Trial intelligence / Profile preview

Safety of 20-valent Pneumococcal Conjugate Vaccine in Healthy Infants

NCT04379713Phase 3

Key facts

Status: Completed
Start: May 2020
Primary completion: Aug 2022
Countries: 11
Sponsor: Pfizer
Modality: Vaccines & Immunotherapeutics

Drugs: Prevnar 20
Conditions: pneumococcal disease

Overview

Phase 3, randomised, double-blind trial of Prevnar 20 in pneumococcal disease (2 arms), sponsored by Pfizer. Primary endpoints: Percentage of Participants With Local Reactions Within 7 Days After Dose 1, Percentage of Participants With Local Reactions Within 7 Days After Dose 2 and 10 more. Started May 2020; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

20vPnC
20-valent pneumococcal conjugate vaccine
13vPnC
13-valent pneumococcal conjugate vaccine

Who it enrols

Healthy male or female infants aged 2 months (42-98 days) born at ≥34 weeks gestation.

Endpoints

Primary

Percentage of Participants With Local Reactions Within 7 Days After Dose 17 days post-dose 1
Percentage of Participants With Local Reactions Within 7 Days After Dose 27 days post-dose 2
Percentage of Participants With Local Reactions Within 7 Days After Dose 37 days post-dose 3
Percentage of Participants With Local Reactions Within 7 Days After Dose 47 days post-dose 4
Percentage of Participants With Systemic Events Within 7 Days After Dose 17 days post-dose 1

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