A Phase 3 interventional study of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine and Tetanus-Diphtheria booster in Human Papillomavirus (HPV) Infection, sponsored by PT Bio Farma. Not yet recruiting at 1 site in Indonesia. Open to participants aged 9 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by PT Bio Farma · Phase 3, Interventional, and Prevention
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.
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.
576 studies on the registry are indexed under Papillomavirus Infections; 132 are open to participants now.
This study's planned enrollment of 266 is above the median of 235 across 402 interventional studies indexed under Papillomavirus Infections.
Browse Papillomavirus Infections studies →PT Bio Farma is the lead sponsor of 47 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
7. Abnormality/chronic disease interfering with objectives; 8. History of HPV/diphtheria/tetanus infection; 9. Previous HPV vaccination.
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
Participants receive a single dose of quadrivalent HPV vaccine alone.
Biological: 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.
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
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.
Time frame: 28 days after vaccination
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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