NCT05354024View on ClinicalTrials.gov

Phase II/III Randomized Clinical Trial of Booster Dose of COVID-19 (Recombinant, Inactivated) Vaccine

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

4,400

Participants

Timeline

Start Date

February 28, 2023

Primary Completion Date

October 5, 2023

Study Completion Date

September 25, 2024

Conditions
Coronavirus InfectionsHealthy
Interventions
BIOLOGICAL

NDV-HXP-S 10μg

NDV-HXP-S 10μg/0.5mL intramuscular (deltoid), 1 dose (booster)

BIOLOGICAL

BNT162b2 30μg

Vaccine against COVID-19 BNT162b2 30μg/0.3mL intramuscular (deltoid), 1 dose (booster)

Trial Locations (6)

50670-420

Instituto Aggeu Magalhães - Fundação Osvaldo Cruz - Pernambuco, Recife

09530-905

Universidade Municipal de São Caetano do Sul, São Caetano do Sul

14150-000

Centro de Pesquisa Clínica S, Serrana

13271-130

Azidus Brasil Pesquisa Científica e Desenvolvimento Ltda., Valinhos

27258-000

Instituto Lóbus, Volta Redonda

20241-180

Instituto Brasil de Pesquisa Clínica (IBPClin), Rio de Janeiro

Sponsors

Lead Sponsor

Butantan Institute
All Listed Sponsors
lead

Butantan Institute

OTHER_GOV