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

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01654809
• Other study ID #: BJCDPC-1
• Status: Completed
• Phase: Phase 4
• First received: July 28, 2012
• Last updated: September 30, 2012
• Start date: August 2010
• Est. completion date: June 2011

Study information

• Verified date: July 2012
• Source: Beijing Center for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 900
• Est. completion date: June 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• evaluated vaccine
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)
• domestic compared vaccine
0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)

Locations

Country	Name	City	State
China	Jiuyuan Center for Disease Control and Prevention	Baotou	Inner Mongolia
China	Sanhe Centre for Disease Control and Prevention	Langfang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Center for Disease Control and Prevention

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	To evaluate the safety	The incidence of adverse events was analyzed statistically	4 months	Yes