Immunogenicity and Reactogenicity of GSK Bio DTPa-HBV-IPV and Hib Vaccines When Coadministered to Healthy Infants
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diphtheria; Tetanus; Whooping Cough; Hepatitis B; Poliovirus; Haemophilus Influenzae Type b Disease
Intervention: Hiberix TM (Biological); Pediarix TM, Infanrix penta TM (Biological)
Phase: Phase 3
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
Summary
The purpose of this study is to evaluate the immune response and reactogenicity of GSK
Biologicals' DTPa-HBV-IPV combined pentavalent vaccine and Hib tetanus conjugate vaccine,
administered concomitantly as a three-dose primary vaccination course.
Clinical Details
Official title: Immunogenicity and Reactogenicity of GSK Biologicals' DTPa-HBV-IPV and Hib Vaccines When Administered Concomitantly to Healthy Infants Administered as a Three-Dose Primary Vaccination Course at the Age of 1.5, 3.5 and 6 Months
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Anti-PT, anti-FHA and anti-PRN antibody titers.Anti-diphtheria toxoid and anti-tetanus toxoid antibody titers Anti-HBs antibody titers Anti-polio virus types 1, 2 and 3 antibody titers Anti-PRP antibody titers
Secondary outcome: Occurrence of solicited adverse eventsOccurrence of unsolicited adverse events Occurrence of Serious Adverse Events
Eligibility
Minimum age: 6 Weeks.
Maximum age: 8 Weeks.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- A male or female infant between 6 and 8 weeks of age at the time of the first
vaccination.
- Free of obvious health problems as established by medical history and clinical
examination before entering into the study.
- Written informed consent obtained from the parents or guardians of the subject.
- Born after a normal gestation period (between 36 and 42 weeks).
Exclusion Criteria:
- Use of any investigational or non-registered drug or vaccine other than the study
vaccine(s) during the study period or within 30 days preceding the first dose of
study vaccine.
- Administration of chronic immunosuppressants or other immune-modifying drugs since
birth or planned administration during the study.
- Planned administration/ administration of a vaccine not foreseen by the study
protocol during the period starting from 30 days before each dose of vaccine(s) and
ending 30 days after.
- Previous vaccination against diphtheria, tetanus, pertussis, polio or Haemophilus
influenzae type b.
- History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B, polio
and/or Haemophilus influenzae type b.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including
human immunodeficiency virus infection.
- Major congenital defects
- Serious chronic illness
- History of allergic disease or reactions likely to be exacerbated by any component of
the vaccines.
- Administration of immunoglobulins and/or any blood products since birth or planned
administration during the study period.
- Acute disease at the time of enrollment.
Locations and Contacts
Additional Information
Starting date: September 2000
Last updated: April 9, 2009
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