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Clinical Trials/NCT00342940
NCT00342940
Withdrawn
Phase 2

A Phase II, Open-Label, Uncontrolled, Single Center Study to Evaluate Safety and Immunogenicity of a Commercially Available Surface Antigen, Inactivated Influenza Vaccine, Formulation 2006-2007, When Administered to Non-Elderly Adult and Elderly Subjects

Novartis1 site in 1 countryOctober 2006
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ConditionsInfluenza

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Influenza
Sponsor
Novartis
Locations
1
Primary Endpoint
CHMP criteria for evaluation of flu vaccines e.g Seroprotection, GMR's and Seroconversion rate at day 21 following vaccination
Status
Withdrawn
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The present study aims to evaluate safety and immunogenicity of one dose of a commercially available Surface Antigen, Inactivated Influenza Vaccine, Formulation 2006-2007, in non-elderly adult and elderly subjects.

Registry
clinicaltrials.gov
Start Date
October 2006
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Novartis

Eligibility Criteria

Inclusion Criteria

  • •Male and female subjects 18 years of age or older

Exclusion Criteria

  • •any auto-immune disease or other serious acute, chronic or progressive disease
  • •hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine
  • •known or suspected (or high risk of developing) impairment/alteration of immune function
  • •within the past 7 days any acute disease or infections requiring systemic antibiotic or antiviral therapy
  • •history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine

Outcomes

Primary Outcomes

CHMP criteria for evaluation of flu vaccines e.g Seroprotection, GMR's and Seroconversion rate at day 21 following vaccination

Secondary Outcomes

  • Number and percentage of subjects with at least one local reaction between Day 0 and Day 3 after vaccine injection.
  • Number and percentage of subjects with at least one systemic reaction between Day 0 and Day 3 after vaccine injection.
  • Number and percentage of subjects with at least one adverse event between Day 0 and the study termination visit (Day 21, window: 20-24).

Study Sites (1)

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