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Safety of a Influenza Vaccine Produced Either in Mammalian Cell Culture or in Embryonated Hen Eggs in Adults and Elderly With and Without Underlying Medical Conditions, and Immunogenicity in a Subset of Subjects With Underlying Medical Conditions

NCT00560066 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1398

Last updated 2016-02-17

Study results available
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Summary

Evaluation of the safety of Trivalent Subunit Influenza Vaccine Produced either in Mammalian Cell Culture or in embryonated Hen Eggs in subjects 18 years of age and above with and without underlying medical conditions and evaluation of the immunogenicity in a subset of subjects with underlying medical conditions, compared to an egg-based vaccine in a post marketing setting.

Conditions

Interventions

BIOLOGICAL

Cell-derived influenza vaccine

1 dose of 0.5 mL in the deltoid region of the non-dominant arm

BIOLOGICAL

Egg-derived influenza vaccine

1 dose of 0.5 mL in the deltoid region of the non-dominant arm

Sponsors & Collaborators

  • Novartis Vaccines

    lead INDUSTRY

Principal Investigators

  • Novartis Vaccines · Novartis Vaccines

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00560066 on ClinicalTrials.gov