Safety of Two Trivalent Influenza Vaccines Evaluated in Children and Adolescents 4 to 17 Years of Age

Novartis

Status and phase: Completed; Phase 3

Conditions: Fever; Influenza

Treatments: Biological: Egg based flu vaccine; Biological: Mammalian cell based flu vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01857206

U1111-1139-9440 (Other Identifier)

V58_31

Details and patient eligibility

About

Evaluate safety and tolerability of TIVa or TIVb vaccine in healthy children and adolescents 4 to 17 years of age.

Enrollment: 2,055 patients

Sex: All

Ages: 4 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy subjects 4-17 years of age

Exclusion criteria

• Subjects who are not healthy,
• Subjects who are pregnant or breast feeding,
• Subjects with a history of severe allergic reaction or allergic to any of the vaccine components.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,055 participants in 2 patient groups

TIVc

Experimental group

Description:

Subjects ≥4 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.

Treatment:

Biological: Mammalian cell based flu vaccine

TIVf

Active Comparator group

Description:

Subjects ≥4 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.

Treatment:

Biological: Egg based flu vaccine