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

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.

Study Overview

• Status: Unknown
• Conditions: Influenza
• Intervention / Treatment: Biological: one dose of Influenza Vaccine; Biological: placebo

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: one dose of Influenza Vaccine in aged 18 years and older; One dose of Freeze-dried Live Attenuated Influenza Vaccine for Intranasal Administration in aged 18 years and older	Biological: one dose of Influenza Vaccine
Experimental: One dose of Influenza Vaccine in aged 3-17 year; One dose of Freeze-dried Live Attenuated Influenza Vaccine for Intranasal Administration in aged 3-17 years	Biological: one dose of Influenza Vaccine
Placebo Comparator: placebo in aged 18 years and older; placebo in 10 subjects aged 18 years and older on day 0	Biological: placebo
Placebo Comparator: placebo in aged 3-17 years; placebo in 10 subjects aged 3-17 years on day 0	Biological: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Beijing Chaoyang District Centre for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): June 1, 2016
• Study Completion (Anticipated): September 1, 2016

Study Registration Dates

• First Submitted: January 21, 2016
• First Submitted That Met QC Criteria: January 25, 2016
• First Posted (Estimate): January 28, 2016

Study Record Updates

• Last Update Posted (Estimate): August 15, 2016
• Last Update Submitted That Met QC Criteria: August 12, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: safety; vaccine; intranasal administration
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: cycdc2015-4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No