Trials / Completed
CompletedNCT01171989
Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine Administered as a Booster Dose
Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine Administered as a Booster Dose in 12-18 Months Old Healthy Children
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 391 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 12 Months – 18 Months
- Healthy volunteers
- Accepted
Summary
The current trial will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine when administered as a booster dose following priming in the first year of life with the same vaccine. This protocol posting deals with objectives \& outcome measures of the booster phase. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00970307).
Conditions
- Tetanus
- Diphtheria
- Haemophilus Influenzae Type b
- Hepatitis B
- Poliomyelitis
- Acellular Pertussis
- Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b-Neisseria Meni
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | GSK2202083A vaccine | Intramuscular, one dose. |
| BIOLOGICAL | Infanrix hexa™ | Intramuscular, one dose. |
| BIOLOGICAL | Menjugate™ | Intramuscular, one dose. |
| BIOLOGICAL | NeisVac-C™ | Intramuscular, one dose. |
| BIOLOGICAL | Synflorix™ | Intramuscular, one dose. |
Timeline
- Start date
- 2010-08-18
- Primary completion
- 2010-12-03
- Completion
- 2010-12-03
- First posted
- 2010-07-29
- Last updated
- 2020-01-21
- Results posted
- 2017-04-11
Locations
9 sites across 1 country: Poland
Source: ClinicalTrials.gov record NCT01171989. Inclusion in this directory is not an endorsement.