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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00489554 |
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 Mexican infants with pneumococcal conjugate vaccine GSK 1024850A co-administered with a diphtheria, tetanus, acellular pertussis (DTPa)-combined vaccine (Infanrix Hexa) and rotavirus vaccine (Rotarix) in children during the first 6 months of age.
| Condition | Intervention | Phase |
|---|---|---|
|
Pneumococcal Disease |
Biological: Pneumococcal conjugate vaccine GSK1024850A. Biological: Infanrix hexa. Biological: Rotarix. |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Primary Vaccination Course in Children Receiving the Pneumococcal Vaccine GSK 1024850A, Infanrix Hexa and Rotarix |
| Enrollment: | 230 |
| Study Start Date: | July 2007 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 10Pn group
Subjects receiving pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) at 2-4-6 months of age, and co-administered with HRV (Rotarix) at 2-4 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 12 Weeks |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Mexico | |
| GSK Investigational Site | |
| Mexico, Mexico, 14080 | |
| GSK Investigational Site | |
| Mexico city, Mexico, 14000 | |
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT00489554 History of Changes |
| Other Study ID Numbers: | 109661 |
| Study First Received: | June 20, 2007 |
| Last Updated: | December 1, 2011 |
| Health Authority: | Mexico: Comisión de autorización Sanitaria - Dirección Ejecutiva de Autorización de Productos y Establecimientos |
|
Primary vaccination Safety Pneumococcal vaccine. Pneumococcal disease Immunogenicity |