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Safety and Immunogenicity Study of Split Influenza Virus Vaccine in Different Age Groups

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Beijing Center for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT01654809
First received: July 28, 2012
Last updated: September 30, 2012
Last verified: July 2012
History of Changes
  Purpose

The purpose of this study is to observe the adverse reaction ratio and hemagglutination inhibition (HI) antibody positive rate, Geometric mean titer (GMT) of three brands split influenza virus vaccine in different population.


Condition Intervention Phase
Influenza
 Biological: evaluated vaccine
Biological: imported compared vaccine
Biological: domestic compared vaccine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Evaluation of Safety and Immunogenicity Among Different Age-groups Receiving Different Split Influenza Vaccines

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by Beijing Center for Disease Control and Prevention:

Primary Outcome Measures:
  • To evaluate the immunogenicity of evaluated vaccine [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The immunologic equivalence of 7days after vaccination of influenza virus vaccine was measured in terms of GMTs.

  • To evaluate the safety [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
    The incidence of adverse events was analyzed statistically


Enrollment: 900
Study Start Date: August 2010
Study Completion Date: June 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: evaluated vaccine
0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)
 Biological: evaluated vaccine
0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)
Biological: imported compared vaccine
0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)
Biological: domestic compared vaccine
0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)
Active Comparator: imported compared vaccine
0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)
 Biological: evaluated vaccine
0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)
Biological: imported compared vaccine
0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)
Biological: domestic compared vaccine
0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)
Active Comparator: domestic compared vaccine
0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)
 Biological: evaluated vaccine
0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)
Biological: imported compared vaccine
0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)
Biological: domestic compared vaccine
0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)

Detailed Description:

Observational Objectives:

To describe the safety of evaluated vaccine, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to ≤ 36 months,6th to 12th birthday and ≥ 60th birthday.

To describe the immunogenicity of evaluated vaccine, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to ≤ 36 months, 6th to 12th birthday and ≥ 60rd birthday.

  Eligibility

Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • participants were enrolled (toddlers: 6 months to 3 years; school-aged children: 6 to 12 years and older adults: ≥60 years）
  • Eligible participants were generally healthy or had stable chronic medical conditions (for older adults only)

Exclusion Criteria:

  • History of allergic reaction to any component of the study vaccines or previous influenza vaccine
  • History of systemic hypersensitivity to hens' eggs
  • History of Guillain Barré syndrome following administration of any influenza vaccine
  • Any immunodeficient or immunocompromised conditions
  • Receipt of cytotoxic or immunosuppressive drugs within the past 6 months
  • Receipt of blood-derived product within the past 3 months
  • Receipt of any vaccine within one month prior to study entry with exception of paediatric routine vaccination
  • Receipt of non-study 2010-2011 seasonal TIV
  • Participation in any other study with a non-approved drug during the study
  • Acute febrile disease and other self-limiting illness were the temporary exclusion criteria
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01654809

Locations
China, Hebei
Sanhe Centre for Disease Control and Prevention
Langfang, Hebei, China
China, Inner Mongolia
Jiuyuan Center for Disease Control and Prevention
Baotou, Inner Mongolia, China
Sponsors and Collaborators
Beijing Center for Disease Control and Prevention
Investigators
Study Chair: Nianmin Shi, Master Beijing Chaoyang District Center for Disease Control and Prevention
  More Information

No publications provided

Responsible Party: Beijing Center for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT01654809     History of Changes
Other Study ID Numbers: BJCDPC-1
Study First Received: July 28, 2012
Last Updated: September 30, 2012
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013