To evaluate the efficacy and safety of vaccinating children and adolescents, aged 3 to 17years, with a two-dose schedule of the inactivated vaccine (Coronavac) againstSARS-Cov-2.
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.
Biological: Inactivated Coronavac/Butantan vaccine
Inactivated Coronavac/Butantan vaccine in 2 doses of 0.5 ml, 4 weeks apart
Biological: BNT162b2 (Pfizer)
BNT162b2 (Pfizer) vaccine in 2 doses of 0.1 ml or 0.30 ml (according to age group), 4
weeks apart
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).
Valéria Valim
Vitória, Espírito Santo, Brazil
Investigator: Valeria Valim, PhD
Contact: +55 27 3315-7899
val.valim@gmail.com
Not Provided