The Immunogenicity and Safety of 2012-2013 Trivalent Seasonal Influenza Vaccine

NCT01736709 | Completed Phase 4 DMC

• 1 other identifier: PRO-INF-4012
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the immunogenicity and safety of 2012-2013 trivalent seasonal influenza vaccine in 60 healthy infants aged 6-35 months old, 60 healthy adults aged 18-60 years old, and 60 healthy older people aged \> 60 years.

Conditions

Influenza

Keywords

2012-2013 trivalent seasonal influenza vaccine; immunogenicity,; safety

Outcome Measures

Primary Outcomes (1)

• Hemagglutination inhibition (HI) antibody titer of 2012-2013 trivalent seasonal influenza vaccine

  to evaluate the immunogenicity of the vaccine in adults and old people.

  21 days after vaccination

Secondary Outcomes (1)

• Frequency of systemic and local adverse reactions after vaccination

  0-21 days after vaccination

Study Arms (1)

trivalent seasonal influenza vaccine

EXPERIMENTAL

2012-2013 trivalent seasonal influenza vaccine in 60 infants with two-dose regimen, 21 days interval trivalent seasonal influenza vaccine in 60 adults and 60 old people with single-dose regimen

Biological: 2012-2013 trivalent seasonal influenza vaccine

Interventions

2012-2013 trivalent seasonal influenza vaccine BIOLOGICAL

trivalent seasonal influenza vaccine with 0.25 ml ⁄ vial, for infants trivalent seasonal influenza vaccine with 0.5 ml ⁄ vial, for adults and old people

trivalent seasonal influenza vaccine

Eligibility Criteria

• Age: 6 Months - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults aged 18-60 years old, and healthy old people aged \>60 years
• Be able to show legal identity card for the sake of recruitment Without vaccination history of seasonal split influenza vaccine in the recent 3 years
• Not participate in any other clinical trials during the study
• Not receive any immunosuppressive agents during and one month prior to the study
• Be able to understand and sign the informed consent.

You may not qualify if:

• Woman： Who breast-feeding or planning to become pregnant during the study
• Any history of allergic reactions; was allergic to any component of the vaccine, such as eggs or ovalbumin
• Any history of severe adverse reactions to vaccines, such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
• Autoimmune disease or immunodeficiency
• Acute episode of chronic diseases or conditions, including chronic hepatitis, hypertension, diabetes mellitus and cardiovascular diseases
• Guillain-Barre Syndrome
• Women subjects with positive urinary pregnancy test
• Any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis)
• Axillary temperature \>37.0 centigrade at the time of dosing
• Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder requiring therapy that has not been well controlled on medication for the past two years; disorder requiring lithium; or suicidal ideation occurring within five years prior to enrollment
• Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent.
• For infants:
• Healthy male or female aged between 6 and 35 months
• Full-term birth, birth weight 2,500 grams or more
• provided birth certification or vaccination card Parent(s) or legal guardian(s) are able to understand and sign the informed consent

Sponsors & Collaborators

• Sinovac Biotech Co., Ltd: lead

Study Sites (1)

Henan Center for Diseases Control and Prevention

Zhengzhou, Henan, China

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Wan-Shen Guo, BS

  Henan Center for Diseases Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2012
• First Posted: November 29, 2012
• Study Start: November 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 29, 2013

Record last verified: 2012-11

Locations

CN (1)