Lot-to-Lot Consistency Study of the Investigational, Inactivated, Split-Virion Influenza Vaccine in Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary objective of this trial is to demonstrate the equivalence, in terms of immunogenicity, of three different industrial lots of the investigational vaccine thereby supporting consistency of the manufacturing process.

Secondary Objectives:

Immunogenicity

To demonstrate that the investigational vaccine induces an immune response at least as good as the one induced by the reference vaccine, in terms of antibody titers.

To assess the immunogenicity of the investigational vaccine using parameters defined in the European Medicines Agency (EMEA) Note for Guidance (CPMP/BWP/214/96).

Safety:

To demonstrate that the investigational vaccine is at least as well tolerated as the reference vaccine, in terms of defined safety profile.

To describe the safety profile after vaccination.

Comfort of the vaccination assessment:

To assess the pain immediately after the injection using a Verbal Rating Scale. To describe the vaccination comfort after the injection using a -Patient-Reported Outcome questionnaire: the Vaccination Comfort Questionnaire.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Immunogenicity, Safety, Reactogenicity, Efficacy, Effectiveness and Lot Consistency of FluBlok

NCT00539981

Influenza

COMPLETED PHASE3

A Study of the Immunogenicity and Safety of the 2007-2008 Influenza Vaccine

NCT00491257

Influenza Orthomyxoviridae Infections

COMPLETED PHASE2

A Study of the Immunogenicity and Safety of the 2006-2007 Influenza Vaccine

NCT00343681

Influenza Orthomyxoviridae Infections

COMPLETED PHASE2

Safety and Immunogenicity of Trivalent Split Influenza Vaccine Using the Strain Composition 2007/2008

NCT00498303

Seasonal Influenza Vaccine

COMPLETED PHASE3

Safety and Immunogenicity of Trivalent Split Influenza Vaccine Using the Strain Composition 2008/2009

NCT00735410

Seasonal Influenza, Vaccine

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Orthomyxoviridae Infection Influenza Myxovirus Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Lot 1

Group Type EXPERIMENTAL

Inactivated Split-virion influenza vaccine

Intervention Type BIOLOGICAL

Vaccine Lot 1

2

Lot 2

Group Type EXPERIMENTAL

Inactivated Split-virion influenza vaccine

Intervention Type BIOLOGICAL

Vaccine Lot 2

3

Lot 3

Group Type EXPERIMENTAL

Inactivated Split-virion influenza vaccine

Intervention Type BIOLOGICAL

Vaccine Lot 3

4

Control

Group Type ACTIVE_COMPARATOR

Inactivated Split-virion influenza vaccine

Intervention Type BIOLOGICAL

Control Vaccine

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Inactivated Split-virion influenza vaccine

Vaccine Lot 1

Intervention Type BIOLOGICAL

Inactivated Split-virion influenza vaccine

Vaccine Lot 2

Intervention Type BIOLOGICAL

Inactivated Split-virion influenza vaccine

Vaccine Lot 3

Intervention Type BIOLOGICAL

Inactivated Split-virion influenza vaccine

Control Vaccine

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Vaxigrip

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Aged 18 to 60 years on the day of inclusion.
* Informed consent form signed.
* Able to attend all scheduled visits and to comply with all trial procedures.
* For a woman, inability to bear a child or negative urine pregnancy test at the first visit.

Exclusion Criteria

* Systemic hypersensitivity to egg proteins, chick proteins, or any of the vaccine components, in particular, neomycin, formaldehyde, and octoxinol 9, or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
* Febrile illness (oral temperature \>= 37.5°C, or rectal equivalent temperature \>= 38.0°C) on the day of inclusion.
* Participation in another clinical trial in the 4 weeks preceding the trial vaccination.
* Planned participation in another clinical trial during the present trial period.
* Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.
* Unstable chronic illness (defined as illness requiring hospitalization or a clinically significant change in medication in the 12 weeks prior to inclusion) at a stage that could interfere with trial conduct or completion.
* Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures.
* Blood or blood-derived products received in the past 3 months.
* Any vaccination in the 4 weeks preceding the trial vaccination.
* Vaccination planned in the 4 weeks following the trial vaccination.
* Previous vaccination against influenza (in the previous 6 months).
* Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
* Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes