Influenza
Conditions
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.
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.
Interventions
BIOLOGICALevaluated vaccine
0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)
BIOLOGICALimported compared vaccine
0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)
BIOLOGICALdomestic compared vaccine
0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)
Sponsors
Beijing Center for Disease Control and Prevention
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the immunogenicity of evaluated vaccine | 6 months | The immunologic equivalence of 7days after vaccination of influenza virus vaccine was measured in terms of GMTs. |
| To evaluate the safety | 4 months | The incidence of adverse events was analyzed statistically |
Countries
China
Outcome results
None listed