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Safety and Immunogenicity Study of Aleph Inactivated Split Influenza Vaccine

Primary Purpose

Healthy

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
recombinant hepatitis b vaccine
Aleph influenza 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 Healthy focused on measuring Inactivated split influenza vaccine, Immunogenicity, Safety, Consistence

Eligibility Criteria

3 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • more than three years in good healthy

Exclusion Criteria:

  • current infectious fever or acute disease
  • upper respiratory infectious symptom within 6m
  • a history of allergy
  • laboratory confirmed influenza
  • autoimmune disease
  • have get influenza vaccine since 2008

Sites / Locations

  • Xinglong County Center for Disease Control and Prevention
  • Zhuolu County Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

recombinant hepatitis b vaccine

Aleph influenza vaccine

Arm Description

0.5ml intramuscular

0.5ml intramuscular

Outcomes

Primary Outcome Measures

Incidence rate of adverse events of the inactivated split influenza vaccine

Secondary Outcome Measures

Antibody titre of the inactivated split influenza vaccine

Full Information

First Posted
December 20, 2012
Last Updated
March 27, 2013
Sponsor
Beijing Center for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT01758185
Brief Title
Safety and Immunogenicity Study of Aleph Inactivated Split Influenza Vaccine
Official Title
Phase 4 Safety and Immunogenicity Study of Aleph Inactivated Split Influenza Vaccine
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
December 2012 (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 objective of this study was to evaluate the safety and immunogenicity of one inactivated split influenza vaccine, a primarily Chinese-marketed trivalent vaccine.
Detailed Description
A total of 3308 subjects were stratified equally into four age groups and receive either influenza vaccine or recombinant hepatitis b vaccine (seen as placebo). Systematic and local adverse reactions were reported for 28 d after the vaccination. Antibody levels were detected through hemagglutination inhibition assay before vaccination (Baseline) and 28d after the vaccination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
Inactivated split influenza vaccine, Immunogenicity, Safety, Consistence

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
3308 (Actual)

8. Arms, Groups, and Interventions

Arm Title
recombinant hepatitis b vaccine
Arm Type
Placebo Comparator
Arm Description
0.5ml intramuscular
Arm Title
Aleph influenza vaccine
Arm Type
Experimental
Arm Description
0.5ml intramuscular
Intervention Type
Biological
Intervention Name(s)
recombinant hepatitis b vaccine
Intervention Description
0.5ml intramuscular
Intervention Type
Biological
Intervention Name(s)
Aleph influenza vaccine
Intervention Description
0.5ml intramuscular
Primary Outcome Measure Information:
Title
Incidence rate of adverse events of the inactivated split influenza vaccine
Time Frame
two years
Secondary Outcome Measure Information:
Title
Antibody titre of the inactivated split influenza vaccine
Time Frame
two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: more than three years in good healthy Exclusion Criteria: current infectious fever or acute disease upper respiratory infectious symptom within 6m a history of allergy laboratory confirmed influenza autoimmune disease have get influenza vaccine since 2008
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
Principal Investigator
Facility Information:
Facility Name
Xinglong County Center for Disease Control and Prevention
City
Zhangjiakou
State/Province
Hebei
Country
China
Facility Name
Zhuolu County Center for Disease Control and Prevention
City
Zhangjiakou
State/Province
Hebei
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
26083828
Citation
Bai Y, Shi N, Lu Q, Yang L, Wang Z, Li L, Han H, Zheng D, Luo F, Zhang Z, Ai X. Immunological persistence of a seasonal influenza vaccine in people more than 3 years old. Hum Vaccin Immunother. 2015;11(7):1648-53. doi: 10.1080/21645515.2015.1037998.
Results Reference
derived
PubMed Identifier
24301228
Citation
Li S, Li L, Ai X, Yang L, Bai Y, Wang Z, Han H, Lu Q, Luo F, Zhang Z, Liu C, Xiao J, Shi N. A randomized, controlled, blinded study of the safety, immunogenicity and batch consistency of Aleph inactivated split influenza vaccine made in China in Chinese people. Hum Vaccin Immunother. 2014;10(3):557-65. doi: 10.4161/hv.27329. Epub 2013 Dec 3.
Results Reference
derived

Learn more about this trial

Safety and Immunogenicity Study of Aleph Inactivated Split Influenza Vaccine

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