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

Phase 1

• Conditions: Influenza
• Interventions: Biological: one dose of Influenza Vaccine; Biological: placebo

• Registration Number: NCT02665871
• Lead Sponsor: Beijing Chaoyang District Centre for Disease Control and Prevention

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-01
• Study First Submitted: 2016-01-21
• Study First Submitted QC: 2016-01-25
• Study First Posted: 2016-01-28
• Study Start: 2016-03
• Primary Completion: 2016-06
• Last Update Submitted: 2016-08-12
• Last Update Posted: 2016-08-15
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
One dose of Influenza Vaccine in aged 3-17 year	one dose of Influenza Vaccine	One dose of Freeze-dried Live Attenuated Influenza Vaccine for Intranasal Administration in aged 3-17 years
placebo in aged 3-17 years	placebo	placebo in 10 subjects aged 3-17 years on day 0
one dose of Influenza Vaccine in aged 18 years and older	one dose of Influenza Vaccine	One dose of Freeze-dried Live Attenuated Influenza Vaccine for Intranasal Administration in aged 18 years and older
placebo in aged 18 years and older	placebo	placebo in 10 subjects aged 18 years and older on day 0

Primary Outcome Measures

Name	Time	Method
Evaluate the rate of adverse reactions of Live Attenuated Influenza Vaccine for Intranasal Administration	3 months	Adverse reactions associated with vaccine will be observed in subjects after vaccination. Solicited local adverse events include Pain, Redness, Swelling, Induration, Rash, Pruritus at injection site. solicited general adverse events include Fever, Nausea, Vomiting, Diarrhea, Decreased appetite, Be agitated (irritability, abnormal crying), fatigue, allergy