Immunogenicity and Safety of a Cell-derived Influenza Vaccine in Adults Aged >= 18 and <= 64, Plus Revaccination

Abbott

Status and phase: Completed; Phase 2

Conditions: Influenza

Treatments: Biological: Placebo; Biological: Cell-Derived Trivalent Subunit Influenza Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00889889

S203.2.004

Details and patient eligibility

About

Immunogenicity and safety of a cell-derived influenza vaccine in adults aged >= 18 and <= 64 years, plus revaccination

Enrollment: 1,270 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. Willing and able to give informed consent and able to adhere to all protocol required study procedures.
2. Men and women aged >= 18 and <= 64 years.
3. Being in good health as judged by medical history, physical examination and clinical judgment of the investigator.

Exclusion Criteria

1. Known to be allergic to constituents of the vaccine.
2. A serious adverse reaction after a previous (influenza) vaccination. Presence of any significant condition that may prohibit inclusion as determined by the investigator.
3. Having received vaccination against influenza or lab confirmed influenza within the previous six months before study vaccination.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,270 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Biological: Cell-Derived Trivalent Subunit Influenza Vaccine

2

Placebo Comparator group

Treatment:

Biological: Placebo