NCT04560881

Brief Summary

This is a randomized, double blind, placebo parallel-controlled phase III clinical trial to evaluate the efficacy, immunogenicity and safety of the inactivated SARS-CoV-2 Vaccine (Vero cell) in Argentine healthy population aged between 18 and 85 years old.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2020

Shorter than P25 for phase_3

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

September 16, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 23, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2021

Completed
Last Updated

January 12, 2022

Status Verified

January 1, 2022

Enrollment Period

1.2 years

First QC Date

September 16, 2020

Last Update Submit

January 11, 2022

Conditions

COVID-19 Virus Infection

Keywords

COVID-19SARS-CoV-2 infectionInactivated SARS-CoV-2 Vaccine

Outcome Measures

Primary Outcomes (1)

  • Incidence of COVID-19 cases after two-doses of vaccination

    All confirmed COVID -19 cases 14 days after the full course of vaccination among healthy population aged between 18 and 85 years old.

    14 days after the full course of vaccination

Secondary Outcomes (6)

  • The 4-fold increase rate of anti-SARS-CoV-2 neutralizing antibody

    14 days after 2-dose of immunization and 28 days after full course of immunization

  • The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody

    14 days after 2-dose of immunization and 28 days after full course of immunization

  • The Geometric Mean Increase (GMI) of anti-SARS-CoV-2 neutralizing antibody

    14 days after 2-dose of immunization and 28 days after full course of immunization

  • Incidence of any adverse reactions/events

    Within 30 minutes after each dose of vaccine

  • Incidence of adverse reactions/events

    0 ~ 21/28 days after each dose of vaccine

  • +1 more secondary outcomes

Other Outcomes (1)

  • Anti-SARS-CoV-2 neutralizing antobody (NtAb) (immunological surrogate endpoint)

    14 days after 2-dose of immunization.

Study Arms (2)

Inactivated SARS-CoV-2 vaccine, manufactured by BIBP

EXPERIMENTAL

Intramuscular injection

Biological: Inactivated SARS-CoV-2 vaccine (Vero cell)

Placeboof Inactivated SARS-CoV-2 vaccine, manufactured by BIBP

PLACEBO COMPARATOR

Intramuscular injection

Biological: Placebo/Aluminum Adjuvant of Inactivated SARS-CoV-2 vaccine

Interventions

Inactivated SARS-CoV-2 vaccine (Vero cell)BIOLOGICAL

Immunization schedule: 2-doses of investigational vaccine or placebo are inoculated to the deltoid muscle of the upper arm according to the immunization schedule of Day 0, 21.

Inactivated SARS-CoV-2 vaccine, manufactured by BIBP
Placebo/Aluminum Adjuvant of Inactivated SARS-CoV-2 vaccineBIOLOGICAL

Immunization schedule: 2-doses of investigational vaccine or placebo are inoculated to the deltoid muscle of the upper arm according to the immunization schedule of Day 0, 21.

Placeboof Inactivated SARS-CoV-2 vaccine, manufactured by BIBP

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy subjects aged between 18 and 85 years old.
  • By asking for medical history and physical examination, the investigator judged that the health condition is well.
  • During the whole follow-up period of the study, be able and willing to complete the whole prescribed study plan.
  • With self-ability to understand the study procedures, the informed consent \& voluntarily sign an informed consent form and be able to comply with the requirements of the protocol.

You may not qualify if:

  • Active Sars-Cov-2 Infection measured by RT-qPCR
  • Has a history of SARS, MERS infection (self-report, on-site inquiry)
  • Has clinical manifestation of fever (axillary temperature \> 37.0 ℃), dry cough, fatigue, nasal obstruction, runny nose, pharyngeal pain, myalgia, diarrhea, shortness of breath and dyspnea occurred within 14 days before vaccination.
  • Body temperature \> 37.0 ℃ before vaccination
  • Urine pregnancy test positive;
  • Previous severe allergic reactions to vaccination (such as acute allergic reactions, urticaria, dyspnea, angioneurotic edema or abdominal pain) or allergy to known ingredients of inactivated SARS-CoV-2 vaccine have occurred.
  • Has a history of convulsion, epilepsy, encephalopathy or mental illness or family history.
  • With congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
  • With severe liver and kidney diseases, uncontrollable hypertension (systolic blood pressure ≥ 140 mmHg, diastolic blood pressure ≥ 90 mmHg), diabetic complications, malignant tumors, various acute diseases, or acute attack period of chronic diseases.
  • Has been diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia, or other autoimmune diseases.
  • With known or suspected diseases include severe respiratory diseases, severe cardiovascular diseases, liver and kidney diseases, and malignant tumors.
  • Has a history of coagulation dysfunction (e.g. Coagulation factor deficiency, coagulation disease)
  • Receiving anti-TB therapy.
  • Patients receiving immunotherapy or inhibitor therapy within 3 months (continuous oral or infusion for more than 14 days)
  • Inoculated live attenuated vaccines within 1 month before this vaccination, other vaccines are inoculated within 14 days before this vaccination.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Fundación Huésped

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1202ABB, Argentina

Location

Vacunar Liniers

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1408FVD, Argentina

Location

Vacunar Cañitas

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426BOF, Argentina

Location

Vacunar Coghlan

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1430BKB, Argentina

Location

MeSH Terms

Conditions

COVID-19

Interventions

SARS-CoV-2 inactivated vaccines

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Clinical trial conducted in randomized, double-blinded, placebo-controlled design.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2020

First Posted

September 23, 2020

Study Start

September 16, 2020

Primary Completion

December 13, 2021

Study Completion

December 13, 2021

Last Updated

January 12, 2022

Record last verified: 2022-01

Locations

AR(4)