Efficacy, Immunogenicity and Safety of Inactivated Vaccine (Coronavac) Against SARS-COV2 in Children and Adolescents

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

1120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-21

Study Completion Date

2023-03-21

Brief Summary

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To evaluate the efficacy and safety of vaccinating children and adolescents, aged 3 to 17 years, with a two-dose schedule of the inactivated vaccine (Coronavac) against SARS-Cov-2.

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Detailed Description

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Nine hundred sixty (960) participants will be randomized into 2 groups, in a 2:1 ratio, to receive the inactivated Coronavac/Butantan vaccine (VACC, N=640) and a group to receive the immunizing BNT162b2 (Pfizer) (BNTC, N=320). The VACC group will also be compared to a group of adults aged 18 to 49 who received Coronavac (ADU, N=160). The main outcome will be the geometric title of neutralizing antibodies and the secondary outcomes will be the incidence of the number of cases confirmed by RT-PCR, the cellular immune response and frequency of adverse events. Outcomes will be evaluated before the first dose, and 28 and 90 days after the second dose, and followup after 6 and 12 months. The study hypothesis is that the cellular and humoral immune response of children and adolescents is not inferior to the age group 18 to 49 years, who received Coronavac and compared to children vaccinated with the immunizing BNT162b2 (Pfizer) and that the inactivated vaccine presents lower reactogenicity for the age group studied.

Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomized into 2 groups, in a 2:1 ratio, to receive the inactivated Coronavac/Butantan vaccine (VACC) and a group to receive the immunizing BNT162b2 (Pfizer) (BNTC). The VACC group will also be compared to a group of adults aged 18 to 49 who received Coronavac (ADU).

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

For blinding, the vaccine dose will be prepared by a pharmacist, who will be the only one who will know which immunizer will be administered. Vaccinators, participants and evaluators will not know which immunizer will be given.

Study Groups

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VACC

This group will receive the inactivated Coronavac/Butantan vaccine.

Group Type EXPERIMENTAL

Inactivated Coronavac/Butantan vaccine

Intervention Type BIOLOGICAL

Inactivated Coronavac/Butantan vaccine in 2 doses of 0.5 ml, 4 weeks apart

BNTC

This group will receive the immunizing BNT162b2 (Pfizer).

Group Type ACTIVE_COMPARATOR

BNT162b2 (Pfizer)

Intervention Type BIOLOGICAL

BNT162b2 (Pfizer) vaccine in 2 doses of 0.1 ml or 0.30 ml (according to age group), 4 weeks apart

ADU

This group of adults participants will receive the inactivated Coronavac/Butantan vaccine.

Group Type ACTIVE_COMPARATOR

Inactivated Coronavac/Butantan vaccine

Intervention Type BIOLOGICAL

Inactivated Coronavac/Butantan vaccine in 2 doses of 0.5 ml, 4 weeks apart

Interventions

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Inactivated Coronavac/Butantan vaccine

Inactivated Coronavac/Butantan vaccine in 2 doses of 0.5 ml, 4 weeks apart

Intervention Type BIOLOGICAL

BNT162b2 (Pfizer)

BNT162b2 (Pfizer) vaccine in 2 doses of 0.1 ml or 0.30 ml (according to age group), 4 weeks apart

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Age between 3 and 17 years old (VACC and BNTC groups)
* Age between 18 and 49 years old (ADU group)

Exclusion Criteria

* Pregnant teenagers;
* History of severe allergic reaction (anaphylaxis, urticaria or angioedema) to any previously administered vaccine;
* Have previously received a vaccine against COVID-19;
* Personal history of SARS-CoV-2-related Multisystem Inflammatory Syndrome (MIS-C);
* Immunosuppressed due to conditions such as inborn error of metabolism, HIV infection, neoplasia or use of immunosuppressive drugs (systemic corticosteroids for more than 14 days or another immunosuppressant).

Minimum Eligible Age

3 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes