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Immunogenicity and Reactogenicity of Alternative Schedules of Gardasil

This study has been completed.
Sponsor:
Collaborator:
National Institute of Hygiene and Epidemiology, Vietnam
Information provided by (Responsible Party):
Kathleen Neuzil, Program for Appropriate Technology in Health
ClinicalTrials.gov Identifier:
NCT00524745
First received: August 31, 2007
Last updated: July 2, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention
Dose Schedule Study
 Biological: Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Comparison of the Immunogenicity and Reactogenicity of Alternative Schedules of Gardasil Vaccine to Prevent HPV Infection

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Program for Appropriate Technology in Health:

Primary Outcome Measures:
  • Comparison of Antibody Response to HPV Type 16 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule. [ Time Frame: 25 months ] [ Designated as safety issue: No ]
  • Comparison of Antibody Response to HPV Type 18 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule. [ Time Frame: 25 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of Antibody Response to HPV Type 6 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule. [ Time Frame: 25 months ] [ Designated as safety issue: No ]
  • Comparison of Antibody Response to HPV Type 11 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule. [ Time Frame: 25 months ] [ Designated as safety issue: No ]

Enrollment: 903
Study Start Date: October 2007
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 0,2,6 month vaccination schedule 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.
Active Comparator: 0,3,9 month vaccination schedule 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.
Active Comparator: 0,6,12 month vaccination schedule 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.
Active Comparator: 0,12,24 month vaccination schedule 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.

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.

  Eligibility

Ages Eligible for Study:   11 Years to 13 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00524745

Locations
Vietnam
National Institute of Hygiene and Epidemiology
Hanoi, Vietnam
Sponsors and Collaborators
Program for Appropriate Technology in Health
National Institute of Hygiene and Epidemiology, Vietnam
Investigators
Principal Investigator: Kathy Neuzil, MD, MPH Program for Appropriate Technology in Health
  More Information

Publications:

Responsible Party: Kathleen Neuzil, Global Principal Investigator, Program for Appropriate Technology in Health
ClinicalTrials.gov Identifier: NCT00524745     History of Changes
Other Study ID Numbers: HPV01
Study First Received: August 31, 2007
Results First Received: August 3, 2011
Last Updated: July 2, 2012
Health Authority: United States: Institutional Review Board
Vietnam: Ministry of Health
Vietnam: National Institute of Hygiene and Epidemiology (NIHE) Institutional Review Board

Keywords provided by Program for Appropriate Technology in Health:
Gardasil
Human Papillomavirus
HPV vaccine
Cervical cancer

ClinicalTrials.gov processed this record on May 23, 2013