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

Federal University of Espirito Santo

Status and phase: Unknown; Phase 3

Conditions: COVID-19

Treatments: Biological: BNT162b2 (Pfizer); Biological: Inactivated Coronavac/Butantan vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT05225285

FUES04

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,120 estimated patients

Sex: All

Ages: 3 to 49 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,120 participants in 3 patient groups

VACC

Experimental group

Description:

This group will receive the inactivated Coronavac/Butantan vaccine.

Treatment:

Biological: Inactivated Coronavac/Butantan vaccine

BNTC

Active Comparator group

Description:

This group will receive the immunizing BNT162b2 (Pfizer).

Treatment:

Biological: BNT162b2 (Pfizer)

ADU

Active Comparator group

Description:

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

Treatment:

Biological: Inactivated Coronavac/Butantan vaccine