Safety Study of Freeze-dried Live Attenuated Influenza Vaccine for Intranasal Administration in Chinese Adults Aged 3 Years and Older
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Influenza
- Sponsor
- Beijing Chaoyang District Centre for Disease Control and Prevention
- Enrollment
- 80
- Primary Endpoint
- Evaluate the rate of adverse reactions of Live Attenuated Influenza Vaccine for Intranasal Administration
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy subjects more than 3 years
- •Guardian and/or subjects aged at least 10 subjects can be informed consent, and sign a written Informed Consent Form.
- •Subjects, Guardians and his family can obey the demands of the scheme .
- •Axillary temperature less than 37℃
Exclusion Criteria
- •Subjects with flu or infected with flu within 3 months.
- •Subjects have a vaccine allergies, allergic to any kind of composition in experimental vaccine, such as eggs, ovalbumin etc.
- •Subjects have serious side effects to vaccine, such as allergy, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain.
- •Subjects have symptoms of acute infection within a week.
- •Subjects have autoimmune disease or immune function defect, Subjects have used immunosuppressive therapy, cytotoxic treatment or inhaled corticosteroids in the past 6 months.
- •Subjects have congenital malformations, developmental disorder or serious chronic diseases( such as Down's syndrome, diabetes, Sickle cell anemia or nerve system disease)
- •Subjects have asthma unstable that need emergency treatment, hospitalization, intubation, oral or intravenous corticosteroid in the past 2 years.
- •Subjects have medical history or family history of convulsions, seizures, encephalopathy and psychiatric disease.
- •Alienia, functional asplenia, and alienia or splenectomy in any situation.
- •Serious neurological disorders such as Green Barry syndrome.
Outcomes
Primary Outcomes
Evaluate the rate of adverse reactions of Live Attenuated Influenza Vaccine for Intranasal Administration
Time Frame: 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