| 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 |
| |
| |
| |
| 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 |