Immunogenicity and Reactogenicity of Alternative Schedules of Gardasil

PATH

Status: Completed

Conditions: Dose Schedule Study

Treatments: Biological: Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT00524745

HPV01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 903 patients

Sex: Female

Ages: 11 to 13 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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903 participants in 4 patient groups

0,2,6 month vaccination schedule

Active Comparator group

Treatment:

Biological: Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine

0,3,9 month vaccination schedule

Active Comparator group

Treatment:

Biological: Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine

0,6,12 month vaccination schedule

Active Comparator group

Treatment:

Biological: Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine

0,12,24 month vaccination schedule

Active Comparator group

Treatment:

Biological: Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine