Trials / Completed
CompletedNCT00871000
Immunogenicity and Safety of Boostrix Polio Vaccine as a Booster Dose in 5 to 6-year-old Children.
Immunogenicity and Safety of GSK Biologicals' dTpa-IPV Vaccine (Boostrix Polio) as a Booster Dose in 5 to 6-year-old Children.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 303 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 5 Years – 6 Years
- Healthy volunteers
- Accepted
Summary
This phase 3b study will compare the immunogenicity and reactogenicity of the dTpa-IPV vaccine to that of a DTPa-IPV vaccine when administered as a booster dose in healthy children 5-6 years of age who have received three primary vaccination doses of DTPa-based vaccine according to the "3-5-11" month schedule recommended in Italy. In this study, MMRV vaccine will also be co-administered to all children.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Boostrix Polio™ 711866 | Single dose, intramuscular administration. |
| BIOLOGICAL | Priorix Tetra TM 208136 | Single dose, subcutaneously. |
| BIOLOGICAL | Tetravac TM | Single dose, intramuscular administration. |
Timeline
- Start date
- 2009-04-01
- Primary completion
- 2009-11-18
- Completion
- 2009-11-18
- First posted
- 2009-03-30
- Last updated
- 2018-06-06
- Results posted
- 2017-04-18
Locations
8 sites across 1 country: Italy
Source: ClinicalTrials.gov record NCT00871000. Inclusion in this directory is not an endorsement.