NCT01215669

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 5, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 6, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

September 13, 2018

Status Verified

September 1, 2018

Enrollment Period

4 months

First QC Date

October 5, 2010

Last Update Submit

September 11, 2018

Conditions

Influenza

Keywords

InfluenzaInfluenza Virus VaccinesIntradermal Injections

Outcome Measures

Primary Outcomes (2)

  • Information concerning the immunogenicity of intradermal influenza vaccine in terms of seroprotection status (titers ≥40) using the Hemagglutination Inhibition (HAI) technique.

    21 days post-vaccination

  • Information regarding the safety (in terms of solicited injection site and systemic reactions) post-vaccination

    Day 0 to up to 21 days post-vaccination

Study Arms (4)

Group 1: Adult Intradermal (ID) Vaccine

EXPERIMENTAL

Participants aged 18 to 59 years will be vaccinated with IDflu™ influenza vaccine

Biological: IDflu™: Split virion inactivated influenza vaccine

Group 2: Adult Intramuscular (IM) Vaccine

ACTIVE COMPARATOR

Participants aged 18 to 59 years will be vaccinated with Vaxigrip® Influenza vaccine

Biological: Vaxigrip®: Split virion inactivated influenza vaccine

Group 3: Elderly Intradermal (ID) Vaccine

EXPERIMENTAL

Participants aged 60 years or older will be vaccinated with IDflu™ Influenza vaccine

Biological: IDflu™: Split virion inactivated influenza vaccine

Group 4: Elderly Intramuscular (IM) Vaccine

ACTIVE COMPARATOR

Participants aged 60 years or older will be vaccinated with Vaxigrip® Influenza vaccine

Biological: Vaxigrip®: Split virion inactivated influenza vaccine

Interventions

IDflu™: Split virion inactivated influenza vaccineBIOLOGICAL

Single dose 0.1 mL, intradermal

Also known as: IDflu™
Group 1: Adult Intradermal (ID) Vaccine
Vaxigrip®: Split virion inactivated influenza vaccineBIOLOGICAL

Single dose 0.5 mL, intramuscular

Also known as: Vaxigrip®
Group 2: Adult Intramuscular (IM) Vaccine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (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.

You may not qualify if:

  • 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
  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Seoul, 120 752, South Korea

Location

Unknown Facility

Seoul, South Korea

Location

Related Publications (1)

  • Hoon Han S, Hee Woo J, Weber F, Joo Kim W, Ran Peck K, Il Kim S, Hwa Choi Y, Myung Kim J. Immunogenicity and safety of Intanza((R))/IDflu((R)) intradermal influenza vaccine in South Korean adults: a multicenter, randomized trial. Hum Vaccin Immunother. 2013 Sep;9(9):1971-7. doi: 10.4161/hv.25295. Epub 2013 Jun 18.

    PMID: 23778938RESULT

MeSH Terms

Conditions

Influenza, Human

Interventions

vaxigrip

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Medical Director

    Sanofi Pasteur SA

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2010

First Posted

October 6, 2010

Study Start

October 1, 2010

Primary Completion

February 1, 2011

Study Completion

April 1, 2011

Last Updated

September 13, 2018

Record last verified: 2018-09

Locations

KR(2)