Safety, and Immunogenicity of Two Influenza Vaccines in Healthy Subjects 3 to 64 Years Old

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1893 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2007-12-31

Brief Summary

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This protocol is designed to evaluate safety, clinical tolerability and immunogenicity of the 2007 southern hemisphere formulation of a Novartis conventional influenza vaccine licensed in the EU and many other worldwide countries, according to the US FDA Draft Guidance for Industry "Clinical data needed to support the licensure of trivalent inactivated influenza vaccine", issued in March 2006, and to evaluate safety, clinical tolerability and immunogenicity of the 2007 southern hemisphere formulation of a Novartis conventional influenza vaccine already licensed in US. The purpose of the control arm is primarily to provide a comparative assessment for safety, not immunogenicity or effectiveness.

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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

DOUBLE

Participants Investigators

Study Groups

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Influenza virus vaccine

Group Type EXPERIMENTAL

Influenza virus vaccine

Intervention Type BIOLOGICAL

Two intramuscular injections of the investigational influenza virus vaccine administered 4 weeks part to group 3 to 8 years of age while one injection was administered to groups 9 to 17 years of age and 18 to 64 years of age.

Comparator influenza vaccine

Group Type ACTIVE_COMPARATOR

Comparator influenza vaccine

Intervention Type BIOLOGICAL

Two intramuscular injections were administered 4 weeks apart to group 3 to 8 years of age while one injection was administered to groups 9 to 17 years of age and 18 to 64 years of age.

Interventions

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Influenza virus vaccine

Two intramuscular injections of the investigational influenza virus vaccine administered 4 weeks part to group 3 to 8 years of age while one injection was administered to groups 9 to 17 years of age and 18 to 64 years of age.

Intervention Type BIOLOGICAL

Comparator influenza vaccine

Two intramuscular injections were administered 4 weeks apart to group 3 to 8 years of age while one injection was administered to groups 9 to 17 years of age and 18 to 64 years of age.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Healthy subjects 3 to 64 years of age

Exclusion Criteria

* Receipt of other investigational products within 3 months or other vacine within 1 month;
* Allergy to eggs, egg products, or any other vaccine component;
* Laboratory confirmed influenza disease within 6 months;
* Have previously received an influenza vaccination (3 to 8 years only);

Minimum Eligible Age

3 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes