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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00808444 |
The purpose of the present study is to demonstrate that the changes in the manufacturing process for the commercial lot of the pneumococcal conjugate vaccine GSK1024850A have no clinical impact and that the immune responses are non-inferior to the immune responses induced by the clinical lot. The study will be conducted in Singapore and Malaysia.
Condition | Intervention | Phase |
---|---|---|
Pneumococcal Disease |
Biological: Pneumococcal conjugate vaccine GSK1024850A (different lots) Biological: Infanrix-IPV/Hib Biological: Infanrix hexa Biological: Rotarix |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Caregiver, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | Non-Inferiority of a Commercial Lot of the Pneumococcal Vaccine GSK1024850A Compared to a Clinical Lot. |
Estimated Enrollment: | 460 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group B: Experimental
Subjects receiving the commercial lot of pneumococcal conjugate vaccine GSK1024850A co-administered with a DTPa-combined vaccine (Infanrix hexa or Infanrix-IPV/Hib) at 2-3-5 months of age and Rotarix at 2-3 months of age.
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Biological: Pneumococcal conjugate vaccine GSK1024850A (different lots)
Intramuscular injection, 3 doses
Biological: Infanrix-IPV/Hib
Intramuscular injection, only for Visit 2 in Singapore
Biological: Infanrix hexa
Intramuscular injection, 3 doses in Malaysia and 2 doses in Singapore
Biological: Rotarix
Oral, 2 doses
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Group A: Experimental
Subjects receiving the clinical lot of pneumococcal conjugate vaccine GSK1024850A co-administered with a DTPa-combined vaccine (Infanrix hexa or Infanrix-IPV/Hib) at 2-3-5 months of age and Rotarix at 2-3 months of age.
|
Biological: Pneumococcal conjugate vaccine GSK1024850A (different lots)
Intramuscular injection, 3 doses
Biological: Infanrix-IPV/Hib
Intramuscular injection, only for Visit 2 in Singapore
Biological: Infanrix hexa
Intramuscular injection, 3 doses in Malaysia and 2 doses in Singapore
Biological: Rotarix
Oral, 2 doses
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Ages Eligible for Study: | 6 Weeks to 12 Weeks |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
Malaysia | |
GSK Investigational Site | Active, not recruiting |
Seremban, Negeri Sembilan, Malaysia, 70300 | |
GSK Investigational Site | Recruiting |
Kuala Lumpur, Malaysia, 59100 | |
Singapore | |
GSK Investigational Site | Not yet recruiting |
Singapore, Singapore, 119074 | |
GSK Investigational Site | Not yet recruiting |
Singapore, Singapore, 229899 | |
GSK Investigational Site | Not yet recruiting |
Singapore, Singapore, 308433 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 111654 |
Study First Received: | December 11, 2008 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00808444 |
Health Authority: | Malaysia: Ministry of Health |
Pneumococcal vaccine Pneumococcal disease Immunogenicity Safety Primary vaccination |
Healthy |