Study Measuring the Safety, Immunogenicity and Lot Consistency of Cell Derived Influenza Vaccine

Abbott

Status and phase

Completed

Phase 3

Conditions

Influenza

Treatments

Biological: Influenza Vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00999206

S203.3.013

Details and patient eligibility

About

A phase 3 study to obtain additional safety and immunogenicity data on Solvay's cell-derived seasonal trivalent subunit influenza vaccine in adult and elderly subjects without significant illnesses and to demonstrate consistency of the immunogenicity of the three lots of the same vaccine, comparison of cell-derived vaccine to Solvay's egg-derived vaccine including assessment of non-inferior immunogenicity

Enrollment

3,138 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Female or male subjects >= 18 years of age (adults >= 18 to < =60 years of age or elderly >= 61 years of age).
Willing and able to give informed consent before any protocol procedures are performed.
Able to adhere to visit schedules and all protocol required study procedures.
Being in good health as determined by medical history, physical examination and clinical judgment of the investigator (subjects may have underlying illnesses such as hypertension, diabetes, ischemic heart disease or hypothyroidism, as long as the disease is well controlled. If on medication for a condition, the medication dose must have been stable for at least 3 months preceding study vaccination).

Exclusion Criteria

Influenza vaccination or laboratory confirmed influenza infection within six months preceding the date of study vaccination or planning an influenza vaccination during the three weeks after study vaccination (i.e. between study Day 1 and study Day 22).
Presence of any significant condition that may prohibit inclusion as determined by the Investigator.
A serious adverse reaction after a previous (influenza) vaccination.
A history of Guillain-Barré syndrome.
Known to be allergic to constituents of the study vaccines.