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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Papillomavirus Infections

Treatments: Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00380367

2006_038 (Other Identifier)

2017-000111-16 (EudraCT Number)

V501-029

Details and patient eligibility

About

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.

Enrollment: 110 patients

Sex: Female

Ages: 9 to 15 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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110 participants in 1 patient group

Quadrivalent HPV VLP Vaccine (Types 6, 11, 16, 18)

Experimental group

Description:

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.

Treatment:

Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine