ClinicalTrials.gg
Active, not recruitingNCT07256912CervALONEUpdated Oct 5, 2026

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

A Phase 4 interventional study of quadrivalent HPV vaccine and quadrivalent HPV vaccine in Vaccine Effectiveness, HPV Vaccination and Single Dose, sponsored by International Agency for Research on Cancer. Active, not recruiting at 1 site in Zambia. Open to participants aged 9 Years to 20 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-05.

Sponsored by International Agency for Research on Cancer · Phase 4, Interventional, and Prevention

Updated Oct 5, 2026Now Active, not recruitingStart date movedGo to Updates ↓

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Phase
Phase 4
Study type
Interventional
Enrollment
1,266
Allocation
Randomized
Ages
9 Years to 20 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 13 studies testing Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 in Uterine Cervical Neoplasms — none open to participants now, 2 under way, none of them phase 3. Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 · Uterine Cervical Neoplasms.

Planned enrollment
7th of 13
1,266 · median 1,266
Started
2026
the only one that year
Phase 4
4 of 13
none open now
Registered
13th of 13
by date
Lead sponsor
1 of 13
International Agency for Research on Cancer

Among the 13 studies testing Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 in Uterine Cervical Neoplasms, this one is the 7th largest by planned enrollment, is the only one that started in 2026, is one of 4 in phase 4, and was the 13th registered.

Uterine Cervical Neoplasms

2,366 studies on the registry are indexed under Uterine Cervical Neoplasms; 677 are open to participants now.

Browse Uterine Cervical Neoplasms studies →

Open to participants now

None of the 13 studies testing Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 in Uterine Cervical Neoplasms is open now. The open studies under Uterine Cervical Neoplasms, anywhere →

About Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

No approval found in the FDA or EMA files read. How studies give it is on its page →

Who these studies take

Of the 474 Uterine Cervical Neoplasms studies recruiting now, 243 (51%) set no upper age limit and 191 (40%) stop at 75 or younger; 20 take children under 18; 69 take healthy volunteers.

This study: 9 Years to 20 Years · all sexes · healthy volunteers too.

The full table on the hub →

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Download CSVNarrow it in search →With an account: the 13 studies testing Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 in Uterine Cervical Neoplasms as a file.
02

Study 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.

03

Conditions studied

  • Vaccine Effectiveness
  • HPV Vaccination
  • Single Dose
  • Immunogenicity
  • Cervical Cancer Prevention
  • Quadrivalent HPV Vaccine

Keywords

  • HPV
  • VACCINE
  • SINGLE DOSE
  • cervical cancer prevention
  • Quadrivalent HPV vaccine
04

Who can participate

Ages eligible
9 Years to 20 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Girl/woman between 9 and 20 years of age and boy between the age of 9 and 14 years at the time of recruitment.
  2. Participant willing to sign a written (for participants 18 years of age and above).
  3. 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).
  4. Participant or parent (s) willing to comply with all study requirements.
  5. 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

Exclusion Criteria:

  1. Participants who are sexually active and missed their last menstrual period will have a urine pregnancy test and will be excluded if found pregnant.
  2. Participant has a known history of prior vaccination with any HPV vaccine.
  3. Participant known to be positive (no routine HIV testing will be performed unless clinically indicated)
  4. Participant currently enrolled in any other clinical studies of products.
  5. Participant with a current diagnosis or prior history of genital warts or treatment of genital warts.
  6. Participant with a current diagnosis or prior history of cervical intraepithelial neoplasia (CIN) or cervical cancer.
  7. 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).
  8. 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.
  9. Bleeding diathesis or uncontrolled condition associated with prolonged bleeding that would, in the opinion of the Investigator, contraindicate IM injection.
  10. Participant has history of major congenital defects or illness that requires medical therapy, as determined by MH or clinical assessment.
  11. Participant has had chronic administration (defined as more than 14 days) of high doses of (prednisone or equivalent at a dose of >0.5 mg/kg/day), cytotoxic agents or radiotherapy or immunoglobulins, or other immune-modifying drugs in last 3 months or planned at any time during the study.
  12. Participant has history of receiving a blood transfusion or other blood products in three months prior to screening.
  13. Planned administration of a vaccine not foreseen by the study protocol within 14 days before and 14 days after any dose of study vaccine except TT given for emergency use and any vaccine mandated by government program.
  14. Participant has history of any major pulmonary, cardiovascular, renal, neurological, metabolic, gastro-intestinal, hepato-biliary, hematological functional abnormality, mental or physical disability, blood dyscrasia or any condition which in the opinion of the Investigator might interfere with the evaluation of the study objectives.
  15. Participant has history of any cancer, organ transplant or any other immune system disease.
  16. Individuals who, in the opinion of the investigator, are unlikely to be compliant to all study procedures
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
1,266 participants (estimated)

Study arms

  • Experimental
    Girls/women and boys vaccinated with single dose CERVAVAC-4 vaccine

    CERVAVAC-4 single dose vaccine will be administered - off label in one arm

    Biological: quadrivalent HPV vaccine

  • Active comparator
    Girls/women and boys vaccinated with single dose Gardasil-4 vaccine

    Gardasil-4 single dose vaccine will be administered in one arm

    Biological: quadrivalent HPV vaccine

Interventions

06

What researchers measure

Primary outcomes

  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

    Time frame: 24 months

07

Study locations

1 site
  • Chipata and Matero First Level Hospitals
    Lusaka, Zambia
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2026 (actual). Primary completion is estimated for Dec 2028, 30 months after the start.

Of 19 phase 4 interventional studies under Uterine Cervical Neoplasms, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 86. This study's planned 30 months is below that.

Start moved once since we started tracking on Sep 25, 2026: Apr 2026 → Jun 2026, on Oct 5, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Nov 20, 2025
First posted
Dec 1, 2025
StartActual
Jun 1, 2026was Apr 2026
Primary completionEst.
Dec 1, 2028
CompletionEst.
Jan 15, 2029
Last update
Oct 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Active, not recruiting
changed Oct 5, 2026
Start date
Apr 1, 2026→Jun 1, 2026 (actual)
Oct 5, 2026
Show all 1 update
  1. Oct 5, 2026
    Not yet recruiting→Active, not recruiting
    Start date Apr 1, 2026→Jun 1, 2026 (now actual)
    + 2 other changes: verification date and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07256912
Lead sponsor
International Agency for Research on Cancer
Responsible party
Ravivarman Lakshmanasamy (Public Health Officer, International Agency for Research on Cancer) — Principal investigator
First posted
Dec 1, 2025
Start date
Jun 1, 2026
Primary completion
Dec 1, 2028 (estimated)
Completion
Jan 15, 2029 (estimated)
Last update
Oct 5, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

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