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

Influenza Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02665871
• Other study ID #: cycdc2015-4
• Status: Enrolling by invitation
• Phase: Phase 1
• First received: January 21, 2016
• Last updated: August 12, 2016
• Start date: March 2016
• Est. completion date: September 2016

Study information

• Verified date: January 2016
• Source: Beijing Chaoyang District Centre for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: September 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• one dose of Influenza Vaccine

• one dose of Influenza Vaccine

• placebo

• placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Chaoyang District Centre for Disease Control and Prevention

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the rate of adverse reactions of Live Attenuated Influenza Vaccine for Intranasal Administration	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	3 months	Yes