Trials / Completed
CompletedNCT00970307
Immunogenicity and Safety Study of GSK Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 3 and 4 Months of Age
Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 3 and 4 Months of Age
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 421 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 8 Weeks – 12 Weeks
- Healthy volunteers
- Accepted
Summary
This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine co-administered with GSK Biologicals' 10-valent pneumococcal conjugate (GSK1024850A) vaccine given as a three-dose primary vaccination course at 2, 3 and 4 months of age.
Detailed description
In accordance with the local recommended immunisation schedule, all subjects will receive 2 doses of GSK Biologicals' Human Rotavirus Vaccine (Rotarix) at 2 and 3 months of age.
Conditions
- Tetanus
- Diphtheria
- Haemophilus Influenzae Type b
- Poliomyelitis
- Acellular Pertussis
- Hepatitis B
- Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b-Neisseria Meni
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | GSK2202083A vaccine | Intramuscular, three doses |
| BIOLOGICAL | 10-valent pneumococcal vaccine (GSK 1024850A) | Intramuscular, three doses |
| BIOLOGICAL | Infanrix hexa™ | Intramuscular, three doses |
| BIOLOGICAL | Menjugate® | Intramuscular, two doses |
Timeline
- Start date
- 2009-08-13
- Primary completion
- 2010-01-27
- Completion
- 2010-01-27
- First posted
- 2009-09-02
- Last updated
- 2020-01-03
- Results posted
- 2017-04-14
Locations
9 sites across 1 country: Poland
Source: ClinicalTrials.gov record NCT00970307. Inclusion in this directory is not an endorsement.