Clinical trial · Interventional
Immunogenicity and Reactogenicity of Alternative Schedules of Gardasil
Comparison of the Immunogenicity and Reactogenicity of Alternative Schedules of Gardasil Vaccine to Prevent HPV Infection
NCT00524745CI-TRIAL-00026988completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
To demonstrate that Gardasil® vaccine, when given to girls 11-13 years of age according to 1 of 3 alternative 3-dose schedules (0, 3, 9 months; 0, 6, 12 months; or 0, 12, 24 months), results in anti-HPV type 16 and anti-HPV type 18 responses 28 days post-dose 3 that are similar to those obtained when the vaccine is given on the standard 3-dose schedule of 0, 2, 6 months.
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 |
|---|---|---|---|
| Dose Schedule Study | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- 0,2,6 month vaccination schedule
- interventionNames
- Biological: Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
- type
- ACTIVE_COMPARATOR
- label
- 0,3,9 month vaccination schedule
- interventionNames
- Biological: Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
- type
- ACTIVE_COMPARATOR
- label
- 0,6,12 month vaccination schedule
- interventionNames
- Biological: Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 11 Years
- Maximum age
- 13 Years
Show eligibility criteria text
Inclusion Criteria: 1. 11-13 years of age. 2. Signed informed consent form (both parent's \& daughter's signature). 3. Good health status. 4. Able to comply with trial protocol. 5. Plans to stay at current school for duration of study. Exclusion Criteria: 1. Prior HPV vaccination 2. Pregnant or lactating or intends to become pregnant during study period. 3. Apparent moderate or severe acute illness. 4. Clinical history of bleeding disorder such as hemophilia, thrombocytopenia, or anticoagulant therapy. 5. Clinical history of impaired immune responsiveness, whether due to use of immunosuppressive therapy, a genetic defect, HIV infection, or other causes. 6. Hypersensitivity to the active substances or to any of the excipients of the HPV vaccine, or such reactions to other vaccines received in the past. 7. Investigational drug or investigational vaccine administered during the period from 30 days before to 30 days after any dose of HPV vaccine.
References
Publications (3)
- RESULTNeuzil KM, Canh DG, Thiem VD, Janmohamed A, Huong VM, Tang Y, Diep NT, Tsu V, LaMontagne DS. Immunogenicity and reactogenicity of alternative schedules of HPV vaccine in Vietnam: a cluster randomized noninferiority trial. JAMA. 2011 Apr 13;305(14):1424-31. doi: 10.1001/jama.2011.407. PMID 21486975
- DERIVEDWiddice LE, Unger ER, Panicker G, Hoagland R, Callahan ST, Jackson LA, Berry AA, Kotloff K, Frey SE, Harrison CJ, Pahud BA, Edwards KM, Mulligan MJ, Sudman J, Bernstein DI. Antibody responses among adolescent females receiving two or three quadrivalent human papillomavirus vaccine doses at standard and prolonged intervals. Vaccine. 2018 Feb 1;36(6):881-889. doi: 10.1016/j.vaccine.2017.12.042. Epub 2018 Jan 3. PMID 29306506
- DERIVEDLamontagne DS, Thiem VD, Huong VM, Tang Y, Neuzil KM. Immunogenicity of quadrivalent HPV vaccine among girls 11 to 13 Years of age vaccinated using alternative dosing schedules: results 29 to 32 months after third dose. J Infect Dis. 2013 Oct 15;208(8):1325-34. doi: 10.1093/infdis/jit363. Epub 2013 Jul 30. PMID 23901077