NCT05308602

A Study to Evaluate the Immunogenicity and Safety of SCTV01C and SCTV01E (Two Recombinant Protein COVID-19 Vaccines) in Population Aged ≥12 Years

A Randomized, Double-blinded, Active-controlled Phase II Clinical Study to Evaluate the Immunogenicity and Safety of SCTV01C (A Bivalent SARS-CoV-2 Trimeric Spike Protein Vaccine) and SCTV01E (A COVID-19 Alpha/Beta/Delta/Omicron Variants S-Trimer Vaccine) in Population Aged ≥12 Years and Previously Unvaccinated

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sinocelltech Ltd. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Accepted

Summary

The objective of the study is to evaluate the immunogenicity and safety of SCTV01C or SCTV01E, comparing the immunogenicity data against Beta (B.1.351), Delta (B.1.617.2), Omicron (B.1.1.529) and other variants with Sinopharm inactivated COVID-19 vaccine or mRNA vaccine.

Detailed description

The study is a randomized, double-blinded, active-controlled (Approved vaccine) Phase II clinical study. The study consists of 2 stages, Stage 1 and 2. In Stage 1, participants would randomly receive 2 doses of SCTV01C, SCTV01E, Sinopharm COVID-19 vaccine or mRNA vaccine on Day 0 and Day 28. Stage 1 is aimed to evaluate the immunogenicity and safety of SCTV01C or SCTV01E, comparing the immunogenicity data against Beta (B.1.351), Delta (B.1.617.2), Omicron (B.1.1.529) and other variants after the 2nd dose of vaccination with Sinopharm inactivated COVID-19 vaccine or mRNA vaccine. Stage 2 will start on Day 180 and the participants will receive a 3rd dose of vaccination.

Conditions

• COVID-19
• SARS-CoV-2 Infection

Interventions

Type	Name	Description
BIOLOGICAL	SCTV01C	Day 0; intramuscular injection
BIOLOGICAL	SCTV01C	Day 28; intramuscular injection
BIOLOGICAL	SCTV01C	Day 180; intramuscular injection
BIOLOGICAL	SCTV01E	Day 0; intramuscular injection
BIOLOGICAL	SCTV01E	Day 28; intramuscular injection
BIOLOGICAL	SCTV01E	Day 180; intramuscular injection
BIOLOGICAL	mRNA vaccine manufactured by Pfizer or Moderna	Day 0; intramuscular injection
BIOLOGICAL	mRNA vaccine manufactured by Pfizer or Moderna	Day 28; intramuscular injection
BIOLOGICAL	mRNA vaccine manufactured by Pfizer or Moderna	Day 180; intramuscular injection
BIOLOGICAL	Sinopharm inactivated COVID-19 vaccine	Day 0; intramuscular injection
BIOLOGICAL	Sinopharm inactivated COVID-19 vaccine	Day 28; intramuscular injection
BIOLOGICAL	Sinopharm inactivated COVID-19 vaccine	Day 180; intramuscular injection

Timeline

• Start date: 2022-04-01
• Primary completion: 2022-08-01
• Completion: 2023-08-01
• First posted: 2022-04-04
• Last updated: 2024-02-09