Immunogenicity of a Split, Cell-Based, Inactivated, Trivalent Influenza Vaccine in Healthy Adult Subjects

Influenza Clinical Trial

Official title:

Immunogenicity of Two Dosages of a Split, Cell-Based, Inactivated, Trivalent Influenza Vaccine Administered in Healthy Adult Subjects Aged 18 to 49 Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00845429
• Other study ID #: GCE03
• Status: Completed
• Phase: Phase 2
• First received: February 13, 2009
• Last updated: December 13, 2012
• Start date: October 2007
• Est. completion date: November 2008

Study information

• Verified date: December 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Primary Objective:

To describe the immune response to a single administration of 2 formulations of the investigational cell-based influenza vaccines in healthy adult subjects.

Secondary Objective:

To describe the safety following a single administration of 2 formulations of the investigational cell-based influenza vaccines in healthy adult subjects.

Description:

This is a multi-center study in healthy adult subjects. All subjects will receive a single dose of one of the influenza vaccine formulations and will provide blood samples for immunogenicity assessment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 729
• Est. completion date: November 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 49 Years

Eligibility

Inclusion Criteria :

• Healthy male or female subject, aged = 18 to < 50 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 of childbearing potential: a negative urine pregnancy test and documented use of an effective method of contraception or abstinence for at least four weeks pre vaccination and up until three weeks post-vaccination

Exclusion Criteria :

• Subject currently breast-feeding.

• Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial vaccination.

• Planned participation in another clinical trial during the present trial period.

• Prior participation in the Phase I trial of FLU INTERPAN (PER.C6) vaccine (study GCE01).

• Congenital or history of acquired immunodeficiency, or immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months.

• Systemic corticosteroid therapy as except the use of topical or inhalant corticosteroids

• Systemic hypersensitivity to egg proteins, chicken proteins, or to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.

• Chronic illness at a stage that could interfere with trial conduct or completion (chronic illness may include, but is not limited to, cardiac, renal or auto-immune disorders, or diabetes).

• Receipt of blood or blood-derived products in the 3 months preceding vaccination.

• Receipt of any vaccination in the 4 weeks preceding vaccination, or planned receipt of any vaccination in the 4 weeks following the trial vaccination.

• History of influenza infection (confirmed either clinically, serologically or microbiologically) within the 6 months preceding vaccination.

• Previous vaccination against influenza (in the 6 months preceding the trial vaccination).

• Planned receipt of any other 2007-2008 influenza vaccine.

• Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination.

• Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.

• History of Guillain-Barré syndrome

• Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures

• Any other condition which in the opinion of the investigator would pose a health risk to the participant or interfere with the evaluation of the vaccine.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human
• Myxovirus Infection
• Orthomyxoviruses

Intervention

Biological:
• Influenza virus vaccine - cell based (2007-2008 Formulation)
0.5 mL, Intramuscular
• Influenza virus vaccine - cell-based (2007-2008 Formulation)
1.0 mL, Intramuscular
• Influenza virus vaccine (2007-2008 Formulation)
0.5 mL, Intramuscular

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Summary of the Pre- and Post-Vaccination Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigens.		Days 0 and 21 post-vaccination	No
Primary	Percentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Before and Post-vaccination.	Seroprotection was defined as a titer = 40 1/dil, and determined in participants with a valid serology result for the particular Flu strain, including results reported as less than lower limit of quantitation (LLOQ)	Day 21 post-vaccination	No
Primary	Percentage of Participants Achieving Seroconversion or Significant Increase at Day 21 Following Vaccination With Influenza Vaccine.	Seroconversion: For participants with a Day 0 pre-vaccination titer < 10 (1/dil), titer = 40 (1/dil) on Day 21.; Significant Increase: For participants with a Day 0 pre-vaccination titer = 10 (1/dil), = 4-fold increase of titer on Day 21.	Day 21 post-vaccination	No
Secondary	Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine.	Solicited Injection Site Reactions: Pain, erythema or redness, swelling, ecchymosis, and induration.; Solicited Systemic Reactions: Fever (temperature), headache, malaise, myalgia, and rigors.	Day 0 up to Day 7 post-vaccination	No

External Links

•   Link
•   Link