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OpenTrials
Completed

NCT Number: NCT00848887

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

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

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

6 month–35 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

UCL St. Luc - Pharmacy

Brussels, 1200, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adjuvanted and un-adjuvanted influenza vaccines

Biological

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

Primary outcomes

  1. 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

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

    Time frame: 50 days

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Collaborators

  • Novartis Vaccines

Registry information

Official study title

A Phase Ib, Randomized, Observer-Blind, Multicenter, Factorial-Design Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Injections of Trivalent Inactivated Influenza Vaccine With or Without a Second Influenza B Strain in Combination With or Without One of Three Different Doses of Adjuvant in Healthy Children, Aged 6 to <36 Months

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 20, 2009
Registry last updated
Jan 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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