Comparison of the Safety and Immune Response of an Influenza Vaccine Made by a New Manufacturing Process With a Vaccine Made by the Traditional Manufacturing Process for Season 2003/2004

Single-blind Randomized Controlled Phase II/III Study to Investigate the Immunogenicity and Safety of an Inactivated Influenza Vaccine (Whole Virion, Vero Cell Derived) in Comparison to a Licensed Egg-derived Influenza Vaccine for Season 2003/2004

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00161837

Enrollment

Unknown

Registered

2005-09-13

Start date

2003-12-31

Completion date

2004-07-31

Last updated

2015-10-09

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

Conditions

Influenza

Keywords

Influenza, Vaccine

Brief summary

The objectives of the study are to assess the immunogenicity and safety of the inactivated influenza vaccine (whole virion, Vero cell-derived) at Day 21 and Day 180 after vaccination.

Interventions

BIOLOGICALVero Cell-derived Influenza Vaccine

BIOLOGICALEgg-derived Influenza Vaccine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

Male and female subjects will be eligible for participation in this study if they: * are \>= 18 and \<= 60 years old (for Stratum A only); * are \> 60 years old (for Stratum B only); * are in a physical condition such that the physician would have no reservations vaccinating with an influenza vaccine outside the scope of a clinical trial; * will reliably keep a daily record of symptoms; * understand the nature of the study, agree to its provisions, and give written informed consent; * if female and capable of bearing children - show a negative pregnancy test result at study entry and agree to employ adequate birth control measures for the duration of the study.

Exclusion criteria

Male and female subjects will be excluded from participation in this study if they: * have received any influenza vaccine for the 2002/2003 season and/or for the 2003/2004 season; * suffer from any kind of immunodeficiency; * suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids, chemotherapeutics) that can be expected to influence immunological functions; * have a history of inflammatory or degenerative neurological disease (e.g. Guillain Barré, multiple sclerosis); * have received a blood transfusion or immunoglobulins within one month of study entry; * have a history of any vaccine-related contraindicating event (e.g. anaphylaxis); * have a rash or dermatological condition which may interfere with injection site reaction rating; * have a known or suspected problem with drug or alcohol abuse; * are unable to lead an independent life either physically or mentally; * had administration of an investigational drug within six weeks prior to the study start; * are concurrently participating in a clinical trial; * are pregnant or lactating.

Countries

Poland

Outcome results

None listed

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