Broad Spectrum HPV Vaccine Dose Ranging Study (V502-001)

NCT ID: NCT00260039

Last Updated: 2015-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 680 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-31
• Study Completion Date: 2007-08-31

Brief Summary

This dose-ranging study is to evaluate an investigational vaccine with the following objectives: (1) To demonstrate that the vaccine is well-tolerated in women (2) To evaluate immune responses in women who are between 16 and 23 years of age at enrollment.

Conditions

HPV; Cervical Cancer; Premalignancy Anogenital Warts

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

1

Gardasil

Group Type: ACTIVE_COMPARATOR

Comparator: Gardasil

Intervention Type: BIOLOGICAL

0.5 mL intramuscular injection administered at Day 1, Month 2 and Month 6

2

HPV VLP vaccine -Dose regimen 1

Group Type: EXPERIMENTAL

Comparator: octavalent HPV Vaccine - dose formulation 1

Intervention Type: BIOLOGICAL

0.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6

3

HPV VLP vaccine -Dose regimen 2

Group Type: EXPERIMENTAL

Comparator: octavalent HPV Vaccine - dose formulation 2

Intervention Type: BIOLOGICAL

0.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6

4

HPV VLP vaccine -Dose regimen 3

Group Type: EXPERIMENTAL

Comparator: octavalent HPV Vaccine - dose formulation 3

Intervention Type: BIOLOGICAL

0.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6

Interventions

Comparator: Gardasil

0.5 mL intramuscular injection administered at Day 1, Month 2 and Month 6

Intervention Type: BIOLOGICAL

Comparator: octavalent HPV Vaccine - dose formulation 1

0.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6

Intervention Type: BIOLOGICAL

Comparator: octavalent HPV Vaccine - dose formulation 2

0.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6

Intervention Type: BIOLOGICAL

Comparator: octavalent HPV Vaccine - dose formulation 3

0.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Lifetime history of 0-4 sexual partners

Exclusion Criteria

• History of abnormal PAP test or abnormal cervical biopsy result; history of external genital/vaginal warts; history of positive HPV test

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 23 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Luxembourg A, Brown D, Bouchard C, Giuliano AR, Iversen OE, Joura EA, Penny ME, Restrepo JA, Romaguera J, Maansson R, Moeller E, Ritter M, Chen J. Phase II studies to select the formulation of a multivalent HPV L1 virus-like particle (VLP) vaccine. Hum Vaccin Immunother. 2015;11(6):1313-22. doi: 10.1080/21645515.2015.1012010.

Reference Type: BACKGROUND

PMID: 25912208 (View on PubMed)

Other Identifiers

2005_086

Identifier Type: -

Identifier Source: secondary_id

V502-001

Identifier Type: -

Identifier Source: org_study_id