NCT04951388

A Study to Evaluate MVC-COV1901 Vaccine Against COVID-19 in Adolescents

A Phase II, Prospective, Double-blinded, Multi-Center Study to Evaluate the Safety, Tolerability, and Immunogenicity of the SARS CoV 2 Vaccine Candidate MVC COV1901 in Adolescents

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 399 (actual)
• Sponsor: Medigen Vaccine Biologics Corp. · Industry
• Sex: All
• Age: 12 Years – 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the safety and immunogenicity of MVC-COV1901 vaccine compared to placebo in participants aged ≥ 12 to \< 18 years.

Detailed description

This is a Phase II, prospective, placebo-controlled, double-blinded (investigator/site staff and participants), multi-center study; the Sponsor will be blinded until the interim analysis. Participants aged ≥ 12 to \< 18 years will be enrolled. All eligible participants will be randomized to receive either MVC-COV1901 or placebo in a 6:1 ratio.

Conditions

• Covid19 Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	MVC-COV1901(S protein with adjuvant)	Approximately 330 participants will receive 2 doses of MVC-COV1901(S-2P protein with adjuvant) at Visit 2 (Day 1) and Visit 4 (Day 29) via intramuscular (IM) injection in the deltoid region
BIOLOGICAL	MVC-COV1901(Saline)	Approximately 55 participants will receive 2 doses of MVC-COV1901(Saline) at Visit 2 (Day 1) and Visit 4 (Day 29) via IM injection in the deltoid region

Timeline

• Start date: 2021-07-22
• Primary completion: 2021-10-25
• Completion: 2022-03-21
• First posted: 2021-07-06
• Last updated: 2022-04-20

Locations

5 sites across 1 country: Taiwan