Infections, Streptococcal Clinical Trial
Official title:
To Assess the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Pneumococcal Conjugate Vaccine Compared to Prevenar™, Co-administered With DTPw-HBV/Hib & OPV or IPV Vaccines as a 3-dose Primary Immunization Course During the First 6 Months of Age
This study will evaluate safety, reactogenicity and immunogenicity of GSK Biologicals'
pneumococcal conjugate vaccine compared to Prevenar™ when co-administered with DTPw-HBV/Hib
and OPV or IPV vaccines, according to 2 different schedules: 6-10-14 weeks or 2-4-6 months of
age.
The study has 2 groups.
- One group of subjects will receive a 3-dose primary vaccination with the GSK
Biologicals' pneumococcal conjugate vaccine (three different lots will be used and
randomly allocated).
- The 2nd group of subjects will receive a 3-dose primary vaccination with Prevenar™.
All children will receive concomitantly DTPw-HBV/Hib and OPV or IPV vaccines. This protocol
posting deals with objectives & outcome measures of the primary study. The objectives &
outcome measures of the Booster study are presented in a separate protocol posting (NCT
number =00547248).
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007 ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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Primary Vaccination With Either Synflorix™ or Prevenar 13™ or Both Vaccines and Booster Vaccination With Synflorix™
|
Phase 3 | |
| Completed |
NCT01204658 -
Safety & Immunogenicity of Pneumococcal Vaccine 2189242A Co-administered With DTPa-HBV-IPV/Hib in Healthy Infants
|
Phase 2 | |
| Completed |
NCT00370396 -
Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine.
|
Phase 3 | |
| Completed |
NCT02838407 -
Identification and Characterization of Bacteria in the Lungs of Children From 6 Months up to 6 Years Old, With Suspected Infection of the Lungs, in Spain.
|
N/A | |
| Completed |
NCT00523770 -
Exploratory Study in Healthy Elderly Subjects to Collect Urine for Development of Assays to Detect S. Pneumoniae
|
N/A | |
| Completed |
NCT00756067 -
Evaluation of Pneumococcal Vaccine Formulations in Elderly
|
Phase 1 | |
| Completed |
NCT00345358 -
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine
|
Phase 3 | |
| Completed |
NCT01153893 -
Immunization of Children Previously Primed With GSK Pneumococcal Vaccine GSK1024850A and of Unprimed Children in Nigeria
|
Phase 3 | |
| Completed |
NCT00307541 -
Assess the Immunogenicity of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine
|
Phase 3 | |
| Completed |
NCT00547248 -
Pneumococcal Vaccine Booster Study in Healthy Children 12-18 Mths Old Previously Primed With the Same Vaccines
|
Phase 3 | |
| Withdrawn |
NCT01160055 -
Study to Characterize and Identify Bacteria Causing Acute Otitis Media in Young Egyptian Children
|
N/A | |
| Completed |
NCT00370227 -
Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine
|
Phase 3 | |
| Completed |
NCT00390910 -
Study to Evaluate the Safety and Immunogenicity of a 10-valent Pneumococcal Conjugate Vaccine in Preterm Infants
|
Phase 3 | |
| Completed |
NCT00985751 -
Safety & Immunogenicity of Pneumococcal Vaccine 2189242A in Children Aged 12-23 Months at the Time of First Vaccination
|
Phase 2 | |
| Withdrawn |
NCT01031329 -
Study to Identify and Characterize Bacteria Causing Acute Otitis Media in Young Children in Turkey
|
N/A | |
| Completed |
NCT00307554 -
A Lot-to-lot Consistency (3 Lots of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine) & Non-inferiority Study
|
Phase 3 | |
| Completed |
NCT02270944 -
Safety and Immunogenicity of the Liquid Formulation of Group B Streptococcus Trivalent Vaccine and of the Lyophilized Formulation of Group B Streptococcus Trivalent Vaccine
|
Phase 2 | |
| Completed |
NCT01235949 -
Primary and Booster Vaccination Study With Pneumococcal Vaccine GSK1024850A and Prophylactic Antipyretic Treatment
|
Phase 4 | |
| Completed |
NCT00985465 -
Immunization of Children Previously Primed With GSK Pneumococcal Vaccine GSK1024850A and of Unprimed Children in Mali
|
Phase 3 | |
| Completed |
NCT00861380 -
Evaluation of Effectiveness of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A Against Invasive Disease
|
Phase 3 |