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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

262 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-03-31

Brief Summary

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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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Detailed Description

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Conditions

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

2 doses 0.5mL VAXIGRIP® at months 0, 1

Group Type EXPERIMENTAL

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

Intervention Type 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.

2

2 doses 0.25mL VAXIGRIP® at months 0, 1

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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.

Interventions

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

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.

Intervention Type BIOLOGICAL

Other Intervention Names

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VAXIGRIP®

Eligibility Criteria

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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

Minimum Eligible Age

6 Months

Maximum Eligible Age

23 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes