HPV01

About this trial

Last updated 8 years ago

Study ID

HPV01

Status

Completed

Type

Interventional

Phase

N/A

Placebo

Accepting

11 to 13 Years

Female

Trial Timing

Ended 15 years ago

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.

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.

Immunogenicity and Reactogenicity of Alternative Schedules of Gardasil