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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00520598
Other study ID # V505-001
Secondary ID 2007_567
Status Completed
Phase Phase 2
First received August 22, 2007
Last updated November 25, 2015
Start date October 2007
Est. completion date May 2011

Study information

Verified date November 2015
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority Australia: National Health and Medical Research Council
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and immunogenicity of V505 in comparison to GARDASIL (TM)


Recruitment information / eligibility

Status Completed
Enrollment 511
Est. completion date May 2011
Est. primary completion date May 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 16 Years to 26 Years
Eligibility Inclusion Criteria:

- Female between 16 to 26 years old

- Has never had Pap testing or have only had normal Pap test results

- Lifetime history of 0 to 4 sexual partners

Exclusion Criteria:

- History of an abnormal cervical biopsy result; History of a positive test for HPV; History of external genital/vaginal warts; Currently a user of any illegal drugs or an alcohol abuser

- History of severe allergic reaction that required medical attention

- Are pregnant

- Received a marketed HPV vaccine

- Currently enrolled in a clinical trial

- Currently has (or has a history of) certain medical conditions or is currently taking or has taken certain medications (details will be discussed at time of consent)

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Intervention

Biological:
Comparator: V505 formulation 1
0.5 ml injection of V505 formulation 1 as 3 dose regimen at Day 1, Month 2 and Month 6.
Drug:
Comparator: V505 formulation 2
0.5 ml injection of V505 formulation 2 as 3 dose regimen at Day 1, Month 2 and Month 6.
Comparator: V505 formulation 2
0.5 ml injection of V505 formulation 2 as 2 dose regimen at Day 1 and Month 6.
Biological:
Comparator: V505 formulation 3
0.5 ml injection of V505 formulation 3 as 2 dose regimen at Day 1 and Month 6.
Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant
0.5 ml injection of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine as 3 dose regimen at Day 1, Month 2 and Month 6.
Comparator: Placebo (unspecified)
0.5 ml injection of placebo to V505 as a 1 dose regimen at Month 2.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type Measure Description Time frame Safety issue
Primary Geometric mean titers (GMTs) to HPV types contained in the vaccines administered in a 3-dose regimen 4 weeks post dose 3 No
Secondary Geometric mean titers (GMTs) to HPV types contained in the vaccines administered in a 2-dose regimen 4 weeks post dose 2 No
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