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Completed

NCT Number: NCT00710866

Influenza Vaccine Dose-Response in Infants and Toddlers: Immunogenicity and Reactogenicity

The purpose of this study is to compare the antibody response and reaction rates in children age 6-23 months when they are given either the currently recommended schedule of two 0.25ml doses of influenza vaccine one month apart or two 0.5ml doses of influenza vaccine, one month apart.

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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–23 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Coquitlam, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Child healthy (stable chronic conditions acceptable) as established by health assessment interview and verbal history-directed health examination
  • Child between and including 6 months of age and 23 months of age (up to and including the day before 24 months of age)
  • Child is available and can complete all relevant procedures during the entire study period
  • Parent or legal guardian is available and can be reached by phone during the entire study period
  • Parent/guardian provides written informed consent
  • Parent/guardian is fluent in English

Exclusion criteria

  • Child has history of laboratory-confirmed influenza
  • Child has history of any prior influenza immunization
  • Child has history of anaphylactic reaction to any component of the vaccine (i.e. egg)
  • Child has received immune globulin or other blood products within the prior six weeks
  • Child has received injected or oral steroids within the prior six weeks (inhaled or topical steroids allowed)
  • Child has a bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection (thrombocytopenia, coagulation disorder, anti-coagulant therapy)
  • Child is or will be enrolled in any other clinical trial of a drug, vaccine or medical device during the study period
  • Child is scheduled to receive a live vaccine (notably measles, mumps, rubella or varicella vaccines) during the study period
  • Child has a health condition which, in the opinion of the investigator, would interfere with the evaluation or pose a health risk to the child

Treatment and study plan

Inactivated Influenza Vaccine Trivalent Types A and B (Split Virion)

Biological

Arm 1 (experimental group) received two spaced injections of the 0.5 mL (full) dose while arm 2 (comparison group) received the currently recommended two spaced injections of 0.25mL (half) dose of trivalent inactivated split virion influenza vaccine (VAXIGRIP®) manufactured by Sanofi Pasteur, Lyon, France.

Other names: VAXIGRIP®

Primary outcomes

  1. Seroprotection Rate Infants (6-11 Months)-A/Brisbane/59/07(H1N1)

    Time frame: 27-46 days after the second dose

    Seroprotection rate: HI titers =>40

  2. Seroprotection Rate Toddlers(12-23 Months)-A/Brisbane/59/07(H1N1)

    Time frame: 27-46 days after the second dose

    Seroprotection rate: HI titers =>40

  3. Seroprotection Rate Infants(6-11 Months)-A/Brisbane/10/07(H3N2)

    Time frame: 27-46 days after the second dose

    Seroprotection rate: HI titers =>40

  4. Seroprotection Rate Toddlers(12-23 Months)-A/Brisbane/10/07(H3N2)

    Time frame: 27-46 days after the second dose

    Seroprotection rate: HI titers =>40

  5. Seroprotection Rate Infants (6-11 Months)-B/Florida/4/06(Yamagata)

    Time frame: 27-46 days after the second dose

  6. Seroprotection Rate Toddlers (12-23 Months)-B/Florida/4/06(Yamagata)

    Time frame: 27-46 days after the second dose

    Seroprotection rate: HI titers =>40

  7. Adverse Events: Fever After Either Dose - Infants 6-11 Months

    Time frame: 3 days after immunization

    Fever defined as temperature >= 38 C

  8. Adverse Events: Fever After Either Dose - Toddlers(12-23 Months)-

    Time frame: 3 days after immunization

    Fever defined as temperature >= 38 C

Sponsors and collaborators

Lead sponsor

British Columbia Centre for Disease Control

Other Gov

Registry information

Acronym: TITRE

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 8, 2008
Registry last updated
Aug 4, 2011

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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