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

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: September 13, 2005
Last updated: August 8, 2013
Last verified: August 2013
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.

Condition Intervention Phase
Hepatitis A
Biological: Hepatitis A
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase IIIb, Open, Randomized, Controlled, Multicenter Study of the Immunogenicity and Safety of GSK Biologicals' Inactivated Hepatitis A Vaccine Administered on a 0-6 Mth Schedule Concomitantly With Wyeth Lederle's Pneumococcal Conjugate Vaccine in Healthy Children 15 Months of Age

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Immune response for Havrix following the second dose of Havrix in both the Havrix group and the Havrix + Prevnar group. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immune response for Prevnar following vaccination in both the Havrix + Prevnar group and the Prevnar followed by Havrix group. [ Designated as safety issue: No ]
  • Immune response for Havrix following the first dose of Havrix in all groups. The other secondary outcome measure is safety of the study vaccines. [ Designated as safety issue: No ]

Enrollment: 521
Study Start Date: September 2003
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: Hepatitis A
    Two doses
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.

Ages Eligible for Study:   12 Months to 13 Months   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00197002

Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline Identifier: NCT00197002     History of Changes
Other Study ID Numbers: 208109/220 
Study First Received: September 13, 2005
Last Updated: August 8, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis A
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Immunologic Factors
Physiological Effects of Drugs processed this record on August 25, 2016