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OpenTrials
Completed

NCT Number: NCT00518453

Immunogenicity of a Surface Antigen, Inactivated Influenza Vaccine Formulation 2007-2008

Due to antigenic changes of influenza viruses, the virus strains used in influenza vaccines are adjusted every year according to WHO and CPMP recommendations. Immunogenicity and tolerability of the newly composed vaccines are subject for evaluation in a yearly clinical trial in non-elderly adults and elderly subjects (CPMP/BWP/214/96).

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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–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Health Centre

Suffolk, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy Subjects eligible for enrollment into this study are male and female adult volunteers

Exclusion criteria

  • Any serious disease

Treatment and study plan

Surface antigen inactivated influenza vaccine

Biological

1 dose of Fluvirin 2007/2008 Northern Hemisphere vaccine composition

Primary outcomes

  1. evaluate the antibody response to each influenza vaccine antigen

    Time frame: 21 days post-immunization

Secondary outcomes

  1. Safety and tolerability of the study vaccine in the study population

    Time frame: Throughout the study

Sponsors and collaborators

Lead sponsor

Novartis Vaccines

Industry

Registry information

Official study title

A Phase II, Open-Label, Uncontrolled, Single Center Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated Influenza Vaccine Ph.Eur, Formulation 2007-2008, When Administered to Non-Elderly Adult and Elderly Subjects

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Aug 20, 2007
Registry last updated
Dec 1, 2016

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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