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Home > Protocol Summaries: Compounds > Combined Diphtheria, Tetanus, Acellular Pertussis, Haemophilus influenzae Type b Conjugate Vaccine > Protocol Summary for 106345

Protocol Summary for 106345

Protocol Summary
Protocol Id: 106345
Secondary Ids:
Title: Open, primary vaccination study to assess safety and reactogenicity of GSK Biologicals’ DTPa/Hib vaccine when administered to healthy chinese infants at 3, 4 and 5 months of age.
Phase: Phase 3
Acronym:
FDA Regulated Intervention?:
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?: No
Study Type: Interventional
Oversight Authority:
  • China: State Food and Drug Administration
Collaborators:
Brief Summary: This study will evaluate the safety and reactogenicity of GSK Biologicals’ Diphtheria Tetanus acellular Pertussis/Haemophilus influenzae type b vaccine given to Chinese infants at 3, 4 and 5 months of age.
Detailed Description:
Record Verification Date: September 2009
Status: Completed
Why Study Stopped:
Study Start Date: September 2006
Study Completion Date:
Study Completion Date Type:
Primary Completion Date:
Primary Completion Date Type:
Primary Purpose: Prevention
Allocation: Non-randomized
Masking: Open Label
Masked Subject:
Masked Caregiver:
Masked Investigator:
Masked Assessor:
Study Design (Assignment): Single Group Assignment
Study Classification (Endpoint): Safety Study
Primary Outcomes:
  • Occurrence of solicited symptoms during the 4 days following vaccination, unsolicited symptoms during the 31 days following vaccination and serious adverse events
Secondary Outcomes:
Conditions:
  • Diphtheria
  • Tetanus
  • Pertussis
  • Hib Disease
Keywords:
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 90 Days
Maximum Age: 120 Days
Enrollment: 30
Enrollment Type:
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