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Immunogenicity and Safety of HPV-4 Vaccine With or Without Td Vaccine in Children
Sponsor: PT Bio Farma
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.
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
Key Details
Gender
All
Age Range
9 Years - 15 Years
Study Type
INTERVENTIONAL
Enrollment
266
Start Date
2026-10
Completion Date
2027-01-31
Last Updated
2026-09-17
Healthy Volunteers
Yes
Conditions
Interventions
Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine
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 booster
A single 0.5 mL dose of Adsorbed Td (Tetanus-Diphtheria Toxoid) Vaccine Bio Farma containing purified tetanus toxoid and purified diphtheria toxoid.
Locations (1)
RSUD Dr. Soetomo
Surabaya, East Java, Indonesia