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

Novartis410 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

410

Conditions

Influenza

Interventions

Adjuvanted and un-adjuvanted influenza vaccinesBIOLOGICAL

16 different formulations of trivalent influenza vaccine and 1 marketed influenza vaccine comparator.

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 35 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

UCL St. Luc - Pharmacy

Brussels, Belgium

Outcomes

Primary Outcomes

Assessment of all adverse events from time of vaccination through study end will be collected to for safety assessment.

Time frame: 50 days

Secondary Outcomes

Strain-specific influenza antibody titers will be used to assess Immunogenicity

Time frame: 50 days

Data from ClinicalTrials.gov

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