Safety, Tolerability and Immunogenicity of HPV (Human Papilloma Virus) Vaccine in Healthy Females 9 to 15 Years of Age in India (V501-029)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00380367
First received: September 22, 2006
Last updated: June 17, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to evaluate the safety and tolerability of the Quadrivalent HPV vaccine in healthy females 9 to 15 years of age in India.


Condition Intervention Phase
Papillomavirus Infections
Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of Safety, Tolerability and Immunogenicity of Quadrivalent HPV Vaccine in Healthy Females 9 to 15 Years of Age in India

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Percentage of Subjects Who Serologically Convert to Each of Human Papilloma Virus (HPV) 6, 11, 16, 18 at Week 4 Postdose 3 (Month 7) [ Time Frame: 7 months ] [ Designated as safety issue: No ]
    Month 7 HPV cLIA seroconversion rates among subjects who received Quadrivalent Human Papilloma Virus (HPV) (Types 6, 11, 16, 18) L 1 VLP vaccine (per‐protocol immunogenicity population ).


Secondary Outcome Measures:
  • Injection Site Adverse Experiences (AE), and Any Adverse Experiences (AE) That Occur Throughout the Study [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]

Enrollment: 110
Study Start Date: May 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
V501
Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
Quadrivalent HPV vaccine (6,11,16,18) given on day 1, month 2 & month 6, 7 months of treatment

  Eligibility

Ages Eligible for Study:   9 Years to 15 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy Females Age 9 To 15 Years
  • Females Not Sexually Active And Not Plan On Becoming Sexually Active During The Study
  • No Fevers 24 Hours Prior To The First Injection

Exclusion Criteria:

  • Subject Had Received A Prior Vaccination With A HPV Vaccine
  • Subject Has Allergies To Vaccine Component Including Aluminum And Yeast
  • Subject Has (Human Immunodeficiency Virus) HIV Infection
  • Subject Is Immunocompromised
  • Subject Received Or Plans To Receive Blood-Derived Product Within 6 Months Prior To The First Injection
  • Subject Received Or Plans To Receive Immune Globulin Preparation Within 6 Months To The First Injection
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00380367

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00380367     History of Changes
Other Study ID Numbers: V501-029, 2006_038
Study First Received: September 22, 2006
Results First Received: January 22, 2009
Last Updated: June 17, 2014
Health Authority: India: Ministry of Health

Additional relevant MeSH terms:
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections

ClinicalTrials.gov processed this record on July 22, 2014