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Safety and Immunogenicity of 20vPnC in Toddlers With 2 Prior Doses of Prevenar 13
NCT05408429Phase 3
Key facts
- Status
- Completed
- Start
- Jun 2022
- Primary completion
- Jun 2023
- Countries
- 3
- Sponsor
- Pfizer
- Modality
- Vaccines & Immunotherapeutics
- Drugs
- Prevnar 20
- Conditions
- pneumococcal disease
01
Overview
Phase 3, randomised, double-blind trial of Prevnar 20 in pneumococcal disease (3 arms), sponsored by Pfizer. Primary endpoints: Percentage of Participants With Local Reactions Within 7 Days After Last Vaccination, Percentage of Participants With Systemic Events Within 7 Days After Last Vaccination and 3 more. Started Jun 2022; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
2-Dose 20vPnC Group
Received 2 doses of 20vPnC approx. 2 months apart
1-Dose 20vPnC Group
Received 1 dose of 20vPnC
13vPnC Group
Received 1 dose of Prevnar 13 (Active Control)
03
Endpoints
Primary
Percentage of Participants With Local Reactions Within 7 Days After Last Vaccination
Percentage of Participants With Systemic Events Within 7 Days After Last Vaccination
Percentage of Participants With Adverse Events (AEs)
Percentage of Participants With Serious Adverse Events (SAEs)
Percentage of Participants With Predefined Serotype-Specific IgG Concentrations for the 7 Additional Serotypes
Secondary
Serotype-specific IgG Geometric Mean Concentrations (GMC)
Percentage of Participants With Predefined IgG Concentrations for the 13 Matched Serotypes
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs)
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