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Status unknownNCT02665871Updated Aug 15, 2016

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

A Phase 1 interventional study of one dose of Influenza Vaccine and one dose of Influenza Vaccine in Influenza, sponsored by Beijing Chaoyang District Centre for Disease Control and Prevention. Status unknown. Open to participants aged 3 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-08-15.

Sponsored by Beijing Chaoyang District Centre for Disease Control and Prevention · Phase 1, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jan 2016), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
3 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Influenza

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Keywords

  • vaccine
  • safety
  • intranasal administration
03

In context

Influenza, Human

2,265 studies on the registry are indexed under Influenza, Human; 173 are open to participants now.

This study's enrollment of 80 is below the median of 240 across 1,894 interventional studies indexed under Influenza, Human.

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Lead sponsor

Beijing Chaoyang District Centre for Disease Control and Prevention is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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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

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.
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
80 participants (actual)

Study arms

  • 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

Interventions

  • Biologicalone dose of Influenza Vaccine
  • Biologicalone dose of Influenza Vaccine
  • Biologicalplacebo
  • Biologicalplacebo
06

What researchers measure

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

    Time frame: 3 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02665871
Lead sponsor
Beijing Chaoyang District Centre for Disease Control and Prevention
Responsible party
Sponsor
First posted
Jan 28, 2016
Start date
Mar 2016
Primary completion
Jun 2016
Completion
Sep 2016 (estimated)
Last update
Aug 15, 2016
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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