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.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00197002
First received: September 13, 2005
Last updated: August 8, 2013
Last verified: August 2013

September 13, 2005
August 8, 2013
September 2003
May 2006   (final data collection date for primary outcome measure)
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 ]
Immune response for Havrix following the second dose of Havrix in both the Havrix group and the Havrix + Prevnar group.
Complete list of historical versions of study NCT00197002 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Immune response for Prevnar following vaccination in both the Havrix + Prevnar group and the Prevnar followed by Havrix group.
  • Immune response for Havrix following the first dose of Havrix in all groups. The other secondary outcome measure is safety of the study vaccines.
Not Provided
Not Provided
 
Immune Response & Safety of a Hepatitis A Vaccine Given Together With a Pneumococcal Vaccine in Healthy Children 15 m of Age
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Hepatitis A
Biological: Hepatitis A
Two doses
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
521
May 2006
May 2006   (final data collection date for primary outcome measure)

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.
Both
12 Months to 13 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00197002
208109/220
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP