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

Papillomavirus Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00380367
• Other study ID #: V501-029
• Secondary ID: 2006_0382017-000
• Status: Completed
• Phase: Phase 3
• Start date: May 3, 2007
• Est. completion date: February 4, 2008

Study information

• Verified date: May 2023
• Source: Merck Sharp & Dohme LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: February 4, 2008
• Est. primary completion date: February 4, 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 9 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Papillomavirus Infections

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC

References & 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 Immunothe — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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