Active — Not RecruitingPhase 3

Efficacy, Immunogenicity and Safety of V503 in Chinese Women Aged 20-45 Years (V503-023)

China6,000 participantsStarted 2019-06-26

Plain-language summary

This study will evaluate the efficacy, immunogenicity and safety of 9-valent human papillomavirus (9vHPV; V503) vaccine in Chinese women 20 to 45 years of age. The primary hypotheses are: 9vHPV vaccine reduces the incidence of HPV 31-, 33-, 45-, 52-, and 58-related 12-month persistent infection at least 1 month post Dose 3, compared with quadrivalent HPV (qHPV) vaccine in women 20 to 45 years of age who are seronegative at Day 1 and polymerase chain reaction (PCR) negative Day 1 through Month 7 to the relevant HPV type; and 9vHPV vaccine induces non-inferior competitive luminex immunoassay (cLIA) geometric mean titers (GMTs) for each of HPV 6, 11, 16, and 18 one month post Dose 3, compared with qHPV vaccine in women 20 to 45 years of age who are seronegative at Day 1 and PCR negative Day 1 through Month 7 to the relevant HPV type.

Who can participate

Age range

20 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 * Has not had sex with males or has had sex with males and used effective contraception with no failures since the first day of the participant's last menstrual period through Day 1 * Agrees to use effective contraception if has sex with a male partner during study * Has had sexual intercourse with male partners, and has had 1 to 4 male and/or female sexual partners Exclusion Criteria * History of a positive test for HPV * History of an abnormal Pap test result showing ASC-US, atypical squamous cells - cannot exclude HSIL (high grade squamous intraepithelial lesion \[(ASC-H)\], low-grade squamous intraepithelial lesion (LSIL), HSIL), or atypical glandular cells * History of an abnormal cervical biopsy result showing CIN, adenocarcinoma in situ or cervical cancer * History of or clinical evidence at the Day 1 gynecologic examination of HPV-related anogenital diseases (e.g., genital warts, VIN, VaIN, AIN, vulvular cancer, vaginal cancer or anal cancer * Does not have an intact cervix uteri or has more than one cervix uteri * Is pregnant * Known allergy to any vaccine component, including aluminum, yeast, or Benzonase™ (nuclease, Nycomed™ \[used to remove residual nucleic acids from this and other vaccines\]) * History of severe allergic reaction (e.g., swelling of the mouth and throat, difficulty breathing, hypotension or shock) that required medical intervention * Has thrombocytopenia or any coagulation disorder that would contraindicate intramu…

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

Stage I: Combined Incidence of HPV 31-, 33-, 45-, 52-, and 58-related 12-month Persistent Infection

Timeframe: 1 month post vaccination 3 (Month 7) up to Month 30

Stage I: Geometric Mean Titers to HPV Types 6, 11, 16, and 18 Antibodies

Timeframe: 1-month post vaccination 3 (Month 7)

Stage I: Percentage of Participants Who Report at Least 1 Solicited Injection-site Adverse Event

Timeframe: up to 8 days post any vaccination

Stage I: Percentage of Participants Who Report at Least 1 Solicited Systemic Adverse Event

Timeframe: up to 30 days post any vaccination

Stage I: Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE)

Timeframe: Day 1 up to approximately Month 30

Stage II: Combined Incidence of HPV 31-, 33-, 45-, 52-, and 58-related CIN 2/3, AIS, and cervical cancer

Timeframe: Month 7 up to Month 90

Trial details

NCT IDNCT03998254

SponsorMerck Sharp & Dohme LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-03-31

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