Clinical trial · Interventional
Immunogenicity and Safety of HPV-4 Vaccine With or Without Td Vaccine in Children
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 18, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260918-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Human Papillomavirus (HPV) Infection | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine | Biological | — | UNRESOLVED |
| Tetanus-Diphtheria booster | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 4vHPV + Td vaccine
- description
- Participants receive a single dose of quadrivalent HPV vaccine co-administered with Td vaccine.
- interventionNames
- Biological: Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine
- Biological: Tetanus-Diphtheria booster
- type
- ACTIVE_COMPARATOR
- label
- 4vHPV alone
- description
- Participants receive a single dose of quadrivalent HPV vaccine alone.
- interventionNames
- Biological: Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine
Primary outcomes (1)
- measure
- Number and percentage of subjects seroconverted for anti-HPV types 6, 11, 16, and 18
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 9 Years
- Maximum age
- 15 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 9-15 years; 2. Healthy; 3. Subject/parent or LAR appropriately informed and consent/assent signed; 4. Willing to comply with investigator instructions and study schedule. Exclusion Criteria: 1. Concurrent/other trial; 2. Evolving illness/fever ≥37.5°C; 3. Allergy to vaccine components; 4. Uncontrolled coagulopathy/blood disorder contraindicating IM injection; 5. 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.
References
Publications (0)
Data not yet available