Immunogenicity and Reactogenicity of Alternative Schedules of Gardasil
- Conditions
- Dose Schedule Study
- Registration Number
- NCT00524745
- Lead Sponsor
- PATH
- Brief 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.
- Detailed Description
OBJECTIVES:
Primary objective:
To test the hypothesis that Gardasil® vaccine, when administered 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 16 and anti-HPV 18 responses 28 days post-dose 3 that are similar to those obtained when the vaccine is administered on the standard 3-dose schedule of 0,2,6 months.
Secondary objectives:
1. To test the hypothesis that Gardasil® vaccine, when administered 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 6 and anti-HPV 11 responses 28 days post-dose 3 that are similar to those obtained when the vaccine is administered on the standard 3-dose schedule of 0,2,6 months.
2. To describe the safety profile of the administration of Gardasil® according to each of the four schedules by assessing:
(i) immediate reactogenicity (reactions within 30 minutes after each injection); (ii) solicited (local reactogenicity and fever) and unsolicited events occurring during the first 7 days following each vaccination; (iii) serious adverse events occurring up to one month following the last dose of vaccine; (iv) deaths or adverse events occurring at any time determined to be vaccination-related.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 903
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Comparison of Antibody Response to HPV Type 16 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule. 25 months Comparison of Antibody Response to HPV Type 18 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule. 25 months
- Secondary Outcome Measures
Name Time Method Comparison of Antibody Response to HPV Type 11 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule. 25 months Comparison of Antibody Response to HPV Type 6 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule. 25 months
Trial Locations
- Locations (1)
National Institute of Hygiene and Epidemiology
🇻🇳Hanoi, Vietnam