Official Title
A Single Center, Open-label, Parallel Controlled, Randomized Phase II Study to Evaluate the Safety and Immunogenicity of Ad5-nCoV-IM, Ad5-nCoV-IH or Inactivated COVID-19 Vaccine in Population 6 to 17 Years of Age
Brief Summary

This is a single center, open-label, parallel controlled, and randomized Phase IIclinical trial to evaluate the safety and immunogenicity of two types of RecombinantNovel Corona Virus Vaccine (Adenovirus type 5 vector) in population aged 6-17 years whohave been previously immunized with 2 doses of inactivated COVID-19 vaccine. This is toevaluate the safety and immunogenicity of different heterologous prime-boost regimen inthis population.

Detailed Description

Participants will be randomized into two age groups: children aged 6-12 years and
adolescents aged 13-17 years. Subjects who have previously been immunized with 2 doses of
inactivated COVID-19 vaccine will be randomized into the booster dose groups to receive
either 1 dose of 0.1ml inhaled Ad5- nCoV-IH, 1 dose of 0.3ml intramuscular Ad5-nCoV-IM or
1 dose of 0.5ml intramuscular inactivated vaccine ICV as activecomparator in a ratio of
3:1:1. Participants who have not received any COVID-19 vaccine previously will be
randomized into 2 primary dose age groups: children aged 6-12 years and adolescents aged
13-17 years to receive 2 doses of 0.1ml inhaled Ad5-nCoVIH. The first 5 subjects of each
age group will enter the sentinel group to receive Ad5-nCoV-IH and monitor for safety
before the rest of the enrollment process.

Active, not recruiting
COVID-19

Biological: 1 Nebulized inhalation for booster groups

Ad5-nCoV-IH, 1 dose 0.1ml
Other Name: Recombinant COVID-19 Vaccine for Inhalation

Biological: 2 Nebulized inhalation for booster groups

Ad5-nCoV-IH, 1 dose 0.1ml
Other Name: Recombinant COVID-19 Vaccine for Inhalation

Biological: 3 Nebulized inhalation for booster groups

Ad5-nCoV-IH, 1 dose 0.1ml
Other Name: Recombinant COVID-19 Vaccine for Inhalation

Biological: 4 Nebulized inhalation for booster groups

Ad5-nCoV-IH, 1 dose 0.1ml
Other Name: Recombinant COVID-19 Vaccine for Inhalation

Biological: 5 Intramuscular injection for booster groups

Ad5-nCoV-IM, 1 dose 0.3ml
Other Name: Recombinant Corona Virus Vaccine (Adenovirus Type 5 Vector)

Biological: 6 Intramuscular injection for booster groups

Ad5-nCoV-IM, 1 dose 0.3ml
Other Name: Recombinant Corona Virus Vaccine (Adenovirus Type 5 Vector)

Biological: 7 Intramuscular injection for booster groups

Ad5-nCoV-IM, 1 dose 0.3ml
Other Name: Recombinant Corona Virus Vaccine (Adenovirus Type 5 Vector)

Biological: 8 Intramuscular injection for booster groups

ICV, 1 dose 0.5ml
Other Name: Inactivated COVID-19 Vaccine

Biological: 9 Intramuscular injection for booster groups

ICV, 1 dose 0.5ml
Other Name: Inactivated COVID-19 Vaccine

Biological: 10 Intramuscular injection for booster groups

1 dose 0.5ml
Other Name: Inactivated COVID-19 Vaccine

Biological: 11 Nebulized inhalation for booster groups

Ad5-nCoV-IH, 1 dose 0.1ml
Other Name: Recombinant COVID-19 Vaccine for Inhalation

Biological: 12 Nebulized inhalation for booster groups

Ad5-nCoV-IH, 1 dose 0.1ml
Other Name: Recombinant COVID-19 Vaccine for Inhalation

Biological: 13 Nebulized inhalation for booster groups

Ad5-nCoV-IH, 1 dose 0.1ml
Other Name: Recombinant COVID-19 Vaccine for Inhalation

Biological: 14 Nebulized inhalation for booster groups

Ad5-nCoV-IH, 1 dose 0.1ml
Other Name: Recombinant COVID-19 Vaccine for Inhalation

Biological: 15 Intramuscular injection for booster groups

Ad5-nCoV-IM, 1 dose 0.3ml
Other Name: Recombinant Corona Virus Vaccine (Adenovirus Type 5 Vector)

Biological: 16 Intramuscular injection for booster groups

Ad5-nCoV-IM, 1 dose 0.3ml
Other Name: Recombinant Corona Virus Vaccine (Adenovirus Type 5 Vector)

Biological: 17 Intramuscular injection for booster groups

Ad5-nCoV-IM, 1 dose 0.3ml
Other Name: Recombinant Corona Virus Vaccine (Adenovirus Type 5 Vector)

Biological: 18 Intramuscular injection for booster groups

ICV, 1 dose 0.5ml
Other Name: Inactivated COVID-19 Vaccine

Biological: 19 Intramuscular injection for booster groups

ICV, 1 dose 0.5ml
Other Name: Inactivated COVID-19 Vaccine

Biological: 20 Intramuscular injection for booster groups

ICV, 1 dose 0.5ml
Other Name: Inactivated COVID-19 Vaccine

Biological: 21 Nebulized inhalation for primary groups

Ad5-nCoV-IH, 2 doses 0.1ml
Other Name: Recombinant COVID-19 Vaccine for Inhalation

Biological: 22 Nebulized inhalation for primary groups

Ad5-nCoV-IH, 2 doses 0.1ml
Other Name: Recombinant COVID-19 Vaccine for Inhalation

Biological: 23 Nebulized inhalation for primary groups

Ad5-nCoV-IH, 2 doses 0.1ml
Other Name: Recombinant COVID-19 Vaccine for Inhalation

Biological: 24 Nebulized inhalation for primary groups

Ad5-nCoV-IH, 2 doses 0.1ml
Other Name: Recombinant COVID-19 Vaccine for Inhalation

Eligibility Criteria

Inclusion Criteria:

- Participants aged 6-17 years at the time of enrollment.

- Obtain written informed assent from participants and consent from parents, guardians
or legal representatives.

- Able and willing to complete all the scheduled study procedures during the whole
study follow-up period of 12 months.

- Have not received any COVID-19 vaccines (for primary groups only).

Exclusion Criteria:

- Medical or family history of seizures, epilepsy, encephalopathy, and psychosis
disorders.

- History of allergies to any ingredient of Ad5-nCoV, history of serious allergic
reactions to any vaccine, history of allergies and asthma.

- History of vaccine related SAEs after receiving any COVID-19 vaccines.

- Positive urine pregnancy test result, females with child bearing potential (have had
menarche).

- Acute febrile diseases and infectious diseases, medical history of SARS
(SARS-CoV-1).

- Axillary temperature >37.0#.

- Serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial
infarction, severe hypertension and uncontrollable by medications.

- Severe chronic diseases or with advanced stage conditions which cannot be controlled
smoothly, such as diabetes, thyroid disease, etc.

- Congenital or acquired angioedema/neurological edema.

- Urticaria history within 1 year before receiving the study vaccine.

- Asplenia or functional aspleenia.

- Thrombocytopenia or other coagulation disorders (may cause contraindications for
intramuscular injection).

- Trypanophobia.

- Severe nasal or oral diseases, such as acute rhinitis (sinusitis), allergic
rhinitis, oral ulcers, throat redness, and swelling.

- Lung function abnormalities such as chronic obstructive pulmonary disease and
pulmonary fibrosis.

- Abnormal laboratory test indexes that are clinical significant as judged by the
investigator (including white blood cell count, lymphocyte count, eosinophils,
neutrophils, platelets, hemoglobin, alanine aminotransferase ALT, aspartate
aminotransferase AST, total bilirubin , creatinine, activated partial thromboplastin
time) (for sentinel and safety groups only).

- Respiratory rate ≥ 17 times per minute (for sentinel and safety groups only).

- History of receiving immunosuppressant therapy, anti-allergic therapy, cytotoxic
therapy, nebulized corticosteroid therapy in the past 6 months (not including
corticosteroid spray treatment for allergic rhinitis, and surface corticosteroid
treatment for acute non-complicated dermatitis).

- Prior administration of blood products in last 4 months.

- Received other investigational drugs within 1 month before the study.

- Prior administration of live attenuated vaccines within 1 month before the study.

- Prior administration of subunit or inactivated vaccines within 14 days before the
study.

- Current anti-tuberculosis therapy.

- Medical history of Covid-19 disease/infection.

- History of epidemiological exposure to COVID-19; have traveled to medium or
high-risk areas in the past 21 days or have a history of travelling outside the
country

- Any condition that in the opinion of the investigators may interfere with the
participants' compliance or evaluation of study objectives or informed consent (i.e.
medical, psychological, social or other conditions, etc).

Exclusion criteria for second dose:

- Newly emerged situations that meet the first-dose exclusion criteria.

- Vaccine related SAE post first dose vaccination.

- Serious allergic reactions post first dose vaccination.

- Other reasons in the opinion of the investigator.

Eligibility Gender
All
Eligibility Age
Minimum: 6 Years ~ Maximum: 17 Years
Countries
China
Locations

CDC of of Luxi County, Xiangxi Tujia and Miao Autonomous Prefecture, Hunan Province
Xiangxi, Hunan, China

Chen Dong, Study Chair
Seventh Medical Center of PLA General Hospital

Seventh Medical Center of PLA General Hospital
NCT Number
Keywords
Covid-19
Vaccine
Ad5
heterologous
safety
Immunogenicity
6-17 years
Inactivated COVID-19 Vaccine
Boost
MeSH Terms
COVID-19
Vaccines