A Phase III Clinical Study of a SARS-CoV-2 Messenger Ribonucleic Acid (mRNA) Vaccine Candidate Against COVID-19 in Population Aged 18 Years and Above

PHASE3UnknownINTERVENTIONAL
Enrollment

28,000

Participants

Timeline

Start Date

July 22, 2021

Primary Completion Date

November 30, 2021

Study Completion Date

May 30, 2023

Conditions
COVID-19SARS-CoV-2
Interventions
BIOLOGICAL

SARS-CoV-2 mRNA Vaccine

"The SARS-CoV-2 mRNA Vaccine is formulated by encapsulating the mRNA, which encodes the receptor-binding domain (RBD) of spike glycoprotein (S protein) of SARS-CoV-2 and is transcribed in-vitro by the corresponding DNA template, in lipid nanoparticles (LNPs). This vaccine is presented as a white to off-white dispersion for injection.~Active substances: mRNA encoding the RBD of the S protein of SARS-CoV-2.~The vaccine is supplied in single-dose pre-filled syringe with 0.5 mL dispersion for intramuscular injection. Each dose (0.5 mL) of the vaccine contains:~15 μg of mRNA encoding the RBD of the spike glycoprotein (S protein) of SARS-CoV-2, 0.339 mg of total lipids (including lipid 9001, cholesterol, DSPC, DMG-PEG2000)."

BIOLOGICAL

Placebo

0.9% sodium chloride solution, 0.5 mL/vial

Trial Locations (12)

Unknown

RECRUITING

Persahabatan Hospital, Jakarta

RECRUITING

Puskesmas Duren Sawit, Jakarta

RECRUITING

Puskesmas Kalideres, Jakarta

RECRUITING

Puskesmas Kebayoran Lama, Jakarta

RECRUITING

Puskesmas Pulogadung, Jakarta

RECRUITING

Centro de Investigación Clínica del Pacifico S.A. de C.V. (CICPA), Acapulco

RECRUITING

Centro de Investigación y Avances Médicos Especializados (CIAME), Cancún

RECRUITING

Centro de Especialidades Médicas Aplicadas, Mexico City

RECRUITING

Instituto Nacional de Pediatría (INP), Mexico City

RECRUITING

Oaxaca site management organization (OSMO), Oaxaca City

RECRUITING

Asociación Mexicana para la investigación clínica, A.C. (AMIC), Pachuca

RECRUITING

Oncológico Potosino, San Luis Potosí City

Sponsors
All Listed Sponsors
collaborator

Abogen Biosciences Co. Ltd.

INDUSTRY

collaborator

Yuxi Walvax Biotechnology Co., Ltd.

UNKNOWN

lead

Walvax Biotechnology Co., Ltd.

INDUSTRY

NCT04847102 - A Phase III Clinical Study of a SARS-CoV-2 Messenger Ribonucleic Acid (mRNA) Vaccine Candidate Against COVID-19 in Population Aged 18 Years and Above | Biotech Hunter | Biotech Hunter