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Status unknownNCT02806804Updated Jun 21, 2016

Safety and Immunogenicity Study of Quadrivalent Influenza Virus Vaccine in Healthy People Aged Years 3-60

A Phase 3 interventional study of one dose test vaccine and one dose commercially available trivalent influenza vaccine in Quadrivalent Influenza Virus Vaccine, sponsored by Beijing Chaoyang District Centre for Disease Control and Prevention. Status unknown. Open to participants aged 3 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-06-21.

Sponsored by Beijing Chaoyang District Centre for Disease Control and Prevention · Phase 3, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jun 2016), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
2,400
Allocation
Randomized
Ages
3 Years to 60 Years
Sex
All
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Study summary

This study evaluates the safety and immunogenicity of the quadrivalent influenza virus vaccine in healthy people aged years 3-60.Subjects will be randomly divided into 3 groups,receiving the test vaccine, commercially available trivalent influenza vaccine and trivalent influenza vaccine containing new influenza B component respectively. Each group has 800 subjects,2400 in total.

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Conditions studied

  • Quadrivalent Influenza Virus Vaccine

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Keywords

  • vaccine
  • safety
  • immunogenicity
03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's planned enrollment of 2,400 is above the median of 238 across 1,853 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 11 studies on the registry; none are open to participants now.

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

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Who can participate

Ages eligible
3 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • healthy subjects more than 3 years old, and the subjects can be informed consent, and sign the informed consent.
  • the subjects and his guardians can obey the demands of the scheme .
  • Axillary temperature less than 37℃

Exclusion criteria

Exclusion Criteria:

  • The people who has flu or influenza-like symptoms(fever \<axillary temperature ≥38 ℃>, cough or sore throat) within 3 months
  • The people who has vaccinated influenza vaccine in 3years.
  • The people who has a vaccine allergies, or who allergic to any kind of composition in experimental vaccine, such as eggs, ovalbumin etc.
  • The people who has serious side effects to vaccine, such as allergy, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain.
  • the subject who has symptoms of acute infection within a week.
  • Autoimmune diseases or Immune function defect, people has immunosuppressive therapy, cytotoxic treatment or inhaled corticosteroids in the past 6 months.
  • People has congenital malformations, developmental disorder or serious chronic diseases( such as Down's syndrome, diabetes, Sickle cell anemia or nerve system disease)
  • People has asthma Unstable that need emergency treatment, hospitalization, intubation, oral or intravenous corticosteroid in the past 2 years.
  • Diagnosed abnormal coagulation(Lack of clotting factors,Clotting disorders,Platelet abnormality) or significant bruising or coagulopathy
  • people has history or family history of convulsions, seizures, encephalopathy and psychiatric.
  • alienia, functional asplenia, and alienia or splenectomy in any situation.
  • Serious neurological disorders such as Green Barry syndrome.
  • people who has received blood products or immunoglobulin products in the past one months.
  • people who has received other study drug in the past one month.
  • people who received live attenuated vaccine, subunit vaccine or inactivated vaccine.
  • people who has received allergy treatment in in the past 14 days.
  • People who is on anti-TB treatment.
  • People whose axillary temperature is more than 37℃ before the vaccination.
  • People who is pregnant.
  • Any factors unsuitable for clinical trail according to the researchers.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
2,400 participants (estimated)

Study arms

  • Experimental
    one dose test vaccine

    One dose of quadrivalent influenza virus vaccine will be randomly given in aged 3-60 years old.

    Biological: one dose test vaccine

  • Experimental
    one dose commercially available trivalent influenza vaccine

    One dose of trivalent influenza virus vaccine will be randomly given in aged 3-60 years old.

    Biological: one dose commercially available trivalent influenza vaccine

  • Experimental
    One dose quadrivalent influenza virus vaccine

    One dose of quadrivalent influenza virus vaccine (trivalent influenza virus vaccine added to a new influenza B component) will be randomly given in aged 3-60 years old.

    Biological: One dose of Quadrivalent Influenza Virus Vaccine

Interventions

  • Biologicalone dose test vaccine
  • Biologicalone dose commercially available trivalent influenza vaccine
  • BiologicalOne dose of Quadrivalent Influenza Virus Vaccine
06

What researchers measure

Primary outcomes

  1. Evaluate serum antibody titers of quadrivalent influenza Vaccine in healthy people.

    The serum antibody titers will be evaluated at 28 days after vaccination.

    Time frame: 28 days

  2. Evaluate the Rate of Adverse reactions of quadrivalent influenza Vaccine in healthy people.

    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: 28 days

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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 Jun 21, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02806804
Lead sponsor
Beijing Chaoyang District Centre for Disease Control and Prevention
Responsible party
Sponsor
First posted
Jun 21, 2016
Start date
May 2016
Primary completion
Jun 2016
Last update
Jun 21, 2016
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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

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