NCT06681636Not yet recruitingPhase 2
Effector and Memory Immune Responses to HPV Vaccination in Vietnamese Women Post Virus Exposure
A Non-inferiority Study Comparing the Immunogenicity of a Standard or an Extended Three-dose Nonavalent Human Papillomavirus Vaccine Schedule Between High-risk Women Aged 18-26 Years and Age-matched Women in the General Population
Source: ClinicalTrials.gov · Last updated 8 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
A Study to evaluate if the 3 dose extended schedule (0-6-18 months) for the HPV vaccine Gardasil-9 provide similar immune responses and short term protection against HPV infection compared to the regular 3 dose schedule (0-2-6 months) in high risk women in Vietnam
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 5 Nov 2024
- Start date
- 14 Dec 2024
- Primary completion date
- 31 Oct 2026
- Lead sponsor
- National Institute of Hygiene and Epidemiology, Vietnam
- Diseases
- Cervical cancer
- NCT number
- NCT06681636
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 300
- From 14 Dec 2024 to the primary completion date, 31 Oct 2026
- 3 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has received any HPV vaccine previously
- Currently receiving immunosuppressive medication or anti-cancer chemotherapy.
Other illness
- Known allergies to any vaccine component
- Known HIV infection.
- Known Congenital immune deficiency syndrome.
Other
- Participants meeting any of the following criteria will be excluded from the trial:
- Pregnant or possibly pregnant
- Has an axillary temperate greater than 38°C
- incapacity to provide consent
Who the study is looking for
- Is between the reporting ages of 18-26 years at the time of recruitment.
- Engage in commercial sex in the last 6m (for FSW group) or have engaged in sexual activity (non-FSWs)
- Willing and able to give written informed consent.
- Willing to complete the follow-up requirements of the study.
Age in the registry: 18 years to 26 years · Sex: Female · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Murdoch Children Research Institute Coordinator of this site? Confirm its status | Parkville | Australia | Unknown status |
| Hai Phong Center for Disease Control Coordinator of this site? Confirm its status | Haiphong | Vietnam | Unknown status |
| Center for Supporting Community Development Initiatives SCDI-Vietnam Coordinator of this site? Confirm its status | Haiphong | Vietnam | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.