V501 (Gardasil) Study in Preadolescent Females - Full Text View

Purpose

The study evaluates the immunogenicity, safety and tolerability of v501 in preadolescent females.

Condition	Intervention	Phase
Papillomavirus Infections	Biological: human papillomavirus (types 6,11,16,18) recombinant vaccine Biological: Comparator: placebo (unspecified)	Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	V501 (Gardasil) Phase II Immunogenicity Study in Females Aged 9 to 17 Years

Further study details as provided by Merck:

Primary Outcome Measures:

HPV 6, 11, 16 and 18 serum antibody title at one month after completed vaccination series [ Time Frame: At one month after completed vaccination series ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety Profile [ Time Frame: Duration of Treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	December 2006
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator 1. Placebo	Biological: Comparator: placebo (unspecified) Placebo 0..5 ml injection in 3 dosing regimen
2: Experimental V501	Biological: human papillomavirus (types 6,11,16,18) recombinant vaccine V501; Gardasil, 0.5 ml injection in 3 dosing regimen

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00411749

Sponsors and Collaborators

Merck

Investigators


Study Director:	Medical Monitor	Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2006_052, V501-028
First Received:	December 14, 2006
Last Updated:	September 8, 2008
ClinicalTrials.gov Identifier:	NCT00411749
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Merck:

HPV

Study placed in the following topic categories:

Virus Diseases

DNA Virus Infections

Papillomavirus Infections

Additional relevant MeSH terms:

Tumor Virus Infections

Infection

ClinicalTrials.gov processed this record on October 15, 2008

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00411749