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OpenTrials
Completed

NCT Number: NCT00735020

Study to Evaluate Safety, Tolerability and Immunogenicity of a Bedside Mixing Combination of Two Adjuvanted Influenza Vaccines

This trial is designed to evaluate safety, tolerability and immunogenicity of a bedside mixing formulation of adjuvanted influenza vaccines.

Completed

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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

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

I.P.A.S.

Ligornetto, 36 6853, Switzerland

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy 18 to 39 year old males and females who are in good health and have provided informed consent prior to enrollment

Exclusion criteria

  • serious medical conditions
  • allergies to vaccine components, including but not limited to egg/chicken products
  • reduced immune function
  • recent use of immunosuppressive therapy
  • recent use of influenza vaccine

Treatment and study plan

Adjuvanted Influenza Vaccine

Biological

1 dose of Adjuvanted Influenza Vaccine

influenza vaccine

Biological

1 dose of Influenza Vaccine

Primary outcomes

  1. Safety as measured through local and systemic reactions and efficacy (immunogenicity) as measured by antibody titers.

    Time frame: 36 Days

Secondary outcomes

  1. To evaluate immunogenicity of a single IM injection of adjuvanted Influenza vaccine

    Time frame: 36 Days

Sponsors and collaborators

Lead sponsor

Novartis Vaccines

Industry

Registry information

Official study title

A Phase I, Observer-Blind, Randomized, Single-Center Study to Evaluate Safety, Tolerability and Immunogenicity of a Bedside Mixing Combination of Two Adjuvanted Influenza Vaccines in Healthy Adults Aged 18 to 39 Years.

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Aug 14, 2008
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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