Immunogenicity and Safety of a Vaccine Against Influenza (2010-2011 Northern Hemisphere Season, Intramuscular Route)

NCT01121822 | Completed Phase 3

• 3 other identifiers: GRT902009-017690-38UTN: U1111-1112-8285
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 3

Brief Summary

The aim of this study is to evaluate the new formulation of the influenza vaccine for the 2010-2011 Northern Hemisphere (NH) season in terms of immunogenicity and safety in the corresponding population and to check its compliance with the Committee for Proprietary Medicinal Products (CPMP) Note for Guidance (NfG) CPMP/BWP/214/96 Objectives:

• To evaluate the compliance, in terms of immunogenicity, of the influenza vaccine (split virion, inactivated) NH 2010-2011 formulation with the requirements of the Committee for Proprietary Medicinal Products (CPMP) Note for Guidance (NfG) CPMP/BWP/214/96 in both age groups
• To describe the safety of the influenza vaccine (split virion, inactivated) NH 2010-2011 formulation in both age groups

Conditions

Influenza

Keywords

Influenza; Influenza vaccine; Influenza virus; Intramuscular

Outcome Measures

Primary Outcomes (2)

• To provide information concerning the immunogenicity of the Influenza virus vaccine (Split Virion, Inactivated), Northern Hemisphere 2010-2011 Formulation.

  21 days post-vaccination

• Safety: To provide information concerning the safety of the Influenza virus vaccine (Split Virion, Inactivated), Northern Hemisphere 2010-2011 Formulation.

  21 days post-vaccination

Study Arms (2)

Group 1

EXPERIMENTAL

Participants at age 18 to 59 years

Biological: Influenza virus vaccine (split virion, inactivated)

Group 2

EXPERIMENTAL

Participants at age 60 years or older

Biological: Influenza virus vaccine (split virion, inactivated)

Interventions

Influenza virus vaccine (split virion, inactivated) BIOLOGICAL

0.5 mL, Intramuscular

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent form has been signed and dated
• Able to attend all scheduled visits and to comply with all trial procedures
• For a woman of childbearing potential, use of an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination
• Entitled to national social security.

You may not qualify if:

• Febrile illness (temperature ≥ 38.0°C) or moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination
• Known systemic hypersensitivity to eggs, chicken proteins, neomycin, formaldehyde and octoxynol-9, or to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
• Known pregnancy, or a positive urine pregnancy test
• Currently breastfeeding a child
• History of pandemic H1N1 influenza vaccination
• History of clinically or laboratory confirmed pandemic H1N1 influenza infection
• History of influenza vaccination within the previous 6 months (other than pandemic H1N1 influenza vaccine)
• Receipt of an adjuvanted influenza vaccine in a clinical trial within the previous 12 months
• Known or suspected congenital or acquired immunodeficiency, resulting for example from:
• End-stage renal disease requiring dialysis
• Active neoplastic disease or active hematologic malignancy
• Receipt of immunosuppressive therapy or other immune-modifying drugs such as, but not limited to: anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
• History of seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C
• Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
• Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (3)

Unknown Facility

Gières, 38610, France

Location

Unknown Facility

Montpellier, 34094, France

Location

Unknown Facility

Rouffach, 68250, France

Location

Related Links

• Related Info

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Medical Director

  Sanofi Pasteur Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2010
• First Posted: May 12, 2010
• Study Start: May 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: October 6, 2015

Record last verified: 2015-10

Locations

FR (3)