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

NCT ID: NCT01654809

Last Updated: 2012-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-06-30

Brief Summary

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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

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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.

Conditions

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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evaluated vaccine

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

Group Type EXPERIMENTAL

evaluated vaccine

Intervention Type BIOLOGICAL

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

imported compared vaccine

Intervention Type BIOLOGICAL

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

domestic compared vaccine

Intervention Type BIOLOGICAL

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

imported compared vaccine

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

Group Type ACTIVE_COMPARATOR

evaluated vaccine

Intervention Type BIOLOGICAL

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

imported compared vaccine

Intervention Type BIOLOGICAL

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

domestic compared vaccine

Intervention Type BIOLOGICAL

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

domestic compared vaccine

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

Group Type ACTIVE_COMPARATOR

evaluated vaccine

Intervention Type BIOLOGICAL

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

imported compared vaccine

Intervention Type BIOLOGICAL

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

domestic compared vaccine

Intervention Type BIOLOGICAL

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

Interventions

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evaluated vaccine

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

Intervention Type BIOLOGICAL

imported compared vaccine

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

Intervention Type BIOLOGICAL

domestic compared vaccine

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beijing Center for Disease Control and Prevention

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nianmin Shi, Master

Role: STUDY_CHAIR

Beijing Chaoyang District Center for Disease Control and Prevention

Locations

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Sanhe Centre for Disease Control and Prevention

Langfang, Hebei, China

Site Status

Jiuyuan Center for Disease Control and Prevention

Baotou, Inner Mongolia, China

Site Status

Countries

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China

Other Identifiers

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BJCDPC-1

Identifier Type: -

Identifier Source: org_study_id