Safety Study of Quadrivalent Influenza Virus Vaccine in Healthy People Aged 3 Years and Older

NCT02708173 | Completed Phase 1

• 1 other identifier: cycdc2015-5
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the safety of Quadrivalent Influenza Virus Vaccine in Healthy People Aged years 3 to 60.40 Subjects will be equally divided into 2 groups,including 3-17 years old and 18-60 years old.Adult group first receive one dose of Quadrivalent Influenza Virus Vaccine.Then minors group also receive one dose of Quadrivalent Influenza Virus Vaccine after 7 days.

Conditions

Quadrivalent Influenza Virus Vaccine

Keywords

vaccine; safety

Outcome Measures

Primary Outcomes (1)

• The rate of adverse reactions of Quadrivalent Influenza Virus Vaccine

  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 (2)

One dose Vaccine in aged 18-60 years old

EXPERIMENTAL

One dose of Quadrivalent Influenza Virus Vaccine will be given in aged 18-60 years old.

Biological: One dose of Quadrivalent Influenza Virus Vaccine

One dose Vaccine in aged 3-17 years old

EXPERIMENTAL

One dose of Quadrivalent Influenza Virus Vaccine will be given in aged 3-17 years old.

Biological: One dose of Quadrivalent Influenza Virus Vaccine

Interventions

One dose of Quadrivalent Influenza Virus Vaccine BIOLOGICAL

One dose Vaccine in aged 18-60 years old

Eligibility Criteria

• Age: 3 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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℃

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

DongBa clinical center

Beijing, Beijing Municipality, 100021, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2016
• First Posted: March 15, 2016
• Study Start: March 1, 2016
• Primary Completion: March 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 15, 2016

Record last verified: 2016-03

Locations

CN (1)