Clinical trial · Interventional
Safety and Immunogenicity of Extended 2-dose Regimens of 9-valent Human Papillomavirus (9vHPV) Vaccine (V503-069)
A Phase 3 International, Multicenter, Open-label Study to Evaluate the Safety and Immunogenicity of 9vHPV Vaccine Administered as 2-dose Regimen With Extended Dosing Intervals in 9- to 14-Year Old Boys and Girls Compared With a Standard 3-dose Regimen in 16- to 26-Year Old Women
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a 96-month safety and immunogenicity study conducted in boys and girls 9 to 14 years of age and in young women 16 to 26 years of age. From this study, the goal is to establish that the investigational extended 2-dose regimens (0, 12 months; 0, 24 months; 0, 36 months; and 0, 60 months) studied in boys and girls 9 to 14 years of age are generally safe and immunogenic, with an antibody response that is not inferior to that observed in young women 16 to 26 years of age who receive the standard 3-dose regimen of 9-valent human papillomavirus (9vHPV) vaccine at 0, 2, and 6 months (i.e., the population and dose regimen used to establish 9vHPV vaccine efficacy).
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 |
|---|---|---|---|
| Papillomavirus Infections | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 9vHPV vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Cohort 0: 1 Dose of 9vHPV Vaccine (previous 1-dose recipients)
- description
- 10 to 15 year old girls and boys (who previously received 1 dose of 9vHPV vaccine) receive a second dose of 9vHPV vaccine at Day 1.
- interventionNames
- Biological: 9vHPV vaccine
- type
- EXPERIMENTAL
- label
- Cohort 1: 2 Doses of 9vHPV Vaccine Given 12 Months Apart
- description
- 9 to 14 year old girls and boys receive a 2-dose regimen of 9vHPV vaccine at Day 1 and Month 12.
- interventionNames
- Biological: 9vHPV vaccine
- type
- EXPERIMENTAL
- label
- Cohort 2: 2 Doses of 9vHPV Vaccine Given 24 Months Apart
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 9 Years
- Maximum age
- 26 Years
Show eligibility criteria text
Inclusion Criteria: Boys and Girls 9 to 15 Years: \- Must not have had coitarche and does not plan on becoming sexually active during the vaccination period Women 16 to 26 Years: * Has never had a Papanicolaou (Pap) test or only had normal Pap test results * A lifetime history of 0 to 4 male and/or female sexual partners Cohort 0 Participants: \- Received 1 dose of 9vHPV vaccine at least 1 year prior to enrollment and did not receive a second dose of any HPV vaccine Exclusion Criteria: All Participants: * Known allergy to any vaccine component * History of severe allergic reaction that required medical intervention * Thrombocytopenia or any coagulation disorder * Females only: participant is pregnant or expecting to donate eggs during day 1 through month 7 * Currently immunocompromised, or been diagnosed with immunodeficiency * Had a splenectomy * Receiving or has received immunosuppressive therapies within the last year * Received any immunoglobulin product or blood-derived product within 3 months * Has received more than 1 dose of an HPV vaccine (Cohort 0) * Received a marketed HPV vaccine or has participated in an HPV vaccine clinical trial (Cohorts 1-5)
References
Publications (2)
- RESULTTeppler H, Bautista O; Thomas Group; Flores S, McCauley J, Luxembourg A. Design of a Phase III immunogenicity and safety study evaluating two-dose regimens of 9-valent human papillomavirus (9vHPV) vaccine with extended dosing intervals. Contemp Clin Trials. 2021 Jun;105:106403. doi: 10.1016/j.cct.2021.106403. Epub 2021 Apr 12. PMID 33857679
- RESULTKlein NP, Wiesner A, Bautista O, Group T, Kanu K, Li ZL, McCauley J, Saxena K, Tota J, Luxembourg A, Bonawitz R. Immunogenicity and Safety of Extended-Interval 2-Dose Regimens of 9vHPV Vaccine. Pediatrics. 2024 Aug 1;154(2):e2023064693. doi: 10.1542/peds.2023-064693. PMID 38978512