Immunogenicity and Safety of HPV-4 Vaccine With or Without Td Vaccine in Children

NCT07824310 | Not Yet Recruiting Phase 3

• 1 other identifier: HPV 0326
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Human Papillomavirus (HPV) Infection

Outcome Measures

Primary Outcomes (1)

• 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.

  28 days after vaccination

Study Arms (2)

4vHPV + Td vaccine

EXPERIMENTAL

Participants receive a single dose of quadrivalent HPV vaccine co-administered with Td vaccine.

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.

Biological: Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine

Interventions

Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine BIOLOGICAL

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.

4vHPV + Td vaccine; 4vHPV alone

Tetanus-Diphtheria booster BIOLOGICAL

A single 0.5 mL dose of Adsorbed Td (Tetanus-Diphtheria Toxoid) Vaccine Bio Farma containing purified tetanus toxoid and purified diphtheria toxoid.

Also known as: Bio Td, Td Vaccines

4vHPV + Td vaccine

Eligibility Criteria

• Age: 9 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age 9-15 years;
• Healthy;
• Subject/parent or LAR appropriately informed and consent/assent signed;
• Willing to comply with investigator instructions and study schedule.

You may not qualify if:

• 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;
• \. Abnormality/chronic disease interfering with objectives; 8. History of HPV/diphtheria/tetanus infection; 9. Previous HPV vaccination.

Sponsors & Collaborators

• PT Bio Farma: lead

Study Sites (1)

RSUD Dr. Soetomo

Surabaya, East Java, Indonesia

Location

MeSH Terms

Conditions

Papillomavirus Infections; Infections

Interventions

Vaccines, Synthetic

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; Antigens; Biological Factors

Study Officials

• Dominicus Husada, Professor

  Dr. Soetomo General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rini Mulia Sari, MD

CONTACT

+622033755; rini.mulia@biofarma.co.id

Mita Puspita, MD

CONTACT

+622033755; mita.puspita@biofarma.co.id

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2026
• First Posted: September 17, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: September 17, 2026

Record last verified: 2026-09

Locations

ID (1)