Immune Response & Safety of a Hepatitis A Vaccine Given Together With a Diphtheria, Tetanus & Pertussis Vaccine (DTaP) Vaccine & a Haemophilus Influenza Type B (Hib) Vaccine in Healthy Children 15 m of Age
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
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
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 as
young as 15 months of age
Clinical Details
Official title: Study of the Immunogenicity & Safety of GSK Biologicals' Inactivated Hepatitis A Vaccine (Havrix) Administered Concomitantly With GSK Biologicals' DTaP Vaccine (Infanrix) & Aventis Pasteur's Haemophilus b Conjugate Vaccine (ActHIB) in Healthy Children 15 m 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 + Infanrix and ActHIB group.Immune response for DTaP and Hib following vaccination with Infanrix and ActHIB in both the Havrix + Infanrix and ActHIB group and the Infanrix and ActHIB followed by Havrix group.
Secondary outcome: 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 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.
Eligibility
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
- 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.
Exclusion criteria:
- Use of any investigational or non-registered drug or vaccine within 31 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.
- 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 of or known exposure to hepatitis A
- History of or known exposure to diphtheria, tetanus, pertussis and/or Haemophilus
influenza type b within 31 days prior to the start of the study
- 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 (a 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
Locations and Contacts
Oakland, California 94612, United States
San Ramon, California 94583, United States
Pembroke Pines, Florida 33024, United States
Bossier City, Louisiana 7111, United States
Bismark, North Dakota 58501, United States
Pittsburgh, Pennsylvania 15241, United States
Pittsburgh, Pennsylvania 15202, United States
Hershey, Pennsylvania 17033, United States
Pittsburgh, Pennsylvania 15213, United States
Charleston, South Carolina 29425, United States
Dallas, Texas 75235, United States
Beaumont, Texas 77701, United States
Mechanicsville, Virginia 23111, United States
LaCrosse, Wisconsin 54601, United States
Additional Information
Starting date: November 2003
Ending date: December 2007
Last updated: January 25, 2008
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