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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00678301 |
The purpose of this study is to assess the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of African Sub-Saharan infants with pneumococcal conjugate vaccine GSK 1024850A co-administered with a diphtheria, tetanus, whole cell pertussis (DTPw)-combined vaccine and oral polio vaccine in children during the first 4 months of life.
Condition | Intervention | Phase |
---|---|---|
Pneumococcal Disease |
Biological: GSK Biologicals' Zilbrix™ Hib Biological: Pneumococcal vaccine GSK1024850A Biological: GSK Biologicals' Polio Sabin™ |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Parallel Assignment |
Official Title: | Primary Vaccination Course in Children Receiving the Pneumococcal Vaccine GSK 1024850A co-Administered With Zilbrix™ Hib and Polio Sabin™ |
Estimated Enrollment: | 345 |
Study Start Date: | June 2008 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Group B: No Intervention |
Biological: GSK Biologicals' Zilbrix™ Hib
3 IM doses.
Biological: GSK Biologicals' Polio Sabin™
3 oral doses
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Group A: Experimental |
Biological: GSK Biologicals' Zilbrix™ Hib
3 IM doses.
Biological: Pneumococcal vaccine GSK1024850A
3 IM doses.
Biological: GSK Biologicals' Polio Sabin™
3 oral doses
|
Vaccination course at 6, 10, 14 weeks of age.
Ages Eligible for Study: | 6 Weeks to 10 Weeks |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
Mali | |
GSK Investigational Site | Recruiting |
Bamako, Mali | |
Nigeria | |
GSK Investigational Site | Not yet recruiting |
Ikeja / Lagos, Nigeria, P.M.B. 21266 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 110521 |
Study First Received: | May 13, 2008 |
Last Updated: | October 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00678301 |
Health Authority: | Mali: Ministry of Health |
Streptococcus pneumoniae pneumococcal conjugate vaccine |
Poliomyelitis Pneumonia |