NCT01654809

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 1, 2012

Completed
Last Updated

October 2, 2012

Status Verified

July 1, 2012

Enrollment Period

6 months

First QC Date

July 28, 2012

Last Update Submit

September 30, 2012

Conditions

Influenza

Outcome Measures

Primary Outcomes (2)

  • To evaluate the immunogenicity of evaluated vaccine

    The immunologic equivalence of 7days after vaccination of influenza virus vaccine was measured in terms of GMTs.

    6 months

  • To evaluate the safety

    The incidence of adverse events was analyzed statistically

    4 months

Study Arms (3)

evaluated vaccine

EXPERIMENTAL

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

Biological: evaluated vaccineBiological: imported compared vaccineBiological: domestic compared vaccine

imported compared vaccine

ACTIVE COMPARATOR

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

Biological: evaluated vaccineBiological: imported compared vaccineBiological: domestic compared vaccine

domestic compared vaccine

ACTIVE COMPARATOR

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

Biological: evaluated vaccineBiological: imported compared vaccineBiological: domestic compared vaccine

Interventions

evaluated vaccineBIOLOGICAL

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

domestic compared vaccineevaluated vaccineimported compared vaccine
imported compared vaccineBIOLOGICAL

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

domestic compared vaccineevaluated vaccineimported compared vaccine
domestic compared vaccineBIOLOGICAL

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

domestic compared vaccineevaluated vaccineimported compared vaccine

Eligibility Criteria

Age6 Months+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sanhe Centre for Disease Control and Prevention

Langfang, Hebei, China

Location

Jiuyuan Center for Disease Control and Prevention

Baotou, Inner Mongolia, China

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Nianmin Shi, Master

    Beijing Chaoyang District Center for Disease Control and Prevention

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2012

First Posted

August 1, 2012

Study Start

August 1, 2010

Primary Completion

February 1, 2011

Study Completion

June 1, 2011

Last Updated

October 2, 2012

Record last verified: 2012-07

Locations

CN(2)