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Comparison of GSK Biologicals' DTaP-IPV Candidate Vaccine to DTaP and IPV Separately Administered Vaccines in Terms of Immune Response and Safety.
This study has been completed.
Study NCT00263692   Information provided by GlaxoSmithKline
First Received: December 8, 2005   Last Updated: October 9, 2008   History of Changes

December 8, 2005
October 9, 2008
November 2002
 
Immunogenicity after vaccination.
Same as current
Complete list of historical versions of study NCT00263692 on ClinicalTrials.gov Archive Site
Immunogenicity and safety after vaccination.
Same as current
 
Comparison of GSK Biologicals' DTaP-IPV Candidate Vaccine to DTaP and IPV Separately Administered Vaccines in Terms of Immune Response and Safety.
See Detailed Description

The aims of this study are to compare the immunogenicity and safety of the GSK Biologicals' combined DTaP-IPV vaccine with separate administration of DTaP and IPV vaccines, when administered as a fifth dose of acellular pertussis vaccine to children aged 4 to 6 years when co-administered with MMR vaccine in subjects who had previously received four doses of Infanrix, three doses of poliovirus-containing vaccine and MMR vaccination.

Open, randomized, phase II, clinical trial to compare the immunogenicity and safety of a booster dose of GSK Biologicals' DTaP-IPV vaccine (Infanrix®-IPV) co-administered with a booster dose of Merck and Company's M-M-R®II, to that of separate injections of GSK Biologicals' DTaP vaccine (Infanrix®), Aventis Pasteur's IPV (IPOL®) and M-M-R®II administered as booster doses to healthy children 4 to 6 years of age.

Phase II
Interventional
Prevention, Randomized, Open Label, Crossover Assignment, Safety/Efficacy Study
Prophylaxis: Diphtheria, Tetanus, Pertussis, Poliovirus
Biological: Prophylaxis: Diphtheria, tetanus, pertussis, poliovirus type 1, type 2 and type 3
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
400
 
 

"Inclusion criteria Healthy children between and including 4 and 6 years of age. Previously received 4 doses of GSK Biologicals' DTaP, 3 doses of IPV vaccine and 1 dose of measles, mumps, and rubella vaccine.

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.

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."

Both
4 Years to 6 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00263692
Study Director, GSK
213503/047
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