;
. Subjects with axillary temperature≤37.0℃.
. Female subjects 18-26 years of age (inclusive of 18 and 26 years of age);

Exclusion criteria

. Women who are pregnant or breastfeeding, or planning for pregnancy in the following 7 months;

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 adverse reaction(s) within 7 days post any dose of the interventions.

Timeframe: 0-7 months

Trial details

NCT IDNCT05680454

SponsorBeijing Health Guard Biotechnology, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-04-06

View on ClinicalTrials.gov More Human Papillomavirus Infection trials