Immunogenicity, Antibody Persistence and Safety of GSK Biologicals' DTPa (INFANRIX) and dTpa (BOOSTRIX) Vaccines.
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diphtheria; Tetanus; Pertussis; Hepatitis A
Intervention: INFANRIX (Biological); BOOSTRIX (Biological); HAVRIX (Biological)
Phase: Phase 3
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
Summary
To evaluate the immunogenicity, persistence of antibodies and reactogenicity of GSK
Biologicals' DTPa (INFANRIX) and dTpa (BOOSTRIX), when administered to subjects 18-20 months
old, compared with not giving a booster DTP vaccine at 18-20 months. Study double blinded
for the two DTP vaccines and single blinded for the control arm.
Clinical Details
Official title: Phase IIIb Study to Evaluate Immunogenicity, Antibody Persistency & Reactogenicity of DTPa - INFANRIX & dTpa - BOOSTRIX Vaccines Admnd to Healthy Children Previously Primed With 3 Doses of DTPa Vaccine Compared to Placebo (HAVRIX®JUNIOR).
Study design: Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Anti-diphtheria and anti-tetanus antibody concentration (1M, 15-18M & 27-29M after vacc)Occurrence of local injection site reactions (1M after vacc).
Secondary outcome: Antibody concentration to all vaccine antigens (1M, 15-18M & 27-29M after vacc),Solicited (Day 0-14) & Unsolicited symptoms (Day 0-30), SAEs (full study).
Eligibility
Minimum age: 18 Months.
Maximum age: 20 Months.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male or female children between and including 18 -20 months of age at the time of the
vaccination.
- Completed a primary vaccination course with DTPa (INFANRIX) vaccine at 2, 4, and 6
months.
- Written informed consent obtained before study entry from the parents or guardians of
the subject.
- Free of obvious health problems as established by medical history and clinical
examination before entering into the study.
Exclusion Criteria:
- Use of any investigational or non-registered drug or vaccine other than the study
vaccine(s) within 30 days preceding the administration of the study vaccine dose, or
planned use during the study period.
- Evidence of previous or intercurrent diphtheria, tetanus, or pertussis disease, or of
vaccination against any of these diseases since completion of the primary course of
DTPa (INFANRIX) vaccine.
Locations and Contacts
GSK Clinical Trials Call Center, Victoria, Australia
Additional Information
Starting date: May 2003
Last updated: October 15, 2007
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