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

Randomized, Double-Blind Study to Assess Safety, Immunogenicity, and Lot Consistency of Solvay's Cell-Derived Influenza Vaccine and Its Non-Inferiority Compared to Influvac®.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00999206

Enrollment

3138

Registered

2009-10-21

Start date

2010-01-31

Completion date

2010-08-31

Last updated

2011-08-26

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

Conditions

Influenza

Keywords

Influenza, Vaccine, CHMP criteria

Brief summary

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

Interventions

BIOLOGICALInfluenza Vaccine

surface antigen, inactivated, prepared in cell cultures

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. Female or male subjects \>= 18 years of age (adults \>= 18 to \< =60 years of age or elderly \>= 61 years of age). 2. Willing and able to give informed consent before any protocol procedures are performed. 3. Able to adhere to visit schedules and all protocol required study procedures. 4. 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

1. 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). 2. Presence of any significant condition that may prohibit inclusion as determined by the Investigator. 3. A serious adverse reaction after a previous (influenza) vaccination. 4. A history of Guillain-Barré syndrome. 5. Known to be allergic to constituents of the study vaccines.

Design outcomes

Primary

Measure	Time frame
Anti-HA antibody titers and derived parameters seroprotection, seroconversion and fold increase	3 weeks

Countries

Australia, New Zealand

Outcome results

None listed

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