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| Sponsored by: |
GlaxoSmithKline |
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00533507 |
Purpose
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 Taiwanese infants with pneumococcal conjugate vaccine GSK 1024850A co-administered with a diphtheria, tetanus, acellular pertussis (DTPa)-combined vaccine and rotavirus vaccine in children during the first 6 months of life.
| Condition | Intervention | Phase |
|
Pneumococcal Diseases |
Biological: Pneumococcal conjugate vaccine GSK1024850A. Biological: Infanrix hexa. Biological: Rotarix. |
Phase III |
| MedlinePlus related topics: | Diphtheria Tetanus |
| ChemIDplus related topics: | Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines RotaTeq Infanrix hexa |
| Study Type: | Interventional |
| Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Primary Vaccination Course in Children Receiving the Pneumococcal Vaccine GSK 1024850A, Infanrix Hexa and Rotarix |
| Estimated Enrollment: | 230 |
| Study Start Date: | September 2007 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
10Pn group: Experimental
Subjects receiving pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) at 1.5-3-6 months of age, and co-administered with HRV (Rotarix) at 1.5-3 months of age.
|
Biological: Pneumococcal conjugate vaccine GSK1024850A.
Intramuscular injection, 3 doses.
Biological: Infanrix hexa.
Intramuscular injection, 3 doses.
Biological: Rotarix.
Oral, 2 doses.
|
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Eligibility
| Ages Eligible for Study: | 6 Weeks to 8 Weeks |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | GSK Biologicals ( Isabelle Harpigny ) |
| Study ID Numbers: | 109861 |
| First Received: | September 20, 2007 |
| Last Updated: | July 10, 2008 |
| ClinicalTrials.gov Identifier: | NCT00533507 |
| Health Authority: | Taiwan: Department of Health |
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