Vaccine EffectivenessPhase 4CervALONENCT07256912
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 study testing quadrivalent HPV vaccine in people with Vaccine Effectiveness and HPV Vaccination, run by International Agency for Research on Cancer at 1 site in Zambia.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaccine Effectiveness, HPV Vaccination, Single Dose
- What is being tested?
- quadrivalent HPV vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,266 participants
- Where
- 1 siteZambia
- Study dates
- 1 Jun 2026to 15 Jan 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Bleeding diathesis or uncontrolled condition associated with prolonged bleeding that would, in the opinion of the Investigator, contraindicate IM injection.
- Participant has history of major congenital defects or illness that requires medical therapy, as determined by MH or clinical assessment.
- Participant has had chronic administration (defined as more than 14 days) of high doses of corticosteroids (prednisone or equivalent at a dose of >0.5 mg/kg/day), cytotoxic agents or radiotherapy or immunoglobulins, immunosuppressants or other immune-modifying drugs in last 3 months or planned at any time during the study.
- Participant has history of receiving a blood transfusion or other blood products in three months prior to screening.
- 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.
- 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.
- Participant has history of any cancer, organ transplant or any other immune system disease.
- Individuals who, in the opinion of the investigator, are unlikely to be compliant to all study procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Active Controlled, Assessors-blind 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
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.
- Conditions
- Vaccine Effectiveness, HPV Vaccination, Single Dose, Immunogenicity, Cervical Cancer Prevention, Quadrivalent HPV Vaccine
- Being tested
- quadrivalent HPV vaccine
- Keywords
- HPV, VACCINE, SINGLE DOSE, cervical cancer prevention, Quadrivalent HPV vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quadrivalent HPV vaccineBiological
Also called CERVAVAC single dose
CERVAVAC-4 single dose vaccine
quadrivalent HPV vaccineBiological
Also called Gardasil-4 vaccine
Gardasil-4 single dose
| Study group | Role | What they receive |
|---|---|---|
| Girls/women and boys vaccinated with single dose CERVAVAC-4 vaccine | Experimental | CERVAVAC-4 single dose vaccine will be administered - off label in one arm Receives: Biological: quadrivalent HPV vaccine |
| Girls/women and boys vaccinated with single dose Gardasil-4 vaccine | Active comparator | Gardasil-4 single dose vaccine will be administered in one arm Receives: Biological: quadrivalent HPV vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start1 Jun 2026
- Primary completion1 Dec 2028 (estimated)
- Study completion15 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine EffectivenessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,266 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Agency for Research on Cancer
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ravivarman Lakshmanasamy, International Agency for Research on Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07256912
- Sponsor's protocol ID
- CervALONE Trial
- Acronym
- CervALONE
- Status last verified
- Oct 2026
- First submitted
- 20 Nov 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Active Controlled, Assessors-blind 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
- ClinicalTrials.gov ID
- NCT07256912
- Acronym / sponsor ID
- CervALONE / CervALONE Trial
- Conditions
- Vaccine Effectiveness, HPV Vaccination, Single Dose, Immunogenicity, Cervical Cancer Prevention, Quadrivalent HPV Vaccine
- Keywords
- HPV, VACCINE, SINGLE DOSE, cervical cancer prevention, Quadrivalent HPV vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,266 participants (estimated)
- Lead sponsor
- International Agency for Research on CancerUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 15 Jan 2029 (estimated)
- First posted
- 1 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Girls/women and boys vaccinated with single dose CERVAVAC-4 vaccine | Experimental | Biological: quadrivalent HPV vaccineCERVAVAC-4 single dose vaccine will be administered - off label in one arm |
| Girls/women and boys vaccinated with single dose Gardasil-4 vaccine | Active comparator | Biological: quadrivalent HPV vaccineGardasil-4 single dose vaccine will be administered in one arm |
Who may qualify
- Ages
- 9 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| quadrivalent HPV vaccineAlso: CERVAVAC single doseCERVAVAC-4 single dose vaccine | Biological | Girls/women and boys vaccinated with single dose CERVAVAC-4 vaccine |
| quadrivalent HPV vaccineAlso: Gardasil-4 vaccineGardasil-4 single dose | Biological | Girls/women and boys vaccinated with single dose Gardasil-4 vaccine |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing quadrivalent HPV vaccine in people with Vaccine Effectiveness and HPV Vaccination, run by International Agency for Research on Cancer at 1 site in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.