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

NCT02665871 | Unknown Phase 1

• 1 other identifier: cycdc2015-4
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Influenza

Keywords

vaccine; safety; intranasal administration

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

one dose of Influenza Vaccine in aged 18 years and older

EXPERIMENTAL

One dose of Freeze-dried Live Attenuated Influenza Vaccine for Intranasal Administration in aged 18 years and older

Biological: one dose of Influenza Vaccine

One dose of Influenza Vaccine in aged 3-17 year

EXPERIMENTAL

One dose of Freeze-dried Live Attenuated Influenza Vaccine for Intranasal Administration in aged 3-17 years

Biological: one dose of Influenza Vaccine

placebo in aged 18 years and older

PLACEBO COMPARATOR

placebo in 10 subjects aged 18 years and older on day 0

Biological: placebo

placebo in aged 3-17 years

PLACEBO COMPARATOR

placebo in 10 subjects aged 3-17 years on day 0

Biological: placebo

Interventions

one dose of Influenza Vaccine BIOLOGICAL

one dose of Influenza Vaccine in aged 18 years and older

placebo BIOLOGICAL

placebo in aged 18 years and older

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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℃

You may not qualify if:

• 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.
• Subjects have received blood products or immunoglobulin products within 3 months before experimental vaccine inoculated.
• Subjects have received other study drug in the past month or received live vaccine, subunit vaccine or inactivated vaccine.
• Subjects have received allergy treatment in in the past 14 days.
• Subjects are receiving anti-tuberculosis treatment.
• Subjects have inoculated flu vaccine in the flu reason.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2016
• First Posted: January 28, 2016
• Study Start: March 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: September 1, 2016
• Last Updated: August 15, 2016

Record last verified: 2016-01