Immunogenicity and Safety of Havrix™ Co-Administered With a Diphtheria, Tetanus and Pertussis and a Haemophilus b Vaccine in Children Aged 15 Months

NCT ID: NCT00197236

Last Updated: 2018-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 468 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-11-11
• Study Completion Date: 2007-12-03

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 diphtheria, tetanus and pertussis combination (DTaP) vaccine and a Haemophilus influenza type B (Hib) vaccine in children 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 Infanrix™ and ActHIB. The three groups evaluated are: 1) Havrix™ alone, 2) Havrix™ + Infanrix™ and ActHIB and 3) Infanrix™ and ActHIB 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

Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.

Group Type: ACTIVE_COMPARATOR

Havrix™

Intervention Type: BIOLOGICAL

2 intramuscular injections, 6 months apart

Infanrix + ActHIB→Havrix Group

Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.

Group Type: EXPERIMENTAL

Havrix™

Intervention Type: BIOLOGICAL

2 intramuscular injections, 6 months apart

Infanrix™

Intervention Type: BIOLOGICAL

1 intramuscular injection

ActHIB™

Intervention Type: BIOLOGICAL

1 intramuscular injection

Havrix + Infanrix + ActHIB Group

Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.

Group Type: ACTIVE_COMPARATOR

Havrix™

Intervention Type: BIOLOGICAL

2 intramuscular injections, 6 months apart

Infanrix™

Intervention Type: BIOLOGICAL

1 intramuscular injection

ActHIB™

Intervention Type: BIOLOGICAL

1 intramuscular injection

Interventions

Havrix™

2 intramuscular injections, 6 months apart

Intervention Type: BIOLOGICAL

Infanrix™

1 intramuscular injection

Intervention Type: BIOLOGICAL

ActHIB™

1 intramuscular injection

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 or 13 months of age at the time of entry into the Enrolment Phase,
• Subjects must have previously received three doses each of DTaP and Hib vaccines during the first year of life. The three doses of DTaP vaccine must have been administered as either Infanrix™ or Pediarix™ and the three doses of Hib vaccine must have been administered as ActHIB™, HibTITER™, OmniHIB™.
• Subjects who, at 15 months of age, will have had at least six months elapse since their third dose of Infanrix™ or Pediarix™,
• 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 31 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.
• Planned administration or administration of any vaccine not foreseen by the study protocol during the period 42 days before and 31 days after each dose of study vaccine(s).
• Previous vaccination against DTaP using a commercially-available brand other than Infanrix™ or Pediarix™ or against Hib using a commercially-available brand other than ActHIB™, HibTITER™ or OmniHIB™.
• Previous vaccination with more than three doses of DTaP-containing vaccines or more than three doses of Hib-containing vaccines.
• Previous vaccination against hepatitis A,
• History or known exposure to hepatitis A,
• History of diphtheria, tetanus, pertussis and/or Haemophilus influenza type b,
• Known exposure to diphtheria, tetanus, pertussis and/or Haemophilus influenza type b within 31 days prior to the start of the study,
• History of non-response to any vaccine in the current routine immunization schedule,
• 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™, Infanrix™ or ActHIB™ including 2-phenoxyethanol, neomycin and gelatin,
• History of hypersensitivity/allergic reaction to latex
• Major congenital defects or serious chronic illness,
• History of any neurologic disorder
• 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, i.e., the Enrolment Phase, the Active Phase and the Extended Safety Follow-up Phase

• 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

Phoenix, Arizona, United States

GSK Investigational Site

Oakland, California, United States

GSK Investigational Site

San Ramon, California, United States

GSK Investigational Site

Wilmington, Delaware, United States

GSK Investigational Site

Pembroke Pines, Florida, United States

GSK Investigational Site

Martinez, Georgia, United States

GSK Investigational Site

Waterloo, Iowa, United States

GSK Investigational Site

Bossier City, Louisiana, United States

GSK Investigational Site

Long Branch, New Jersey, United States

GSK Investigational Site

Ithaca, New York, United States

GSK Investigational Site

Bismarck, North Dakota, United States

GSK Investigational Site

Youngstown, Ohio, United States

GSK Investigational Site

Bellevue, Pennsylvania, United States

GSK Investigational Site

Hershey, Pennsylvania, United States

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

GSK Investigational Site

Charleston, South Carolina, United States

GSK Investigational Site

Beaumont, Texas, United States

GSK Investigational Site

Dallas, Texas, United States

GSK Investigational Site

Danville, Virginia, United States

GSK Investigational Site

Mechanicsville, Virginia, United States

GSK Investigational Site

La Crosse, Wisconsin, United States

Countries

United States

References

Trofa AF, Klein NP, Paul IM, Michaels MG, Goessler M, Chandrasekaran V, Blatter M. Immunogenicity and safety of an inactivated hepatitis A vaccine when coadministered with Diphtheria-tetanus-acellular pertussis and haemophilus influenzae type B vaccines in children 15 months of age. Pediatr Infect Dis J. 2011 Sep;30(9):e164-9. doi: 10.1097/INF.0b013e31821b8a7d.

Reference Type: BACKGROUND

PMID: 21494175 (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: Informed Consent Form

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: Dataset Specification

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

Related Links

https://www.clinicalstudydatarequest.com

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Other Identifiers

208109/232

Identifier Type: -

Identifier Source: org_study_id