A Study to Evaluate the Safety and Immunogenicity of Ad5-nCoV and Ad5-nCoV-IH in CoronaVac Immunized Children and Adolescents

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-25

Study Completion Date

2023-01-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Lot-to-lot Consistency of an Inactivated SARS-CoV-2 Vaccine Between Different Workshops in Healthy Children Aged 3-17 Years

NCT05112913

COVID-19

ACTIVE_NOT_RECRUITING PHASE4

A Study to Learn About Variant-Adapted COVID-19 RNA Vaccine Candidate(s) in Healthy Children

NCT05543616

SARS-CoV-2 Virus Severe Acute Respiratory Syndrome Coronavirus 2 COVID-19

RECRUITING PHASE2/PHASE3

A Study to Evaluate Different Dose Levels of Ad26.COV2.S in Healthy Adolescents From 12 to 17 Years Inclusive

NCT05007080

Coronavirus Disease-2019 (COVID-19) Prevention

COMPLETED PHASE2

A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children

NCT04816643

SARS-CoV-2 Infection, COVID-19

COMPLETED PHASE2/PHASE3

SARS-CoV-2 Antibody Response in Children Aged 5-11 Years Following Vaccination Against COVID-19

NCT05175989

COVID-19 Vaccine

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COVID-19

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Vaccine Group

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.

Group Type EXPERIMENTAL

Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

Intervention Type BIOLOGICAL

Intramuscular injection

Recombinant COVID-19 vaccine (adenovirus type 5 vector) for Inhalation (Ad5-nCoV-IH)

Intervention Type BIOLOGICAL

Nebulized inhalation through the mouth

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

Intramuscular injection

Intervention Type BIOLOGICAL

Recombinant COVID-19 vaccine (adenovirus type 5 vector) for Inhalation (Ad5-nCoV-IH)

Nebulized inhalation through the mouth

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Children aged 6-12 years and adolescents aged 13-17 years at the time of randomization.
2. Have received a complete two dose schedule of CoronaVac for ≥ 90 days.
3. Obtain written informed assent from participants and consent from parents, guardians or legal representatives.
4. Subjects are eligible for immunization of this product as evaluated by investigators after medical history examination, physical examination and clinical judgment of health.

Exclusion Criteria

1. Have a history of seizures, epilepsy, encephalopathy, psychosis.
2. History of anaphylaxis to any vaccine component.
3. Positive urine pregnancy test result, pregnant, lactation women. Female had menarche must conduct the urine pregnancy test.
4. Congenital or acquired angioedema/neuroedema .
5. Medical history of Guillain-Barré syndrome.
6. Have had asthma attacks within 2 years.
7. Have severe nasal or oral diseases, such as rhinitis (sinusitis), allergic rhinitis, oral ulcer, throat swelling, etc.
8. Asplenia or functional absence of spleen.
9. Bleeding disorder (e.g. protein S or factor deficiency, coagulopathy or platelet disorder).
10. Any confirmed or suspected immunosuppressive or immunodeficient state; received immunosuppressive therapy, cytotoxic therapy, or chronic corticosteroids (excluding corticosteroid spray therapy for allergic rhinitis and surface corticosteroid therapy for acute non-complicated dermatitis) within the past 6 months.
11. Have chronic systematic infection or chronic pulmonary disease
12. Administration of immunoglobulins and/or any blood products within three months prior to the planned administration of the vaccine candidate.
13. Receiving anti-tuberculosis or cancer treatment.
14. History of COVID-19 disease.
15. Have a positive result at the examination of rapid SARS-CoV-2 antibody assay (S-RBD IgG) before vaccination.
16. Have received COVID vaccines other than CoronaVac.
17. Received or plan to receive any non-COVID vaccines (licensed or investigational), within 14 days before and after study vaccination.
18. Current diagnosis of or treatment for cancer, e.g. leukemia.
19. Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, and affect the ability of the volunteer to participate in the study or impair interpretation of the study data.

Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes