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

Beijing Center for Disease Prevention and Control

Status and phase: Completed; Phase 4

Conditions: Influenza

Treatments: Biological: imported compared vaccine; Biological: domestic compared vaccine; Biological: evaluated vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT01654809

BJCDPC-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 900 patients

Sex: All

Ages: 6+ months old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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900 participants in 3 patient groups

evaluated vaccine

Experimental group

Description:

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

Treatment:

Biological: domestic compared vaccine

Biological: evaluated vaccine

Biological: imported compared vaccine

imported compared vaccine

Active Comparator group

Description:

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

Treatment:

Biological: domestic compared vaccine

Biological: evaluated vaccine

Biological: imported compared vaccine

domestic compared vaccine

Active Comparator group

Description:

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

Treatment:

Biological: domestic compared vaccine

Biological: evaluated vaccine

Biological: imported compared vaccine