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

NCT00380367 | Completed Phase 3 Results

• 3 other identifiers: V501-0292006_0382017-000111-16
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Papillomavirus Infections

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Who Seroconvert to Each HPV Serotype (Types 6, 11, 16, 18) at 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

  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

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

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

Quadrivalent HPV vaccine (6, 11, 16, 18) given intramuscularly on Day 1, Month 2, and Month 6.

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

Eligibility Criteria

• Age: 9 Years - 15 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Garland SM, Anagani M, Bhatla N, Chatterjee S, Lalwani S, Ross C, Group T, Lin J, Luxembourg A, Walia A, Tu Y. Immunogenicity and safety of quadrivalent and 9-valent human papillomavirus vaccines in Indian clinical trial participants. Hum Vaccin Immunother. 2022 Nov 30;18(6):2105067. doi: 10.1080/21645515.2022.2105067. Epub 2022 Aug 23.

  PMID: 35997582 RESULT

MeSH Terms

Conditions

Papillomavirus Infections

Interventions

Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Papillomavirus Vaccines; Viral Vaccines

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2006
• First Posted: September 26, 2006
• Study Start: May 3, 2007
• Primary Completion: February 4, 2008
• Study Completion: February 4, 2008
• Last Updated: May 31, 2023
• Results First Posted: April 14, 2009

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share