Clinical trial
Assessment of GSK Biologicals' Tdap Candidate Vaccine Administered as a Booster…
NCT00263679 · GlaxoSmithKline, Industry · Completed
Key facts
| NCT number | NCT00263679 |
|---|---|
| Title | Assessment of GSK Biologicals' Tdap Candidate Vaccine Administered as a Booster (6th Dose) in Terms of Immunogenicity and Safety to Children and Adolescents Previously Vaccinated With Five Doses of an Acellular Pertussis-containing Vaccine. |
| Official title | A Phase III, Double-blinded, Randomized, Multicenter, Clinical Study to Assess the Safety and Immunogenicity of GSK Biologicals' Tdap 0.3 mg Candidate Vaccine When Given as a Booster Dose to Healthy School Children and Adolescents (9-13 Years of Age), Previously Vaccinated With a 5th Consecutive… |
| Lead sponsor | GlaxoSmithKline, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Acellular Pertussis, Diphtheria, Tetanus |
| Intervention type | Biological |
| Interventions | Prophylaxis: Diphtheria, tetanus and pertussis |
| Enrollment | 321 |
| Start date | Nov 1, 2003 |
| Primary completion | May 1, 2004 |
| Completion | Oct 1, 2004 |
| First posted | Dec 9, 2005 |
| Last update posted | Sep 15, 2016 |
| Countries | Germany |
At a glance
- 10–99 Study sites
- No Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: