NCT00524745

Immunogenicity and Reactogenicity of Alternative Schedules of Gardasil

Comparison of the Immunogenicity and Reactogenicity of Alternative Schedules of Gardasil Vaccine to Prevent HPV Infection

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 903 (actual)
• Sponsor: PATH · Academic / Other
• Sex: Female
• Age: 11 Years – 13 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dose Schedule Study

Interventions

Type	Name	Description
BIOLOGICAL	Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine	Three doses of quadrivalent HPV recombinant vaccine administered at different dosing intervals in each of four study arms.

Timeline

• Start date: 2007-10-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2007-09-05
• Last updated: 2017-04-14
• Results posted: 2011-09-08

Locations

1 site across 1 country: Vietnam