Immunogenicity & Safety of Hepatitis A Vaccine Co-admin With a Measles/Mumps/Rubella & a Varicella Vaccine in Children

NCT ID: NCT00197015

Last Updated: 2018-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1474 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-06
• Study Completion Date: 2009-06-09

Brief Summary

This is a study to evaluate the immune response and safety of GSK Biologicals 2-dose inactivated hepatitis A vaccine when administered with a measles/mumps/rubella vaccine and a varicella (chickenpox) vaccine in children as young as 15 months of age.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed Description

An open, controlled comparison of Havrix™ administered alone or with MMR II and Varivax™. The three groups evaluated are: 1) Havrix™ alone, 2) Havrix™ + MMR II and Varivax™ and 3) MMR II and Varivax™ 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

HAV Group

Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)

Group Type: ACTIVE_COMPARATOR

Havrix®

Intervention Type: BIOLOGICAL

2 doses administered intramuscularly

HAV+MMR+V Group

Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9

Group Type: EXPERIMENTAL

Havrix®

Intervention Type: BIOLOGICAL

2 doses administered intramuscularly

M-M-R®II

Intervention Type: BIOLOGICAL

1 dose administered subcutaneously

VARIVAX®

Intervention Type: BIOLOGICAL

1 dose administered subcutaneously

MMR+V→HAV Group

Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)

Group Type: ACTIVE_COMPARATOR

Havrix®

Intervention Type: BIOLOGICAL

2 doses administered intramuscularly

M-M-R®II

Intervention Type: BIOLOGICAL

1 dose administered subcutaneously

VARIVAX®

Intervention Type: BIOLOGICAL

1 dose administered subcutaneously

Interventions

Havrix®

2 doses administered intramuscularly

Intervention Type: BIOLOGICAL

M-M-R®II

1 dose administered subcutaneously

Intervention Type: BIOLOGICAL

VARIVAX®

1 dose administered subcutaneously

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Subjects whose parents/guardians are believed by the investigator to be willing to comply with the requirements of the protocol
• A male or female child 12 and 13 months of age at the time of entry into the Enrollment Phase
• Written informed consent obtained from the parents or guardian of the subject,
• Free of obvious health problems as established by medical history and history-directed physical examination before entering into the study, and
• Parents/guardian of the subject must have a telephone or be able to be contacted by telephone

Exclusion Criteria

• Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 42 days preceding the first dose of study vaccine, or planned use during the study period, Chronic administration (defined as more than 14 days) 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, ≥0.5 mg/kg/day. Inhaled, nasal and topical steroids are allowed.) Planned administration or administration of any vaccine not foreseen by the study protocol during the period 31 days before and 31 days after each dose of study vaccine(s).
• Previous vaccination against hepatitis A,
• History of hepatitis A,
• Known exposure to hepatitis A,
• Previous vaccination against measles, mumps, rubella and/or varicella,
• History of measles, mumps, rubella and/or varicella,
• Known exposure to measles, mumps, rubella and/or varicella within 30 days prior to the start of the study,
• Planned chronic use of salicylates during the 6-week period following administration of the doses of study vaccine(s),
• 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 HavrixTM, M-M-RII or VARIVAXTM, including 2-phenoxyethanol, neomycin and gelatin,
• History of anaphylactic or anaphylactoid reactions to egg proteins,
• History of hypersensitivity/allergic reaction to latex. Note: The tip cap and the rubber plunger of the HavrixTM needleless pre-filled syringes contain dry natural latex rubber.
• Major congenital defects or serious chronic illness,
• Active untreated tuberculosis,
• History of significant blood dyscrasias
• History of any neurologic disorder (a history of febrile seizures not associated with an underlying neurological disorder does not exclude the subject)
• Acute disease 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

Cabot, Arkansas, United States

GSK Investigational Site

Jonesboro, Arkansas, United States

GSK Investigational Site

North Little Rock, Arkansas, United States

GSK Investigational Site

Huntington Beach, California, United States

GSK Investigational Site

Oakland, California, United States

GSK Investigational Site

Rolling Hills Estates, California, United States

GSK Investigational Site

Norwich, Connecticut, United States

GSK Investigational Site

Jacksonville, Florida, United States

GSK Investigational Site

Marietta, Georgia, United States

GSK Investigational Site

Waterloo, Iowa, United States

GSK Investigational Site

Waukee, Iowa, United States

GSK Investigational Site

Lexington, Kentucky, United States

GSK Investigational Site

Bossier City, Louisiana, United States

GSK Investigational Site

Baltimore, Maryland, United States

GSK Investigational Site

Henderson, Nevada, United States

GSK Investigational Site

Las Vegas, Nevada, United States

GSK Investigational Site

Albany, New York, United States

GSK Investigational Site

Brooklyn, New York, United States

GSK Investigational Site

Rochester, New York, United States

GSK Investigational Site

Syracuse, New York, United States

GSK Investigational Site

Lumberton, North Carolina, United States

GSK Investigational Site

Sylva, North Carolina, United States

GSK Investigational Site

Cleveland, Ohio, United States

GSK Investigational Site

University Heights, Ohio, United States

GSK Investigational Site

Tulsa, Oklahoma, United States

GSK Investigational Site

Beaver Falls, Pennsylvania, United States

GSK Investigational Site

Norristown, Pennsylvania, United States

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

GSK Investigational Site

Rydal, Pennsylvania, United States

GSK Investigational Site

Sellersville, Pennsylvania, United States

GSK Investigational Site

Warwick, Rhode Island, United States

GSK Investigational Site

Bristol, Tennessee, United States

GSK Investigational Site

Kingsport, Tennessee, United States

GSK Investigational Site

Kingsport, Tennessee, United States

GSK Investigational Site

Austin, Texas, United States

GSK Investigational Site

San Antonio, Texas, United States

GSK Investigational Site

Temple, Texas, United States

GSK Investigational Site

Layton, Utah, United States

GSK Investigational Site

South Jordan, Utah, United States

GSK Investigational Site

Norfolk, Virginia, United States

GSK Investigational Site

Marshfield, Wisconsin, United States

Countries

United States

References

Rinderknecht S, Michaels MG, Blatter M, Gaglani M, Andrews W, Abughali N, Chandreshekaran V, Trofa AF. Immunogenicity and safety of an inactivated hepatitis A vaccine when coadministered with measles-mumps-rubella and varicella vaccines in children less than 2 years of age. Pediatr Infect Dis J. 2011 Oct;30(10):e179-85. doi: 10.1097/INF.0b013e31822256a5.

Reference Type: BACKGROUND

PMID: 21617573 (View on PubMed)

Study Documents

Document Type: Clinical Study Report

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: Dataset Specification

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

Document Type: Study Protocol

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

Related Links

https://www.clinicalstudydatarequest.com

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Other Identifiers

208109/231

Identifier Type: -

Identifier Source: org_study_id