search
Back to results

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

Primary Purpose

Influenza

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
evaluated vaccine
imported compared vaccine
domestic compared vaccine
Sponsored by
Beijing Center for Disease Control and Prevention
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza

Eligibility Criteria

6 Months - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Sanhe Centre for Disease Control and Prevention
  • Jiuyuan Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

evaluated vaccine

imported compared vaccine

domestic compared vaccine

Arm Description

0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)

0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)

0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)

Outcomes

Primary Outcome Measures

To evaluate the immunogenicity of evaluated vaccine
The immunologic equivalence of 7days after vaccination of influenza virus vaccine was measured in terms of GMTs.
To evaluate the safety
The incidence of adverse events was analyzed statistically

Secondary Outcome Measures

Full Information

First Posted
July 28, 2012
Last Updated
September 30, 2012
Sponsor
Beijing Center for Disease Control and Prevention
search

1. Study Identification

Unique Protocol Identification Number
NCT01654809
Brief Title
Safety and Immunogenicity Study of Split Influenza Virus Vaccine in Different Age Groups
Official Title
Evaluation of Safety and Immunogenicity Among Different Age-groups Receiving Different Split Influenza Vaccines
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Center for Disease Control and Prevention

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
900 (Actual)

8. Arms, Groups, and Interventions

Arm Title
evaluated vaccine
Arm Type
Experimental
Arm Description
0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)
Arm Title
imported compared vaccine
Arm Type
Active Comparator
Arm Description
0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)
Arm Title
domestic compared vaccine
Arm Type
Active Comparator
Arm Description
0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)
Intervention Type
Biological
Intervention Name(s)
evaluated vaccine
Intervention Description
0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)
Intervention Type
Biological
Intervention Name(s)
imported compared vaccine
Intervention Description
0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)
Intervention Type
Biological
Intervention Name(s)
domestic compared vaccine
Intervention Description
0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)
Primary Outcome Measure Information:
Title
To evaluate the immunogenicity of evaluated vaccine
Description
The immunologic equivalence of 7days after vaccination of influenza virus vaccine was measured in terms of GMTs.
Time Frame
6 months
Title
To evaluate the safety
Description
The incidence of adverse events was analyzed statistically
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nianmin Shi, Master
Organizational Affiliation
Beijing Chaoyang District Center for Disease Control and Prevention
Official's Role
Study Chair
Facility Information:
Facility Name
Sanhe Centre for Disease Control and Prevention
City
Langfang
State/Province
Hebei
Country
China
Facility Name
Jiuyuan Center for Disease Control and Prevention
City
Baotou
State/Province
Inner Mongolia
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs