Efficacy,Immunogenicity and Safety of COVID-19 Vaccine , Inactivated Booster Dose in Adults Aged 18 Years and Above

NCT05156632 | Withdrawn Phase 3

• 1 other identifier: PRO-nCOV-3003
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a multi-center, case-driven, randomized, double-blinded, and placebo-controlled Phase Ⅲb clinical trial of COVID-19 Vaccine manufactured by Sinovac Research \& Development Co., Ltd.The purpose of this study is to evaluate the efficacy of the booster dose after two doses of CoronaVac® against RT-PCR confirmed symptomatic COVID-19 cases in participants aged 18 years and above.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Efficacy index -COVID-19 incidence

  COVID-19 incidence per 100 person-years of follow-up based on laboratory confirmed cases in participants aged 18 years and above, 6 months after booster dose

  6 months after booster dose

Secondary Outcomes (5)

• Efficacy index -Confirmed hospitalized/severe/death incidence of COVID-19

  6 months after booster dose

• Safety index-Local reactions

  Up to 7 days after booster dose

• Safety index-Systemic events

  Up to 7 days after booster dose

• Safety index-AEs

  Up to 28 days after booster dose

• Safety index-SAEs

  Up to 6 months after booster dose

Study Arms (3)

Medium-dose group

EXPERIMENTAL

4800 participants including 3400 participants aged 18-59 years ,1200 participants aged 60 years and above who have received 2 doses of CoronaVac® (medium-dose COVID-19 Vaccine) in an interval between 21-56 days will receive a booster dose of medium-dose COVID-19 Vaccine 5-8 months after their second dose.

Biological: Medium-dosage COVID-19 Vaccine,Inactivated

High-dose group

EXPERIMENTAL

4800 participants including 3400 participants aged 18-59 years,1200 participants aged 60 years and above who have received 2 doses of CoronaVac® (medium-dose COVID-19 Vaccine) in an interval between 21-56 days will receive a booster dose of high-dose COVID-19 Vaccine 5-8 months after their second dose.

Biological: High-dosage COVID-19 Vaccine,Inactivated

Placebo group

PLACEBO COMPARATOR

4800 participants including 3400 participants aged 18-59 years,1200 participants aged 60 years and above who have received 2 doses of CoronaVac® (medium-dose COVID-19 Vaccine) in an interval between 21-56 days will receive a booster dose of placebo 5-8 months after their second dose.

Biological: Placebo-comparator group

Interventions

Medium-dosage COVID-19 Vaccine,Inactivated BIOLOGICAL

The COVID-19 vaccine,inactivated was manufactured by Sinovac Research\& Development Co., Ltd..600SU Inactivated SARS-COV-2 virus in 0·5 mL of aluminium hydroxide solution per injection.

Also known as: Medium-dose CoronaVac®

Medium-dose group

High-dosage COVID-19 Vaccine,Inactivated BIOLOGICAL

The COVID-19 vaccine,inactivated was manufactured by Sinovac Research\& Development Co., Ltd.1200SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection.

Also known as: High-dose CoronaVac®

High-dose group

Placebo-comparator group BIOLOGICAL

The composition is aluminium hydroxide with no antigen ,0 SU/0.5 mL,The appearance of the placebo is consistent with the vaccine, which is a milky-white suspension.

Also known as: Placebo (aluminum hydroxide)

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults aged 18 years and above, who have received 2 prior doses of CoronaVac® with an interval between those doses of 21-56 days, with the second dose given 5-8 months prior to the day of vaccination in the present study;
• The participants are able to understand and sign the informed consent voluntarily;
• Female participants who have a negative pregnancy test on the day of vaccination, and not currently breastfeeding;
• Must be willing to provide verifiable identification (in accordance with the local regulations), has means to be contacted and to contact the investigator during the study.

You may not qualify if:

• History of confirmed infection of SARS-CoV-2 prior to randomization;
• Any prior administration of another investigational coronavirus vaccine or current/planned simultaneous participation in another interventional study to prevent or treat COVID-19;
• Allergy to vaccines or vaccine/placebo ingredients, and serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneurotic edema;
• Serious chronic disease, serious cardiovascular disease, hypertension and diabetes that cannot be controlled by drugs, hepatorenal disease, malignant tumor, etc;
• Acute central nervous system diseases such as encephalitis/myelitis, acute disseminating encephalomyelitis, and related disorders;
• Receipt of blood/plasma products or immunoglobulins in the past 3 months before vaccination;
• Participation in other studies involving study intervention within 30 days prior to vaccination;
• Receipt of attenuated live vaccines in the past 14 days prior to vaccination;
• Receipt of inactivated or subunit vaccines in the past 7 days prior to vaccination;
• Acute exacerbation or presentation of stable chronic diseases (including but not limited to asthma, migraine, gastrointestinal disorder, etc);
• Acute febrile illness with axillary temperature \>37.5°C on the day of vaccination; enrollment could be considered if the fever is absent for 72 hours prior to vaccination;
• According to the investigator's judgment, the participant has any other factors that might interfere with the results of the clinical trial or pose additional risk to the participant due to participation in the study

Sponsors & Collaborators

• Sinovac Research and Development Co., Ltd.: lead

MeSH Terms

Conditions

COVID-19

Interventions

sinovac COVID-19 vaccine; Aluminum Hydroxide

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Aluminum Compounds; Anions; Ions; Electrolytes

Study Officials

• Javed Khan, Master

  Rehman Medical Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2021
• First Posted: December 14, 2021
• Study Start: February 20, 2023
• Primary Completion: February 20, 2023
• Study Completion: February 20, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02