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

Condition(s) targeted: Hepatitis A

Intervention: Hepatitis A (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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

Official title: A Multicenter Study of the Immunogenicity and Safety of GSK Biologicals' Inactivated Hepatitis A Vaccine (Havrix) Administered Concomitantly With Wyeth Lederle's Pneumococcal Conjugate Vaccine (Prevnar) in Healthy Children 15 Mths of Age

Study design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study

Primary outcome: Immune response for Havrix following the second dose of Havrix in both the Havrix group and the Havrix + Prevnar group.

Secondary outcome:

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.

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.

Minimum age: 12 Months. Maximum age: 13 Months. Gender(s): Both.

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.

Starting date: September 2003
Last updated: November 6, 2006