Study of Human Papillomavirus (HPV) 16 Vaccine in the Prevention of HPV 16 Infection in 16- to 23-Year-Old Females - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00365378

Purpose

Subjects received HPV 16 L1 VLP vaccine or placebo (1:1 ratio). Endpoints included efficacy, immunogenicity, and safety.

Condition	Intervention	Phase
HPV 16 Infection	Biological: Comparator: HPV 16 L1 Vaccine Biological: Comparator: Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
Official Title:	Study of Pilot Manufacturing Lot of HPV 16 Virus-Like Particle (VLP) Vaccine in the Prevention of HPV 16 Infection in 16- to 23-Year-Old Females

Further study details as provided by Merck:

Primary Outcome Measures:

Incidence of Persistent HPV 16 Infection [ Time Frame: Through Month 48 ] [ Designated as safety issue: No ]
Cases of persistent infection were those with detection of HPV 16 by PCR (Polymerase chain reaction) on at least 2 consecutive visits at least 4 months apart; or detection of HPV 16 in a cervical biopsy specimen showing pathologic evidence of CIN1 (Cervical intraepithelial neoplasia), CIN2 or CIN3 together with HPV 16 detected at the visit immediately before or after the biopsy; or detection of HPV 16 on a subject's last visit.
Incidence of HPV 16-related CIN1, CIN2 or C1N3 [ Time Frame: Through Month 48 ] [ Designated as safety issue: No ]
Cases of HPV 16-related CIN1, CIN2 or CIN3 are those with detection of HPV 16 in a cervical biopsy specimen showing pathologic evidence of CIN1, CIN2 or CIN3 together with HPV 16 detected at the visit immediately before or after the biopsy.
Serum Anti-HPV 16 Geometric Mean Titers [ Time Frame: Month 7 ] [ Designated as safety issue: No ]
The limit of detection of the assay was 6 mMU/ml. Samples with titer below the limit of detection were assigned a value of 3 for calculation of GMT and confidence interval. GMTs and confidence limits below the limit of detection are shown as "6.0".

Enrollment:	2409
Study Start Date:	October 1998
Study Completion Date:	July 2009
Primary Completion Date:	March 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 HPV 16 L1 VLP vaccine	Biological: Comparator: HPV 16 L1 Vaccine A 0.5 intramuscular injection given at Day 1, Month 2, and Month 6 Other Name: V501
Placebo Comparator: 2 Placebo	Biological: Comparator: Placebo A 0.5 intramuscular placebo injection given at Day 1, Month 2, and Month 6

Eligibility

Criteria

Inclusion Criteria:

Healthy, unmarried females age 16 to 23 years with intact uteri
Not pregnant at enrollment
Agreed to use effective contraception through Month 7 of the study
A lifetime history of 0 to 5 male partners with whom the subjects engaged in at least one episode of insertive intercourse

Exclusion Criteria:

No prior history of Human Papillomavirus (HPV) vaccination
No receipt of any other vaccination within 1 month prior to enrollment or plans to receive any other vaccination within 1 month prior to or after any dose of study vaccine
No prior history of an abnormal Papanicolaou (Pap) test showing Squamous intraepithelial lesion (SIL) or biopsy showing Cervical intraepithelial neoplasia (CIN)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00365378

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00365378 History of Changes
Other Study ID Numbers:	2006_515, V501-005
Study First Received:	August 16, 2006
Results First Received:	March 22, 2010
Last Updated:	April 20, 2010
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on February 09, 2012