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

Quadrivalent Influenza Virus Vaccine Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02806804
• Other study ID #: cycdc2016-1
• Status: Enrolling by invitation
• Phase: Phase 3
• First received: June 15, 2016
• Last updated: June 16, 2016
• Start date: May 2016

Study information

• Verified date: June 2016
• Source: Beijing Chaoyang District Centre for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2400
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 60 Years

Eligibility

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:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Quadrivalent Influenza Virus Vaccine

Intervention

Biological:
• one dose test vaccine

• one dose commercially available trivalent influenza vaccine

• One dose of Quadrivalent Influenza Virus Vaccine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Chaoyang District Centre for Disease Control and Prevention

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate serum antibody titers of quadrivalent influenza Vaccine in healthy people.	The serum antibody titers will be evaluated at 28 days after vaccination.	28 days	No
Primary	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.	28 days	Yes