This is a multicenter, randomized, and open-label study to evaluate the immune responses and safety profiles of children aged 6-12 years and adolescents aged 13-17 years receiving Ad5-nCoV (intramuscular injection) or Ad5-nCoV-IH (nebulized inhalation) ≥ 90 days after receiving two doses of CoronaVac.
A total of 1000 participants will be equally divided into the two study groups, children of 6-12 years and adolescents of 13-17 years. In each age group, they will have an equal chance to received either one dose of Ad5-nCoV (intramuscular injection) or Ad5-nCoV-IH (nebulized inhalation). The enrollment of the children group will start after the safety profiles in 7 days post-vaccination of the adolescent group have been deemed acceptable. Investigators should try to balance the age and sex of the participants during enrollment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
91
Intramuscular injection
Nebulized inhalation through the mouth
Hospital Base de Osorno
Osorno, Los Lagos Region, Chile
Hospital Carlos van Buren
Valparaíso, Región de Valparaíso, Chile
Incidence of SAE
Evaluate the incidence of severe adverse events (SAE)
Time frame: Day 0 to 12 months post IM or IH
Immunogenicity of S-RBD IgG antibody
GMC of S-RBD IgG antibody by Elisa post vaccination
Time frame: 28 days post IM or IH
Incidence of Adverse Reactions (ARs)
Incidence of solicited adverse reactions (ARs)
Time frame: Within 14 days post IM or IH
The incidence of AR and AE
Incidence of AR and AE within 28 days
Time frame: Within 28 days post IM or IH
Immunogenicity of S-RBD IgG antibody
GMC of S-RBD IgG antibody post vaccination by ELISA
Time frame: 14 days post IM or IH
Immunogenicity of S-RBD IgG antibody
Seroconversion rate of S-RBD IgG antibody post vaccination by ELISA
Time frame: 14 and 28 days post IM or IH
Immunogenicity of S-RBD IgG antibody
GMI of S-RBD IgG antibody post vaccination by ELISA
Time frame: 14 and 28 days post IM or IH
Immunogenicity of S-RBD IgG antibody
GMT of pseudo-virus neutralizing antibody by ELISA
Time frame: 14 and 28 days post IM or IH
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Immunogenicity of S-RBD IgG antibody
GMI of pseudo-virus neutralizing antibody by ELISA
Time frame: 14 and 28 days post IM or IH
Immunogenicity of S-RBD IgG antibody
Seroconversion rate of pseudo-virus neutralizing antibody by ELISA
Time frame: 14 and 28 days post IM or IH