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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   Information provided by GlaxoSmithKline
First Received: September 7, 2005   Last Updated: October 9, 2008   History of Changes

September 7, 2005
October 9, 2008
January 2005
 
  • 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.
  • "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.
  • "
Complete list of historical versions of study NCT00148941 on ClinicalTrials.gov Archive Site
  • 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
  • "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"
 
Immune Response & Safety Comparison of 3 Lots of GSK Biologicals' DTaP-IPV Candidate Vaccine to DTaP + IPV Vaccine
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

"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."

  • 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).
Phase III
Interventional
Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
  • Prophylaxis
  • Diphtheria
  • Tetanus
  • Pertussis
  • Poliomyelitis
Biological: Diphtheria, tetanus, pertussis, poliovirus type 1, 2 & 3
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
4200
 
 

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.
Both
4 Years to 6 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00148941
Study Director, GSK
213503/048
GlaxoSmithKline
 
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP