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Immune Response & Safety Comparison of 3 Lots of GSK Biologicals' DTaP-IPV Candidate Vaccine to DTaP + IPV Vaccine

This study has been completed.
Study NCT00148941.   Last updated on October 9, 2008.   Information provided by GlaxoSmithKline

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Descriptive Information Fields
Brief Title  Immune Response & Safety Comparison of 3 Lots of GSK Biologicals' DTaP-IPV Candidate Vaccine to DTaP + IPV Vaccine
Official Title  Safety, Immunogenicity&Consistency of 3 Manufacturing Lots of DTaP-IPV Vaccine vs Separate Injections of GSK Biologicals' DTaP + Aventis Pasteur's IPV Admd as Booster Doses to Healthy Children 4-6 Yrs, Each co-Admd With Merck's MMR Vaccine
Brief Summary

"The aims of this trial are to demonstrate the consistency of three manufacturing lots of GSK Biologicals' DTaP-IPV candidate vaccine in terms of immunogenicity and to evaluate non-inferiority of GSK Biologicals' DTaP-IPV vaccine with respect to immunogenicity and safety compared to the control vaccines (separate injections of GSK Biologicals' DTaP vaccine [Infanrix] and Aventis Pasteur's IPV vaccine [IPOL]) when administered as a 5th dose of DTaP and a 4th dose of inactivated poliovirus vaccine in subjects 4 to 6 years of age. Vaccines will be co-administered with the second dose of M-M-RII, which is recommended at this age. Concomitant administration of a US-licensed influenza vaccine will be allowed according to seasonal availability of vaccine and at the discretion of the investigator."

Detailed Description
  • Investigational groups: 3, each receive one of 3 lots of DTaP-IPV vaccine.
  • Control: US-licensed DTaP (Infanrix) + US-licensed IPV (IPOL) vaccines administered in separate injections.
  • Two study visits one month apart for a subset of subjects (Safety and Immunogenicity subset) with a blood draw at each visit. All other subjects will have one visit.
  • A telephone contact 4-6 days after vaccination for all subjects, a telephone contact 31-38 days after vaccination for the Safety only subset and a telephone contact for all subjects during the extended safety follow-up phase (5 months following the active phase).
Study Phase Phase III
Study Type  Interventional
Study Design  Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure  Lot-to-lot consistency: immunogenicity one month post-vaccination:
Anti-D antibody concentrations, anti-T antibody concentrations, anti-PT antibody concentrations, anti-FHA antibody concentrations, anti-PRN antibody concentrations, anti-poliovirus type 1, type 2 and type 3 antibody titers.
Non-inferiority: immunogenicity one month post-vaccination:
Anti-D booster response, anti-T booster response, anti-PT booster response, anti-FHA booster response, anti-PRN booster response, anti-poliovirus type 1, type 2 and type 3 antibody titers
Safety:
incidence of increased circumferential swelling at the DTaP-containing vaccine injection site within 4 days after vaccination.
Secondary Outcome Measure  Immunogenicity one month after vaccination:
Anti-D antibody concentration, anti-T antibody concentration, anti-PT antibody concentration, anti-FHA antibody concentration, anti-PRN antibody concentration, anti-poliovirus type 1, type 2 and type 3 booster response
Safety:
Safety and reactogenicity of the study vaccines in all groups during the entire study period
Condition  Prophylaxis
Diphtheria
Tetanus
Pertussis
Poliomyelitis
Intervention  Biological: Diphtheria, tetanus, pertussis, poliovirus type 1, 2 & 3
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  4200
Start Date  January 2005
Completion Date
Eligibility Criteria 

Inclusion criteria:

  • Healthy male or female child between and including 4 and 6 years of age at the time of vaccination.
  • Subjects should have received 4 doses of GSK DTaP (primary vaccination course with booster dose in the second year of life) and 3 doses of IPV during the first 2 years of life and vaccination against measles, mumps, and rubella in the second year of life.

Exclusion criteria:

  • Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the administration of study vaccines, or planned use during the study period.
  • Administration or planned administration of a vaccine not foreseen by the study protocol within 30 days of study vaccination and ending at Day 30.
  • Chronic administration or planned administration of immunosuppressants or other immune modifying drugs within six months prior to study vaccination or planned administration during the study period.
  • Administration of immunoglobulins and/or blood products within 3 months prior to vaccination or planned administration during the study period.
Gender Both
Ages 4 Years to 6 Years
Accepts Healthy Volunteers Yes
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00148941
Organization ID 213503/048
Secondary IDs ††
Study Sponsor  GlaxoSmithKline
Collaborators ††
Investigators 
Study Director:     GSK Clinical Trials     GlaxoSmithKline    
Information Provided By GlaxoSmithKline
Verification Date October 2008
First Received Date  September 7, 2005
Last Updated Date October 9, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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