Back to resultsSafety Study of Freeze-dried Live Attenuated Influenza Vaccine for Intranasal Administration in Chinese Adults Aged 3 Years and Older
Primary Purpose
Influenza
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
one dose of Influenza Vaccine
one dose of Influenza Vaccine
placebo
placebo
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring vaccine, safety, intranasal administration
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.
- 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.
- The indicators of blood test or urine test do not conform to the inclusion criteria.
- 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.
- Axillary temperature is more than 37℃ before vaccination.
- Subjects are pregnant or plan to become pregnant
- Subjects are participate in other clinical trials.
- Any factors unsuitable for clinical trail at the discretion of the investigator.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Arm Label
one dose of Influenza Vaccine in aged 18 years and older
One dose of Influenza Vaccine in aged 3-17 year
placebo in aged 18 years and older
placebo in aged 3-17 years
Arm Description
One dose of Freeze-dried Live Attenuated Influenza Vaccine for Intranasal Administration in aged 18 years and older
One dose of Freeze-dried Live Attenuated Influenza Vaccine for Intranasal Administration in aged 3-17 years
placebo in 10 subjects aged 18 years and older on day 0
placebo in 10 subjects aged 3-17 years on day 0
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02665871
First Posted
January 21, 2016
Last Updated
August 12, 2016
Sponsor
Beijing Chaoyang District Centre for Disease Control and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT02665871
Brief Title
Safety Study of Freeze-dried Live Attenuated Influenza Vaccine for Intranasal Administration in Chinese Adults Aged 3 Years and Older
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
September 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Chaoyang District Centre for Disease Control and Prevention
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
vaccine, safety, intranasal administration
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
one dose of Influenza Vaccine in aged 18 years and older
Arm Type
Experimental
Arm Description
One dose of Freeze-dried Live Attenuated Influenza Vaccine for Intranasal Administration in aged 18 years and older
Arm Title
One dose of Influenza Vaccine in aged 3-17 year
Arm Type
Experimental
Arm Description
One dose of Freeze-dried Live Attenuated Influenza Vaccine for Intranasal Administration in aged 3-17 years
Arm Title
placebo in aged 18 years and older
Arm Type
Placebo Comparator
Arm Description
placebo in 10 subjects aged 18 years and older on day 0
Arm Title
placebo in aged 3-17 years
Arm Type
Placebo Comparator
Arm Description
placebo in 10 subjects aged 3-17 years on day 0
Intervention Type
Biological
Intervention Name(s)
one dose of Influenza Vaccine
Intervention Type
Biological
Intervention Name(s)
one dose of Influenza Vaccine
Intervention Type
Biological
Intervention Name(s)
placebo
Intervention Type
Biological
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Evaluate the rate of adverse reactions of Live Attenuated Influenza Vaccine for Intranasal Administration
Description
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
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
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.
The indicators of blood test or urine test do not conform to the inclusion criteria.
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.
Axillary temperature is more than 37℃ before vaccination.
Subjects are pregnant or plan to become pregnant
Subjects are participate in other clinical trials.
Any factors unsuitable for clinical trail at the discretion of the investigator.
12. IPD Sharing Statement
Learn more about this trial
Safety Study of Freeze-dried Live Attenuated Influenza Vaccine for Intranasal Administration in Chinese Adults Aged 3 Years and Older
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