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

May 2, 2023 updated by: Merck Sharp & Dohme LLC

Evaluation of Safety, Tolerability and Immunogenicity of Quadrivalent HPV Vaccine in Healthy Females 9 to 15 Years of Age in India

The purpose of this study is to evaluate the safety and tolerability of the Quadrivalent Human Papilloma Virus (HPV) vaccine in healthy females 9 to 15 years of age in India. Quadrivalent HPV Vaccine is composed of L1 virus-like particles (VLPs) from HPV types 6, 11, 16, and 18.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

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

9 years to 15 years (Child)

Accepts Healthy Volunteers

Yes

Description

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:

  • Participant Had Received A Prior Vaccination With A HPV Vaccine
  • Participant Has Allergies To Vaccine Component Including Aluminum And Yeast
  • Participant Has (Human Immunodeficiency Virus) HIV Infection
  • Participant Is Immunocompromised
  • Participant Received Or Plans To Receive Blood-Derived Product Within 6 Months Prior To The First Injection
  • Participant Received Or Plans To Receive Immune Globulin Preparation Within 6 Months To The First Injection

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Quadrivalent HPV VLP Vaccine (Types 6, 11, 16, 18)
Participants who enroll receive a total of 3 intramuscular injections of Quadrivalent HPV VLP vaccine (types 6, 11, 16, 18) given on Day 1, Month 2 and Month 6.
Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
Quadrivalent HPV vaccine (6, 11, 16, 18) given intramuscularly on Day 1, Month 2, and Month 6.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Seroconvert to Each HPV Serotype (Types 6, 11, 16, 18) at Month 7
Time Frame: One month post-dose 3 (Month 7)
Month 7 HPV competitive Luminex Immunoassay (cLIA) seroconversion rates among participants who received Quadrivalent HPV (Types 6, 11, 16, 18) Late 1 (L1) capsid protein VLP vaccine were reported. The quadrivalent HPV competitive cLIA (v2.0) was used to detect antibody to HPV VLPs serotypes 6, 11, 16, 18 before and after vaccination with the HPV quadrivalent vaccine. Seropositivity cutoffs of the HPV cLIAs were assessed using a panel of sera from participants highly likely to be HPV naïve (children), and from participants who were highly likely to be seropositive. Any sample with a value less than the cutoffs was considered serostatus negative. Samples with values equal to or greater than the cutoff were considered serostatus positive. The cutoffs for the HPV 6, 11, 16, and 18 cLIAs were 20 milli-Merck units per milli liter (mMU/mL), 16 mMU/mL, 20 mMU/mL, and 24 mMU/mL, respectively.
One month post-dose 3 (Month 7)
Number of Participants With Any Adverse Events (AEs), Injection-site AEs, Systemic AEs, or Vaccine-related AEs During the Study
Time Frame: Up to 7 months

An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the SPONSOR's product, was also an AE. Pre-specified injection site AEs included pain, tenderness, erythema, and swelling. A vaccine-related AE was an AE considered by the investigator to be possibly, probably, or definitely related to the vaccine. All AEs collected on participant's Vaccination Report Card daily for 14 days after each vaccination (Days 1-15).

The number of participants who experienced ≥1 AE, the number of participants who experienced ≥1 injection site AE, the number of participants who experienced ≥1 systemic AE, and the number of participants who experienced ≥1 vaccine-related AE were reported for the Safety Cohort.
Up to 7 months

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 Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

May 3, 2007

Primary Completion (Actual)

February 4, 2008

Study Completion (Actual)

February 4, 2008

Study Registration Dates

First Submitted

September 22, 2006

First Submitted That Met QC Criteria

September 22, 2006

First Posted (Estimated)

September 26, 2006

Study Record Updates

Last Update Posted (Actual)

May 31, 2023

Last Update Submitted That Met QC Criteria

May 2, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V501-029
  • 2006_038 (Other Identifier: Merck Registration Number)
  • 2017-000111-16 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

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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