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Home > Protocol Summaries: Compounds > Combined Reduced Antigen Content Diphtheria, Tetanus, Acellular Pertussis Vaccine > Protocol Summary for 263855/035

Protocol Summary for 263855/035

Protocol Summary
Protocol Id: 263855/035
Secondary Ids:
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).
Phase: Phase 4
Acronym:
FDA Regulated Intervention?:
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?: No
Study Type: Interventional
Oversight Authority:
  • Australia: Department of Health and Ageing Therapeutic Goods Administration
Collaborators:
Brief 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.
Detailed Description:
Record Verification Date: September 2009
Status: Terminated
Why Study Stopped:
Study Start Date: May 2003
Study Completion Date:
Study Completion Date Type: None
Primary Completion Date:
Primary Completion Date Type:
Primary Purpose: Prevention
Allocation: Randomized
Masking: Single Blind
Masked Subject: false
Masked Caregiver: false
Masked Investigator: false
Masked Assessor: false
Study Design (Assignment): Parallel Assignment
Study Classification (Endpoint): Safety/Efficacy Study
Primary Outcomes:
  • Anti-diphtheria and anti-tetanus antibody concentration (1M, 15-18M & 27-29M after vacc)
  • Occurrence of local injection site reactions (1M after vacc).
Secondary Outcomes:
  • 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).
Conditions:
  • Diphtheria
  • Tetanus
  • Pertussis
  • Hepatitis A
Keywords:
  • INFANRIX
  • BOOSTRIX
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 18 Months
Maximum Age: 20 Months
Enrollment: 720
Enrollment Type: Actual
Healthy Volunteers?: Yes
Central Contact: US GSK Clinical Trials Call Center
Central Contact Phone: 877-379-3718
Central Contact Email: GSKClinicalSupportHD@gsk.com
Backup Central Contact: EU GSK Clinical Trials Call Center
Backup Central Contact Phone: +44 (0) 20 8990 4466
Backup Central Contact Email: GSKClinicalSupportHD@gsk.com
Overall Study Official: GSK Clinical Trials
Overall Study Official Affiliation: GlaxoSmithKline
Overall Study Official Role: Study Director
Responsible Party Name/Official Title: Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization: GSK Clinical Disclosure
Location and Contact Information: Click to view location information