Clinical trial · Interventional
A Phase III Study of a 2-dose Regimen of a Multivalent Human Papillomavirus (HPV) Vaccine (V503), Administered to 9 to 14 Year-olds and Compared to Young Women, 16 to 26 Years Old (V503-010)
A Phase III Clinical Trial to Study the Tolerability and Immunogenicity of a 2-dose Regimen of V503, a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, Administered in Preadolescents and Adolescents (9 to 14 Year Olds) With a Comparison to Young Women (16 to 26 Year Olds)
- 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 was a 37-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 was to establish that the investigational 2-dose regimens (0, 6 months and 0, 12 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 received the standard 3-dose regimen of V503 (i.e., the population and dose regimen used to establish V503 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 |
|---|---|---|---|
| Human Papillomavirus Infection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| V503 (9-valent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] vaccine) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Girls 9 to 14 Years V503 at Months 0 and 6
- description
- Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
- interventionNames
- Biological: V503 (9-valent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] vaccine)
- type
- EXPERIMENTAL
- label
- Boys 9 to 14 Years V503 at Months 0 and 6
- description
- Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
- interventionNames
- Biological: V503 (9-valent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] vaccine)
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 9 Years
- Maximum age
- 26 Years
Show eligibility criteria text
Inclusion Criteria: All Participants: -Judged to be in good physical health on the basis of medical history, physical examination and laboratory results Boys and Girls 9 to 14 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 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 * Received a marketed HPV vaccine or has participated in an HPV vaccine clinical trial
References
Publications (3)
- RESULTIversen OE, Miranda MJ, Ulied A, Soerdal T, Lazarus E, Chokephaibulkit K, Block SL, Skrivanek A, Nur Azurah AG, Fong SM, Dvorak V, Kim KH, Cestero RM, Berkovitch M, Ceyhan M, Ellison MC, Ritter MA, Yuan SS, DiNubile MJ, Saah AJ, Luxembourg A. Immunogenicity of the 9-Valent HPV Vaccine Using 2-Dose Regimens in Girls and Boys vs a 3-Dose Regimen in Women. JAMA. 2016 Dec 13;316(22):2411-2421. doi: 10.1001/jama.2016.17615. PMID 27893068
- DERIVEDCarter JJ, Smith RA, Scherer EM, Skibinski DAG, Sankaranarayanan S, Luxembourg A, Kollmann T, Marty KD, Sadarangani M, Dobson S, Galloway DA. Term immune memory responses to human papillomavirus (HPV) vaccination following 2 versus 3 doses of HPV vaccine. Vaccine. 2025 Mar 19;50:126817. doi: 10.1016/j.vaccine.2025.126817. Epub 2025 Feb 5. PMID 39914257
- DERIVEDBornstein J, Roux S, Kjeld Petersen L, Huang LM, Dobson SR, Pitisuttithum P, Diez-Domingo J, Schilling A, Ariffin H, Tytus R, Rupp R, Senders S, Engel E, Ferris D, Kim YJ, Tae Kim Y, Kurugol Z, Bautista O, Nolan KM, Sankaranarayanan S, Saah A, Luxembourg A. Three-Year Follow-up of 2-Dose Versus 3-Dose HPV Vaccine. Pediatrics. 2021 Jan;147(1):e20194035. doi: 10.1542/peds.2019-4035. Epub 2020 Dec 22. PMID 33386332