A Trial to Establish Non-inferiority of Immunogenicity of a Single-dose of CERVAVAC® Quadrivalent… (NCT07256912) | Clinical Trial Compass
Not Yet RecruitingPhase 4
A Trial to Establish Non-inferiority of Immunogenicity of a Single-dose of CERVAVAC® Quadrivalent HPV Vaccine Compared to the Gardasil® Quadrivalent Vaccine Among Girls and Boys Aged 9 to 14 Years and in Girls/Women Aged 15 to 20 Years in Zambia
Zambia1,266 participantsStarted 2026-04-01
Plain-language summary
The goal of this study is to compare the immune response of the single dose of the CERVAVAC vaccine with the single dose of Gardasil vaccine in girls/women aged 9 to 20 and boys aged 9 to 14 at 6 months, 12 months and 24 months post vaccination. The vaccine will be given randomly to the boys and girls/women in these age group and they will be followed up to check the immune status developed in them after vaccination. The status of immune response developed by the two differnet vaccines will be compared in these group of participants of the study.
Who can participate
Age range
9 Years – 20 Years
Sex
ALL
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
. Girl/woman between 9 and 20 years of age and boy between the age of 9 and 14 years at the time of recruitment.
. Participant willing to sign a written informed consent (for participants 18 years of age and above).
. Parent (s) willing to provide written informed consent and participant is willing to sign written assent form for participation (for participants below 18 years of age at the time of eligibility assessment).
. Participant or parent (s) willing to comply with all study requirements.
. Participants who are determined by Medical History (MH), Physical Examination (PE) and clinical judgment of the Investigator to be eligible for inclusion in the study.
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
1
Geometric mean Titre (GMT) of IgG antibodies against HPV 16 and 18 assessed from blood samples collected at 24 months and measured by M9ELISA on Meso-scale Discovery (MSD®) platform
Timeframe: 24 months
Trial details
NCT IDNCT07256912
SponsorInternational Agency for Research on Cancer
. Participants who are sexually active and missed their last menstrual period will have a urine pregnancy test and will be excluded if found pregnant.
. Participant has a known history of prior vaccination with any HPV vaccine.
. Participant known to be HIV positive (no routine HIV testing will be performed unless clinically indicated)
. Participant currently enrolled in any other clinical studies of investigational products.
. Participant with a current diagnosis or prior history of genital warts or treatment of genital warts.
. Participant with a current diagnosis or prior history of cervical intraepithelial neoplasia (CIN) or cervical cancer.
. Participant has a history of any allergic diseases or severe allergic reaction to any agent/vaccine product (e.g., swelling of the mouth and throat, difficulty in breathing, hypotension, or shock).
. Participant has had an acute illness (moderate or severe) and/or fever (body temperature ≥ 38°C or ≥ 100.4 °F) at the time of vaccination or during the 72 hours prior to the vaccination.