N/A
Completed N=903
Immunogenicity and Reactogenicity of Alternative Schedules of Gardasil
Dose Schedule Study
Source: ClinicalTrials.gov NCT00524745 ↗
Enrolled (actual)
903
Serious AEs
0.0%
Results posted
Sep 2011
Primary outcomePrimary: Comparison of Antibody Response to HPV Type 16 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule. — 0.93; 0.99; 0.63; 1.0 GMT ratio
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of Antibody Response to HPV Type 16 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule. |
0.93; 0.99; 0.63; 1.0 | — |
| PRIMARY Comparison of Antibody Response to HPV Type 18 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule. |
0.88; 0.92; 0.77; 1.0 | — |
| SECONDARY Comparison of Antibody Response to HPV Type 6 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule. |
1.07; 1.14; 0.64; 1.0 | — |
| SECONDARY Comparison of Antibody Response to HPV Type 11 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule. |
0.86; 0.86; 0.96; 1.0 | — |
Eligibility Criteria
Inclusion Criteria
- 11-13 years of age.
- Signed informed consent form (both parent's & daughter's signature).
- Good health status.
- Able to comply with trial protocol.
- Plans to stay at current school for duration of study.
Exclusion Criteria
- Prior HPV vaccination
- Pregnant or lactating or intends to become pregnant during study period.
- Apparent moderate or severe acute illness.
- Clinical history of bleeding disorder such as hemophilia, thrombocytopenia, or anticoagulant therapy.
- Clinical history of impaired immune responsiveness, whether due to use of immunosuppressive therapy, a genetic defect, HIV infection, or other causes.
- 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.
- Investigational drug or investigational vaccine administered during the period from 30 days before to 30 days after any dose of HPV vaccine.
Data sourced from ClinicalTrials.gov (NCT00524745). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.