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

B

Beijing Chaoyang District Centre for Disease Control and Prevention

Status and phase

Unknown
Phase 1

Conditions

Influenza

Treatments

Biological: one dose of Influenza Vaccine
Biological: placebo

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

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
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
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
placebo in aged 3-17 years
Placebo Comparator group
Description:
placebo in 10 subjects aged 3-17 years on day 0
Treatment:
Biological: placebo

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems