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

Randomized, Double-Blind, Placebo-Controlled Study to Assess the Immunogenicity and Safety of a Cell-Derived Trivalent Subunit Influenza Vaccine in Subjects Aged >= 18 Years and <= 64 Years During Two Consecutive Years.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00889889

Enrollment

1270

Registered

2009-04-29

Start date

2009-05-31

Completion date

2011-01-31

Last updated

2013-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Keywords

Influenza, Phase II, Placebo-controlled

Brief summary

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

Interventions

BIOLOGICALCell-Derived Trivalent Subunit Influenza Vaccine

surface antigen, inactivated, prepared in cell cultures

BIOLOGICALPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
To assess the immunogenicity of the cell-derived subunit vaccine three weeks after vaccination, by applying the FDA requirement for influenza vaccines.	3 weeks
To assess after the first vaccination the safety and tolerability of the cell-derived subunit vaccine compared to placebo.	6 months

Secondary

Measure	Time frame
To assess the long-term immunogenicity (6 months) of the cell-derived subunit vaccine.	6 months
To assess the immunogenicity of the cell-derived subunit vaccine three weeks after revaccination.	3 weeks
To assess after the second vaccination the safety and tolerability of the cell-derived subunit vaccine.	6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026