Safety Study of Freeze-dried Live Attenuated Influenza Vaccine for Intranasal Administration in Chinese Adults Aged 3 Years and Older

Beijing Chaoyang District Centre for Disease Control and Prevention

Status and phase: Unknown; Phase 1

Conditions: Influenza

Treatments: Biological: placebo; Biological: one dose of Influenza Vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT02665871

cycdc2015-4

Details and patient eligibility

About

This study evaluates the safety of freeze-dried live attenuated influenza vaccine for intranasal administration in chinese adults aged 3 years and older.80 subjects will be divided into 2 groups, including 18 years and older and 3-17 years old. Subjects in each groups will randomly receive one dose of influenza vaccine or placebo in a 3:1 ratio.

Enrollment: 80 patients

Sex: All

Ages: 3+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy subjects more than 3 years
2. Guardian and/or subjects aged at least 10 subjects can be informed consent, and sign a written Informed Consent Form.
3. Subjects, Guardians and his family can obey the demands of the scheme .
4. Axillary temperature less than 37℃

Exclusion criteria

1. Subjects with flu or infected with flu within 3 months.
2. Subjects have a vaccine allergies, allergic to any kind of composition in experimental vaccine, such as eggs, ovalbumin etc.
3. Subjects have serious side effects to vaccine, such as allergy, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain.
4. Subjects have symptoms of acute infection within a week.
5. Subjects have autoimmune disease or immune function defect, Subjects have used immunosuppressive therapy, cytotoxic treatment or inhaled corticosteroids in the past 6 months.
6. Subjects have congenital malformations, developmental disorder or serious chronic diseases( such as Down's syndrome, diabetes, Sickle cell anemia or nerve system disease)
7. Subjects have asthma unstable that need emergency treatment, hospitalization, intubation, oral or intravenous corticosteroid in the past 2 years.
8. Subjects have medical history or family history of convulsions, seizures, encephalopathy and psychiatric disease.
9. Alienia, functional asplenia, and alienia or splenectomy in any situation.
10. Serious neurological disorders such as Green Barry syndrome.
11. Subjects have received blood products or immunoglobulin products within 3 months before experimental vaccine inoculated.
12. Subjects have received other study drug in the past month or received live vaccine, subunit vaccine or inactivated vaccine.
13. The indicators of blood test or urine test do not conform to the inclusion criteria.
14. Subjects have received allergy treatment in in the past 14 days.
15. Subjects are receiving anti-tuberculosis treatment.
16. Subjects have inoculated flu vaccine in the flu reason.
17. Axillary temperature is more than 37℃ before vaccination.
18. Subjects are pregnant or plan to become pregnant
19. Subjects are participate in other clinical trials.
20. Any factors unsuitable for clinical trail at the discretion of the investigator.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 4 patient groups, including a placebo group

one dose of Influenza Vaccine in aged 18 years and older

Experimental group

Description:

One dose of Freeze-dried Live Attenuated Influenza Vaccine for Intranasal Administration in aged 18 years and older

Treatment:

Biological: one dose of Influenza Vaccine

Biological: one dose of Influenza Vaccine

One dose of Influenza Vaccine in aged 3-17 year

Experimental group

Description:

One dose of Freeze-dried Live Attenuated Influenza Vaccine for Intranasal Administration in aged 3-17 years

Treatment:

Biological: one dose of Influenza Vaccine

Biological: one dose of Influenza Vaccine

placebo in aged 18 years and older

Placebo Comparator group

Description:

placebo in 10 subjects aged 18 years and older on day 0

Treatment:

Biological: placebo

Biological: placebo

placebo in aged 3-17 years

Placebo Comparator group

Description:

placebo in 10 subjects aged 3-17 years on day 0

Treatment:

Biological: placebo

Biological: placebo