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InfluenzaPhase 4NCT01215669

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

A Phase 4 study testing IDflu™: Split virion inactivated influenza vaccine and Vaxigrip®: Split virion inactivated influenza vaccine in people with Influenza, run by Sanofi Pasteur, a Sanofi Company at 2 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Influenza
What is being tested?
IDflu™: Split virion inactivated influenza vaccine and Vaxigrip®: Split virion inactivated influenza vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
2 sitesSouth Korea
Study dates
Oct 2010to Apr 2011
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites

  • Study site

    Seoul, 120 752

  • Study site

    Seoul

Other trials in South Korea

About this study

Official title: Immunogenicity and Safety of Sanofi Pasteur's Intradermal Influenza Vaccine (IDflu™) in Adults and Elderly in Korea

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
Read the 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.

Conditions
Influenza
Being tested
IDflu™: Split virion inactivated influenza vaccine, Vaxigrip®: Split virion inactivated influenza vaccine
Keywords
Influenza, Influenza Virus Vaccines, Intradermal Injections
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IDflu™: Split virion inactivated influenza vaccineBiological

    Also called IDflu™

    Single dose 0.1 mL, intradermal

  • Vaxigrip®: Split virion inactivated influenza vaccineBiological

    Also called Vaxigrip®

    Single dose 0.5 mL, intramuscular

  • IDflu™: Split virion inactivated influenza vaccineBiological

    Also called IDflu™

    Single dose 0.1 mL, intradermal

  • Vaxigrip®: Split virion inactivated influenza vaccineBiological

    Also called Vaxigrip®

    Single dose 0.5 mL, intramuscular

Study groups in NCT01215669
Study groupRoleWhat they receive
Group 1: Adult Intradermal (ID) VaccineExperimentalParticipants aged 18 to 59 years will be vaccinated with IDflu™ influenza vaccine
Receives: Biological: IDflu™: Split virion inactivated influenza vaccine
Group 2: Adult Intramuscular (IM) VaccineActive comparatorParticipants aged 18 to 59 years will be vaccinated with Vaxigrip® Influenza vaccine
Receives: Biological: Vaxigrip®: Split virion inactivated influenza vaccine
Group 3: Elderly Intradermal (ID) VaccineExperimentalParticipants aged 60 years or older will be vaccinated with IDflu™ Influenza vaccine
Receives: Biological: IDflu™: Split virion inactivated influenza vaccine
Group 4: Elderly Intramuscular (IM) VaccineActive comparatorParticipants aged 60 years or older will be vaccinated with Vaxigrip® Influenza vaccine
Receives: Biological: Vaxigrip®: Split virion inactivated influenza vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 21 days post-vaccination

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

    Measured: Day 0 to up to 21 days post-vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionFeb 2011
  4. Study completionApr 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01215669
Sponsor's protocol ID
GID33
Other IDs
U111111156473
Status last verified
Sep 2018
First submitted
5 Oct 2010
Last updated
13 Sep 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 23778938

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing IDflu™: Split virion inactivated influenza vaccine and Vaxigrip®: Split virion inactivated influenza vaccine in people with Influenza, run by Sanofi Pasteur, a Sanofi Company at 2 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01215669, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2018; AzTrials last refreshed its copy on 7 Nov 2026.

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