Evaluate the Safety and Immunogenicity of Ad5 COVID-19 Vaccines for Booster Use in Children Aged 6-17 Years.
NCT05330871 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 410
Last updated 2023-04-13
Summary
This is a single center, open-label, parallel controlled, and randomized Phase II clinical trial to evaluate the safety and immunogenicity of two types of Recombinant Novel Corona Virus Vaccine (Adenovirus type 5 vector) in population aged 6-17 years who have been previously immunized with 2 doses of inactivated COVID-19 vaccine. This is to evaluate the safety and immunogenicity of different heterologous prime-boost regimen in this population.
Conditions
Interventions
- BIOLOGICAL
-
1 Nebulized inhalation for booster groups
Ad5-nCoV-IH, 1 dose 0.1ml
- BIOLOGICAL
-
2 Nebulized inhalation for booster groups
Ad5-nCoV-IH, 1 dose 0.1ml
- BIOLOGICAL
-
3 Nebulized inhalation for booster groups
Ad5-nCoV-IH, 1 dose 0.1ml
- BIOLOGICAL
-
4 Nebulized inhalation for booster groups
Ad5-nCoV-IH, 1 dose 0.1ml
- BIOLOGICAL
-
5 Intramuscular injection for booster groups
Ad5-nCoV-IM, 1 dose 0.3ml
- BIOLOGICAL
-
6 Intramuscular injection for booster groups
Ad5-nCoV-IM, 1 dose 0.3ml
- BIOLOGICAL
-
7 Intramuscular injection for booster groups
Ad5-nCoV-IM, 1 dose 0.3ml
- BIOLOGICAL
-
8 Intramuscular injection for booster groups
ICV, 1 dose 0.5ml
- BIOLOGICAL
-
9 Intramuscular injection for booster groups
ICV, 1 dose 0.5ml
- BIOLOGICAL
-
10 Intramuscular injection for booster groups
1 dose 0.5ml
- BIOLOGICAL
-
11 Nebulized inhalation for booster groups
Ad5-nCoV-IH, 1 dose 0.1ml
- BIOLOGICAL
-
12 Nebulized inhalation for booster groups
Ad5-nCoV-IH, 1 dose 0.1ml
- BIOLOGICAL
-
13 Nebulized inhalation for booster groups
Ad5-nCoV-IH, 1 dose 0.1ml
- BIOLOGICAL
-
14 Nebulized inhalation for booster groups
Ad5-nCoV-IH, 1 dose 0.1ml
- BIOLOGICAL
-
15 Intramuscular injection for booster groups
Ad5-nCoV-IM, 1 dose 0.3ml
- BIOLOGICAL
-
16 Intramuscular injection for booster groups
Ad5-nCoV-IM, 1 dose 0.3ml
- BIOLOGICAL
-
17 Intramuscular injection for booster groups
Ad5-nCoV-IM, 1 dose 0.3ml
- BIOLOGICAL
-
18 Intramuscular injection for booster groups
ICV, 1 dose 0.5ml
- BIOLOGICAL
-
19 Intramuscular injection for booster groups
ICV, 1 dose 0.5ml
- BIOLOGICAL
-
20 Intramuscular injection for booster groups
ICV, 1 dose 0.5ml
- BIOLOGICAL
-
21 Nebulized inhalation for primary groups
Ad5-nCoV-IH, 2 doses 0.1ml
- BIOLOGICAL
-
22 Nebulized inhalation for primary groups
Ad5-nCoV-IH, 2 doses 0.1ml
- BIOLOGICAL
-
23 Nebulized inhalation for primary groups
Ad5-nCoV-IH, 2 doses 0.1ml
- BIOLOGICAL
-
24 Nebulized inhalation for primary groups
Ad5-nCoV-IH, 2 doses 0.1ml
Sponsors & Collaborators
-
Seventh Medical Center of PLA General Hospital
lead OTHER
Principal Investigators
-
Chen Dong · Seventh Medical Center of PLA General Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Years
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-04-17
- Primary Completion
- 2022-06-30
- Completion
- 2023-05-30
Countries
- China
Study Locations
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