Comparison of the Immunogenicity and Reactogenicity of Alternative Schedules of Gardasil Vaccine to Prevent HPV Infection
11 Years
13 Years
Female
Dose Schedule Study
Trial Information
Comparison of the Immunogenicity and Reactogenicity of Alternative Schedules of Gardasil Vaccine to Prevent HPV Infection
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Comparison of Antibody Response to HPV Type 16 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule.
Outcome Time Frame:
25 months
Safety Issue:
No
Principal Investigator
Kathy Neuzil, MD, MPH
Investigator Role:
Principal Investigator
Investigator Affiliation:
Program for Appropriate Technology in Health
Authority:
United States: Institutional Review Board
Study ID:
HPV01
NCT ID:
NCT00524745
Start Date:
October 2007
Completion Date:
January 2010
Related Keywords:
- Dose Schedule Study
- Gardasil
- Human Papillomavirus
- HPV vaccine
- Cervical cancer
Name | Location |
|---|
