A Dose Ranging Study Comparing Different Combinations of Adjuvanted and Non-adjuvanted Influenza Vaccines in Healthy Children 6 to <36 Months of Age

Novartis

Status and phase: Completed; Phase 1

Conditions: Influenza

Treatments: Biological: Adjuvanted and un-adjuvanted influenza vaccines

Study type: Interventional

Funder types: Industry

Identifiers

NCT00848887

V104P2

2008-002602-20

Details and patient eligibility

About

This study will evaluate the safety and immunogenicity of different combinations of influenza vaccine in healthy young children.

Enrollment: 410 patients

Sex: All

Ages: 6 to 35 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Children of 6 month to <36 month of age in good health as determined by medical history, physical assessment and clinical judgement of the investigator.

Exclusion criteria

• History of serious disease. History of serious reaction following administration of vaccine or hypersensitivity to vaccine components. Known or suspected impairment/alteration of immune function.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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410 participants in 1 patient group

1

Experimental group

Treatment:

Biological: Adjuvanted and un-adjuvanted influenza vaccines