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OpenTrials
Completed

NCT Number: NCT00354016

Safety and Immunogenicity of Preservative Free Inactivated Split Influenza Vaccine, Using the Strain Composition 2006/2007 in Non-Elderly Adult and Elderly Subjects

Due to antigenic changes of influenza viruses, the virus strains used in influenza vaccines are adjusted every year according to WHO (World Health Organization) and CHMP (Committee for Medicinal Products for Human Use) recommendations. Immunogenicity and tolerability of the newly composed vaccines are subject for evaluation in a yearly clinical trial in non-elderly 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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Werksarztzentrum Herborn, Westerwaldstr 36,, Herborn, Germany

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy adults aged >18 years

Exclusion criteria

  • serious chronic diseases or significant acute infections requiring systemic antibiotic treatment
  • history of any anaphylaxis, serious vaccine reactions
  • hypersensitivity against vaccine components
  • history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
  • known or suspected impairment/alteration of immune function
  • more than one injection of influenza vaccine received or laboratory confirmed influenza disease
  • within last 6 months: influenza vaccination received

Treatment and study plan

preservative free inactivated split influenza vaccine using the strain composition 2006/2007

Biological

Primary outcomes

  1. antibody titers to each influenza strain measured by hemagglutination inhibition (HI) test on Day 0 and on Day 21

Secondary outcomes

  1. safety of a single IM dose of the split influenza vaccine using solicited local and systemic reactions and adverse event reporting

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Collaborators

  • Novartis Vaccines

Registry information

Official study title

A Phase III, Multicenter, Uncontrolled, Open-Label Study to Demonstrate Safety and Immunogenicity of a Commercially Available Preservative Free Inactivated Split Influenza Vaccine, Using the Strain Composition 2006/2007 When Administered to Non-Elderly Adult and Elderly Subjects

Important dates

Study start
2006
First posted
Jul 19, 2006
Registry last updated
Mar 13, 2007

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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