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Completed

NCT Number: NCT01654809

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

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.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

6 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanhe Centre for Disease Control and Prevention, Langfang, Hebei, China

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

evaluated vaccine

Biological

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

imported compared vaccine

Biological

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

domestic compared vaccine

Biological

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

Primary outcomes

  1. To evaluate the immunogenicity of evaluated vaccine

    Time frame: 6 months

    The immunologic equivalence of 7days after vaccination of influenza virus vaccine was measured in terms of GMTs.

  2. To evaluate the safety

    Time frame: 4 months

    The incidence of adverse events was analyzed statistically

Sponsors and collaborators

Lead sponsor

Beijing Center for Disease Control and Prevention

Other Gov

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 1, 2012
Registry last updated
Oct 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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