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

Evaluation of Safety and Immunogenicity Among Different Age-groups Receiving Different Split Influenza Vaccines

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.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: evaluated vaccine; Biological: imported compared vaccine; Biological: domestic compared vaccine

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.

• Study Type: Interventional
• Enrollment (Actual): 900
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Hebei
    • Langfang, Hebei, China
      • Sanhe Centre for Disease Control and Prevention
  • Inner Mongolia
    • Baotou, Inner Mongolia, China
      • Jiuyuan Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: evaluated vaccine; 0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)	Biological: evaluated vaccine; 0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose); Biological: imported compared vaccine; 0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose); Biological: domestic compared vaccine; 0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)
Active Comparator: imported compared vaccine; 0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)	Biological: evaluated vaccine; 0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose); Biological: imported compared vaccine; 0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose); Biological: domestic compared vaccine; 0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)
Active Comparator: domestic compared vaccine; 0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)	Biological: evaluated vaccine; 0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose); Biological: imported compared vaccine; 0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose); Biological: domestic compared vaccine; 0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Beijing Center for Disease Control and Prevention
• Investigators: Study Chair: Nianmin Shi, Master, Beijing chaoyang district center for disease control and prevention

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: July 28, 2012
• First Submitted That Met QC Criteria: July 31, 2012
• First Posted (Estimate): August 1, 2012

Study Record Updates

• Last Update Posted (Estimate): October 2, 2012
• Last Update Submitted That Met QC Criteria: September 30, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: BJCDPC-1