Tolerability and Immunogenicity of Gardasil in Females Between 16 and 23 Years of Age in India (V501-034)

February 27, 2025 updated by: Merck Sharp & Dohme LLC

Evaluation of Tolerability and Immunogenicity of GARDASIL in Healthy Females, Between 16 and 26 Years of Age, in India.

This study is designed to determine the tolerability and immunogenicity of a 3-dose regimen of Gardasil administered to healthy married females between 16 and 23 years of age, in India.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 22 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy Married Females Between 16 And 23 Years Of Age With Intact Uteri
  • No Clinical Evidence Of Gross Purulent Cervicitis (Otherwise Postpone Until After Treatment Or Lack Of Laboratory Confirmation Of Treatable Cause
  • Must Agree To Refrain From Sexual Activity (Including Vaginal And Anal Penetration And Any Genital Contact) For 48 Hours Prior To Any Scheduled Visit That Includes A Pelvic Examination In An Attempt To Avoid Detection Of Viral DNA Which Has Been Deposited In The Vagina Or On The Perineal/Perianal Area During Sexual Intercourse And Is Not The Result Of Ongoing Infection
  • Not Pregnant Now (As Determined By A Serum Pregnancy Test Or Urine Pregnancy Test Sensitive To 25 IU/L hCG), And Must Agree To Use Effective Contraception Through Month 7 Of The Study
  • Must Agree To Provide Study Personnel With A Primary Telephone Number As Well As An Alternate Telephone Number For Follow-Up Purposes.
  • Individuals Who Have Had Sexual Intercourse In The 2 Weeks Prior To Enrollment Must Have Been Using Effective Contraception As Defined Above (Emergency Contraception Is Not Considered Effective Contraception For Enrollment Into The Study.)

Exclusion Criteria:

  • Individuals Concurrently Enrolled In Clinical Studies Of Investigational Agents Or Studies Involving Collection Of Cervical/Genital Specimens
  • Feverish Feeling Within 24 Hours Prior To The First Injection And No Temperature < 100°F Or < 37.8°C (Oral Or Oral Equivalent) At First Vaccination
  • History Of Recent Or Ongoing Alcohol Or Other Drug Abuse. Alcohol Abusers Are Defined As Those Who Drink Despite Recurrent Social, Interpersonal, And Legal Problems As A Result Of Alcohol Use
  • History Of Known Prior Vaccination With An Hpv Vaccine Subject Has Received Non-Replicating (Inactivated) Vaccine Within 14 Days Prior To The Day 1 Vaccination Or Has Received Replicating (Live Virus) Vaccine Within 21 Days Prior To The Day 1 Vaccination
  • Individuals With Any Prior Abnormal Pap Test Showing Squamous Intraepithelial Lesion (Sil), Ascus, Asc-Us, Asc-H Individuals With A History Of Genital Warts
  • Individuals Allergic To Any Vaccine Component, Including Aluminium, Yeast, Or Benzonase™ (Nuclease, Nycomed [Used To Remove Residual Nucleic Acids From This And Other Vaccines])
  • Individuals Who Have Received Any Immune Globulin Preparation Or Blood-Derived Products Within The 3 Months Prior To The First Injection, Or Plan To Receive Any Through The Completion Of The Study
  • Individuals With A History Of Splenectomy, Known Immune Disorders (E.G., Systemic Lupus Erythematosus, Rheumatoid Arthritis), Or Receiving Immunosuppressives (E.G., Substances Or Treatments Known To Diminish Immune Response Such As Radiation Therapy, Administration Of Antimetabolites, Antilymphocytic Sera, Systemic Corticosteroids)
  • Individuals Who Have Received Periodic Treatments With Immunosuppressives, Defined As At Least 3 Courses Of Systemic Corticosteroids Each Lasting At Least 1 Week In Duration For The Year Prior To Enrollment, Will Be Excluded. Subjects Using Topical Steroids (I.E., Inhaled Or Nasal) Will Be Eligible For Vaccination
  • Individuals Who Are Immunocompromised Or Have Been Diagnosed As Having HIV Infection
  • Individuals With Known Thrombocytopenia Or Any Coagulation Disorder That Would Contraindicate Intramuscular Injections
  • Any Condition Which In The Opinion Of The Investigator Might Interfere With The Evaluation Of The Study Objectives
  • Any Plans To Permanently Relocate From The Area Prior To The Completion Of The Study Or To Leave For An Extended Period Of Time When Study Visits Would Need To Be Scheduled
  • Inability To Give Consent/Assent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
GARDASIL, Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine 0.5 mL of GARDASIL as intramuscular injections at the Day 1, Month 2, and Month 6 visits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The percentage of subjects who seroconvert to each of HPV 6, 11, 16, 18 at Week 4 Post dose 3 (Month 7), Month 24 and Month 36.
Time Frame: Week 4 Post dose 3 (Month 7), Month 24 and Month 36
Week 4 Post dose 3 (Month 7), Month 24 and Month 36

Secondary Outcome Measures

Outcome Measure
Time Frame
The Geometric Mean Titers (GMTs)
Time Frame: Week 4 Post dose 3 (Month 7), Month 24 and Month 36
Week 4 Post dose 3 (Month 7), Month 24 and Month 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Monitor, Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2009

Primary Completion (Estimated)

October 1, 2013

Study Completion (Estimated)

October 1, 2013

Study Registration Dates

First Submitted

August 8, 2008

First Submitted That Met QC Criteria

August 11, 2008

First Posted (Estimated)

August 12, 2008

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 27, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V501-034
  • 2008_016 (Other Identifier: Merck Registration Number)
  • CTRI/2009/091/000787 (Registry Identifier: CTRI)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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