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Study of Sanofi Pasteur's Intradermal Influenza Vaccine (IDflu™) in Adults and Elderly in Korea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01215669
First received: October 5, 2010
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

This study is designed to assess the immunogenicity and safety of the 2010-2011 NH season formulation of intradermal (ID) influenza vaccine as part of a post registration commitment.

Objectives:

  • For all groups, to evaluate compliance, in terms of immunogenicity, of the corresponding strength of the intradermal (ID) or intramuscular (IM) influenza vaccine Northern Hemisphere (NH) 2010 2011 formulation with the requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96
  • For all groups, to describe the safety

Condition Intervention Phase
Influenza
Biological: IDflu™: Split virion inactivated influenza vaccine
Biological: Vaxigrip®: Split virion inactivated influenza vaccine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of Sanofi Pasteur's Intradermal Influenza Vaccine (IDflu™) in Adults and Elderly in Korea

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Information concerning the immunogenicity of intradermal influenza vaccine in terms of seroprotection status (titers ≥40) using the Hemagglutination Inhibition (HAI) technique. [ Time Frame: 21 days post-vaccination ] [ Designated as safety issue: No ]
  • Information regarding the safety (in terms of solicited injection site and systemic reactions) post-vaccination [ Time Frame: Day 0 to up to 21 days post-vaccination ] [ Designated as safety issue: Yes ]

Enrollment: 240
Study Start Date: October 2010
Study Completion Date: April 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1: Adult Intradermal (ID) Vaccine
Participants aged 18 to 59 years will be vaccinated with IDflu™ influenza vaccine
Biological: IDflu™: Split virion inactivated influenza vaccine
Single dose 0.1 mL, intradermal
Other Name: IDflu™
Active Comparator: Group 2: Adult Intramuscular (IM) Vaccine
Participants aged 18 to 59 years will be vaccinated with Vaxigrip® Influenza vaccine
Biological: Vaxigrip®: Split virion inactivated influenza vaccine
Single dose 0.5 mL, intramuscular
Other Name: Vaxigrip®
Experimental: Group 3: Elderly Intradermal (ID) Vaccine
Participants aged 60 years or older will be vaccinated with IDflu™ Influenza vaccine
Biological: IDflu™: Split virion inactivated influenza vaccine
Single dose 0.1 mL, intradermal
Other Name: IDflu™
Active Comparator: Group 4: Elderly Intramuscular (IM) Vaccine
Participants aged 60 years or older will be vaccinated with Vaxigrip® Influenza vaccine
Biological: Vaxigrip®: Split virion inactivated influenza vaccine
Single dose 0.5 mL, intramuscular
Other Name: Vaxigrip®

Detailed Description:

All participants will receive a single dose of study vaccine on Day 0. Immunogenicity data will be collected before vaccination and on Day 21 post vaccination. Safety will be assessed throughout the study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 18 years and over on the day of inclusion
  • 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.

Exclusion Criteria:

  • 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 seasonal influenza vaccination within the previous 6 months (other than pandemic H1N1 influenza vaccine)
  • Receipt of an influenza vaccine (either seasonal or pandemic 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
  • History of thrombocytopenia, contraindicating intramuscular (IM) vaccination
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination, under the investigator's judgment
  • Receipt of any vaccine in the 4 weeks preceding the trial vaccination
  • Planned receipt of any vaccine in the 3 weeks following the trial vaccination
  • 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
  • Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
  • Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
  • Identified as employees of the Investigator or study department, with direct involvement in the proposed study or other studies under the direction of that Investigator or study department as well as family members (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01215669

Locations
Korea, Republic of
Seoul, Korea, Republic of, 120 752
Seoul, Korea, Republic of
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur SA
  More Information

Additional Information:
No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01215669     History of Changes
Other Study ID Numbers: GID33, U111111156473
Study First Received: October 5, 2010
Last Updated: January 10, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Sanofi:
Influenza
Influenza Virus Vaccines
Intradermal Injections

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014