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Tetraxim booster immunogenicity and safety study in children previously vaccinated with Pentaxim
2015-005403-87Phase 4
Key facts
- Start
- Dec 2015
- Countries
- 1
- Sponsor
- Sanofi
- Modality
- Vaccines & Immunotherapeutics
- Conditions
- diphtheriaTetanuspertussispoliomyelitis
01
Overview
Phase 4, single-arm trial of diphtheria toxoid + tetanus toxoid + acellular pertussis in diphtheria, Tetanus, pertussis and 1 more, sponsored by Sanofi. Primary endpoint: Post-booster seroprotection and vaccine response at one month.
02
Design
1 arm- Study design
- Non-randomizedSingle group
Tetraxim booster
Single-group arm receiving a booster dose of Tetraxim after prior Pentaxim vaccination
03
Who it enrols
Healthy children 4 to 6 years of age who had previously been vaccinated with Pentaxim in study E2I34 and were eligible to receive a Tetraxim booster dose.
04
Endpoints
Primary
Post-booster seroprotection and vaccine response at one month
Secondary
Immunogenicity
Safety
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