Immune Response & Safety of a Hepatitis A Vaccine Given Together With a Pneumococcal Vaccine in Healthy Children 15 m of Age

NCT ID: NCT00197002

Last Updated: 2018-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 521 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-09-11
• Study Completion Date: 2006-01-16

Brief Summary

This is a study to evaluate the immunogenicity and safety of GSK Biologicals 2-dose inactivated hepatitis A vaccine when administered with a pneumococcal conjugate vaccine in children as young as 15 months of age.

Detailed Description

An open, controlled comparison of Havrix administered alone or with Prevnar. The three groups evaluated are: 1) Havrix alone, 2) Havrix plus Prevnar and 3) Prevnar followed by Havrix one month later.

Conditions

Hepatitis A

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Havrix Group

Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.

Group Type: ACTIVE_COMPARATOR

GSK Biologicals 2-dose inactivated hepatitis A vaccine (Havrix)

Intervention Type: BIOLOGICAL

Two doses, administered intramuscularly in the right anterolateral thigh.

Havrix+Prevnar Group

Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.

Group Type: EXPERIMENTAL

GSK Biologicals 2-dose inactivated hepatitis A vaccine (Havrix)

Intervention Type: BIOLOGICAL

Two doses, administered intramuscularly in the right anterolateral thigh.

Prevnar™

Intervention Type: BIOLOGICAL

One dose, administered intramuscularly in the left anterolateral thigh.

Prevnar Havrix Group

Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.

Group Type: ACTIVE_COMPARATOR

GSK Biologicals 2-dose inactivated hepatitis A vaccine (Havrix)

Intervention Type: BIOLOGICAL

Two doses, administered intramuscularly in the right anterolateral thigh.

Prevnar™

Intervention Type: BIOLOGICAL

One dose, administered intramuscularly in the left anterolateral thigh.

Interventions

GSK Biologicals 2-dose inactivated hepatitis A vaccine (Havrix)

Two doses, administered intramuscularly in the right anterolateral thigh.

Intervention Type: BIOLOGICAL

Prevnar™

One dose, administered intramuscularly in the left anterolateral thigh.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• A male or female child 12 or 13 months of age at the time of entry into the Enrollment Phase,
• Free of obvious health problems,
• Subjects must have previously received three doses of Prevnar in his/her first year of life.

Exclusion Criteria

• Use of any investigational or non-registered drug or vaccine within 42 days preceding the first dose of study vaccine, or planned use during the study period,
• Chronic administration of immuno-suppressant or other immune-modifying drugs within six months prior to vaccination or planned administration at any time during the study period. (For corticosteroids, this will mean prednisone, or equivalent, less than 0.5 mg/kg/day. Inhaled, nasal and topical steroids are allowed.),
• Administration of the ACIP-recommended fourth dose of Prevnar prior to entering the Enrollment Phase of the study,
• Planned administration or administration of any vaccine not foreseen by the study protocol within the period of 42 days before and 30 days after each dose of study vaccine(s),
• Previous vaccination against hepatitis A,
• History of hepatitis A or known exposure to hepatitis A,
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection,
• A family history of congenital, hereditary or infectious immunodeficiency or parental risk factors for HIV infection,
• History of allergic disease/reactions or hypersensitivity likely to be exacerbated by any component of Havrix (e.g., neomycin, 2-phenoxyethanol) or Prevnar (e.g., diphtheria toxoid),
• Major congenital defects or serious chronic illness,
• History of any neurologic disorder (history of febrile seizures not associated with an underlying neurological disorder does not exclude the subject),
• Acute disease, defined as the presence of a moderate or severe illness with or without fever, at the time of vaccination,
• Administration of immunoglobulins and/or any blood products within three months prior to the first dose of study vaccine or planned administration at any time during the entire study period.

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 13 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Centennial, Colorado, United States

GSK Investigational Site

Bardstown, Kentucky, United States

GSK Investigational Site

Louisville, Kentucky, United States

GSK Investigational Site

Boston, Massachusetts, United States

GSK Investigational Site

Boston, Massachusetts, United States

GSK Investigational Site

Kalamazoo, Michigan, United States

GSK Investigational Site

Omaha, Nebraska, United States

GSK Investigational Site

Las Vegas, Nevada, United States

GSK Investigational Site

North Las Vegas, Nevada, United States

GSK Investigational Site

Stony Brook, New York, United States

GSK Investigational Site

Chapel Hill, North Carolina, United States

GSK Investigational Site

University Heights, Ohio, United States

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

GSK Investigational Site

Dallas, Texas, United States

GSK Investigational Site

San Antonio, Texas, United States

GSK Investigational Site

Salt Lake City, Utah, United States

GSK Investigational Site

Salt Lake City, Utah, United States

GSK Investigational Site

Vancouver, Washington, United States

Countries

United States

References

Trofa AF, Levin M, Marchant CD, Hedrick J, Blatter MM. Immunogenicity and safety of an inactivated hepatitis a vaccine administered concomitantly with a pneumococcal conjugate vaccine in healthy children 15 months of age. Pediatr Infect Dis J. 2008 Jul;27(7):658-60. doi: 10.1097/INF.0b013e31816907bd.

Reference Type: BACKGROUND

PMID: 18536623 (View on PubMed)

Study Documents

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

208109/220

Identifier Type: -

Identifier Source: org_study_id