Human Papillomavirus (HPV) InfectionPhase 3NCT07824310
Immunogenicity and Safety of HPV-4 Vaccine With or Without Td Vaccine in Children
A Phase 3 study testing Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine and Tetanus-Diphtheria booster in people with Human Papillomavirus (HPV) Infection, run by PT Bio Farma at 1 site in Indonesia.
Trial summary
This study will evaluate the safety and immune response of a single dose of a quadrivalent human papillomavirus (HPV) vaccine when given together with a tetanus-diphtheria (Td) vaccine in healthy children and adolescents aged 9 to 15 years. Read more about this study
- Who is it for?
- Ages 9 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus (HPV) Infection
- What is being tested?
- Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine and Tetanus-Diphtheria booster
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 1 siteIndonesia
- Study dates
- Oct 2026to 31 Jan 2027
- Phase
- Phase 3
- 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 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 9-15 years;
- Healthy;
- Subject/parent or LAR appropriately informed and consent/assent signed;
- Willing to comply with investigator instructions and study schedule.
Who cannot join
- Concurrent/other trial;
- Evolving illness/fever ≥37.5°C;
- Allergy to vaccine components;
- Uncontrolled coagulopathy/blood disorder contraindicating IM injection;
- Recent treatment likely to alter immune response; 6. Pregnancy/breastfeeding;
- 7. Abnormality/chronic disease interfering with objectives; 8. History of HPV/diphtheria/tetanus infection; 9. Previous HPV vaccination.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Safety and Immunogenicity of Co-administering Human Papillomavirus (HPV) Vaccine With Td Vaccines in Healthy Population Aged 9-15 Years Old in Indonesia
This study will evaluate the safety and immune response of a single dose of a quadrivalent human papillomavirus (HPV) vaccine when given together with a tetanus-diphtheria (Td) vaccine in healthy children and adolescents aged 9 to 15 years. The study will compare participants who receive the HPV vaccine together with the Td vaccine with those who receive the HPV vaccine alone. The study will assess whether giving the two vaccines together produces an immune response to HPV that is not lower than giving the HPV vaccine alone.
Read the detailed description
This study is a randomized, open-label, two-arm, parallel-group, prospective interventional Phase III trial designed to evaluate the immunogenicity and safety of a quadrivalent human papillomavirus (HPV) vaccine when administered concomitantly with a tetanus-diphtheria (Td) vaccine in healthy children and adolescents aged 9 to 15 years.
Participants will be assigned to receive the quadrivalent HPV vaccine together with the Td vaccine or the quadrivalent HPV vaccine alone. The study will assess antibody responses to the HPV vaccine antigens. Safety will be evaluated throughout the study by monitoring solicited and unsolicited adverse events, serious adverse events, and other clinically relevant safety findings.
The study is intended to provide clinical evidence on the concomitant administration of the quadrivalent HPV vaccine with Td vaccine in the target pediatric population.
- Conditions
- Human Papillomavirus (HPV) Infection
- Being tested
- Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine, Tetanus-Diphtheria booster
- Medical subject headings
- Papillomavirus Infections, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant VaccineBiological
A single 0.5 mL dose of quadrivalent recombinant human papillomavirus (HPV) vaccine targeting HPV types 6, 11, 16, and 18, administered by intramuscular injection.
Tetanus-Diphtheria boosterBiological
Also called Bio Td, Td Vaccines
A single 0.5 mL dose of Adsorbed Td (Tetanus-Diphtheria Toxoid) Vaccine Bio Farma containing purified tetanus toxoid and purified diphtheria toxoid.
| Study group | Role | What they receive |
|---|---|---|
| 4vHPV + Td vaccine | Experimental | Participants receive a single dose of quadrivalent HPV vaccine co-administered with Td vaccine. Receives: Biological: Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine; Biological: Tetanus-Diphtheria booster |
| 4vHPV alone | Active comparator | Participants receive a single dose of quadrivalent HPV vaccine alone. Receives: Biological: Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and percentage of subjects seroconverted for anti-HPV types 6, 11, 16, and 18
Number and percentage of subjects who seroconvert for anti-HPV types 6, 11, 16, and 18. Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined lower limit of quantification (LLOQ) in the serum of subjects who are seronegative before vaccination, as measured by enzyme-linked immunosorbent assay (ELISA). The seroconversion rate in the group receiving 4vHPV vaccine co-administered with Td vaccine will be compared with that in the group receiving 4vHPV vaccine alone to evaluate non-inferiority.
Measured: 28 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study startOct 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus (HPV) InfectionStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 266 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PT Bio Farma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dominicus Husada, Professor, Principal investigator, Dr. Soetomo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07824310
- Sponsor's protocol ID
- HPV 0326
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Immunogenicity of Co-administering Human Papillomavirus (HPV) Vaccine With Td Vaccines in Healthy Population Aged 9-15 Years Old in Indonesia
- ClinicalTrials.gov ID
- NCT07824310
- Acronym / sponsor ID
- HPV 0326
- Conditions
- Human Papillomavirus (HPV) Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 266 participants (estimated)
- Lead sponsor
- PT Bio FarmaIndustry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 17 Sep 2026 (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.
This study will evaluate the safety and immune response of a single dose of a quadrivalent human papillomavirus (HPV) vaccine when given together with a tetanus-diphtheria (Td) vaccine in healthy children and adolescents aged 9 to 15 years. The study will compare participants who receive the HPV vaccine together with the Td vaccine with those who receive the HPV vaccine alone. The study will assess whether giving the two vaccines together produces an immune response to HPV that is not lower than giving the HPV vaccine alone.
Detailed description
This study is a randomized, open-label, two-arm, parallel-group, prospective interventional Phase III trial designed to evaluate the immunogenicity and safety of a quadrivalent human papillomavirus (HPV) vaccine when administered concomitantly with a tetanus-diphtheria (Td) vaccine in healthy children and adolescents aged 9 to 15 years.
Participants will be assigned to receive the quadrivalent HPV vaccine together with the Td vaccine or the quadrivalent HPV vaccine alone. The study will assess antibody responses to the HPV vaccine antigens. Safety will be evaluated throughout the study by monitoring solicited and unsolicited adverse events, serious adverse events, and other clinically relevant safety findings.
The study is intended to provide clinical evidence on the concomitant administration of the quadrivalent HPV vaccine with Td vaccine in the target pediatric population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4vHPV + Td vaccine | Experimental | Biological: Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine, Biological: Tetanus-Diphtheria boosterParticipants receive a single dose of quadrivalent HPV vaccine co-administered with Td vaccine. |
| 4vHPV alone | Active comparator | Biological: Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant VaccineParticipants receive a single dose of quadrivalent HPV vaccine alone. |
Who may qualify
- Ages
- 9 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age 9-15 years;
- Healthy;
- Subject/parent or LAR appropriately informed and consent/assent signed;
- Willing to comply with investigator instructions and study schedule.
Key exclusion criteria (6 listed)
- Concurrent/other trial;
- Evolving illness/fever ≥37.5°C;
- Allergy to vaccine components;
- Uncontrolled coagulopathy/blood disorder contraindicating IM injection;
- Recent treatment likely to alter immune response; 6. Pregnancy/breastfeeding;
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 Human Papillomavirus (Types 6,11,16,18) Recombinant VaccineA single 0.5 mL dose of quadrivalent recombinant human papillomavirus (HPV) vaccine targeting HPV types 6, 11, 16, and 18, administered by intramuscular injection. | Biological | 4vHPV + Td vaccine, 4vHPV alone |
| Tetanus-Diphtheria boosterAlso: Bio Td, Td VaccinesA single 0.5 mL dose of Adsorbed Td (Tetanus-Diphtheria Toxoid) Vaccine Bio Farma containing purified tetanus toxoid and purified diphtheria toxoid. | Biological | 4vHPV + Td vaccine |
Primary outcome
Number and percentage of subjects seroconverted for anti-HPV types 6, 11, 16, and 18
Time frame: 28 days after vaccination
Number and percentage of subjects who seroconvert for anti-HPV types 6, 11, 16, and 18. Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined lower limit of quantification (LLOQ) in the serum of subjects who are seronegative before vaccination, as measured by enzyme-linked immunosorbent assay (ELISA). The seroconversion rate in the group receiving 4vHPV vaccine co-administered with Td vaccine will be compared with that in the group receiving 4vHPV vaccine alone to evaluate non-inferiority.
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 17 Sep 2026.
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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.
Dominicus Husada, Professor principal investigator
Dr. Soetomo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine and Tetanus-Diphtheria booster in people with Human Papillomavirus (HPV) Infection, run by PT Bio Farma at 1 site in Indonesia.
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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 17 Sep 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 Indonesia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Rini Mulia Sari, MD (+622033755 ext. 14102, rini.mulia@biofarma.co.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and percentage of subjects seroconverted for anti-HPV types 6, 11, 16, and 18 (time frame: 28 days after vaccination). 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 17 Sep 2026.