Immunogenicity and Reactogenicity of Alternative Schedules of Gardasil

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:

• 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.
• 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

• 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.