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Available in the Gosset platform where reported.
01
Overview
Phase 2, randomised, double-blind trial of SP0173 in Tetanus, diphtheria and pertussis (18 arms), sponsored by Sanofi. Primary endpoint: Number of Participants With Solicited Injection Site or Systemic Reactions. Started Oct 2015; status: completed.
02
Design
18 arms- Study design
- RandomizedDouble-blind
Adolescents: SP0173 F1
Adolescents receiving SP0173 Formulation 1
Adolescents: SP0173 F2
Adolescents receiving SP0173 Formulation 2
Adolescents: SP0173 F3
Adolescents receiving SP0173 Formulation 3
Adolescents: SP0173 F4
Adolescents receiving SP0173 Formulation 4
Adolescents: Adacel
Adolescents receiving Adacel
Adolescents: Boostrix
Adolescents receiving Boostrix
12 more in the full profile.
03
Who it enrols
Healthy adolescents (10-18), adults (19-64), and older adults (>=65) with no recent vaccination or history of adverse reactions to Tdap vaccines.
04
Endpoints
Primary
Number of Participants With Solicited Injection Site or Systemic Reactions
Secondary
Immunogenicity of SP0173 investigational formulations
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Competitive context
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