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Difficulty recruiting subjects, so the study was terminated.
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| Name | Class |
|---|---|
| Beijing Institute of Biotechnology | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaccine Group | Experimental | 1000 participants,500 children aged 6-12 years and 500 adolescents aged 13-17 years, Ad5-nCoV or Ad5-nCoV-IH, ≥90 days after two doses of CoronaVac. Intramuscular injection or nebulized inhalation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) | Biological | Intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of SAE | Evaluate the incidence of severe adverse events (SAE) | 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 | 28 days post IM or IH |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Reactions (ARs) | Incidence of solicited adverse reactions (ARs) | Within 14 days post IM or IH |
| The incidence of AR and AE | Incidence of AR and AE within 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of booster vaccination | The number of all COVID-19 cases after vaccination | Up to 12 months post IM or IH |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephania Passalacqua | Hospital Base de Osorno, Chile | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Base de Osorno | Osorno | Los Lagos Region | Chile | |||
| Hospital Carlos van Buren |
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| Recombinant COVID-19 vaccine (adenovirus type 5 vector) for Inhalation (Ad5-nCoV-IH) | Biological | Nebulized inhalation through the mouth |
|
| Within 28 days post IM or IH |
| Immunogenicity of S-RBD IgG antibody | GMC of S-RBD IgG antibody post vaccination by ELISA | 14 days post IM or IH |
| Immunogenicity of S-RBD IgG antibody | Seroconversion rate of S-RBD IgG antibody post vaccination by ELISA | 14 and 28 days post IM or IH |
| Immunogenicity of S-RBD IgG antibody | GMI of S-RBD IgG antibody post vaccination by ELISA | 14 and 28 days post IM or IH |
| Immunogenicity of S-RBD IgG antibody | GMT of pseudo-virus neutralizing antibody by ELISA | 14 and 28 days post IM or IH |
| Immunogenicity of S-RBD IgG antibody | GMI of pseudo-virus neutralizing antibody by ELISA | 14 and 28 days post IM or IH |
| Immunogenicity of S-RBD IgG antibody | Seroconversion rate of pseudo-virus neutralizing antibody by ELISA | 14 and 28 days post IM or IH |
| Valparaíso |
| Valparaiso |
| Chile |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D053120 | Respiratory Aspiration |
| C566578 | Alzheimer Disease 5 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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