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InfluenzaPhase 3NCT01712984

Study of Intradermal Quadrivalent Influenza Vaccine in Adults Aged 18 Through 64 Years

A Phase 3 study testing Influenza Virus Vaccine USP Quadrivalent, (Zonal Purified Subvirion) 2012 2013 Formulation, Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone® Intradermal and Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone Intradermal in people with Influenza, run by Sanofi Pasteur, a Sanofi Company at 38 sites in United States.

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

The aim of the study is to demonstrate safety and immunogenicity of the quadrivalent influenza intradermal (QIV-ID) vaccine compared to the trivalent influenza vaccine (TIV) containing the B strain from the primary (Yamagata) lineage (TIV-ID1) and the trivalent influenza vaccine containing B strain from the alternate… Read more about this study

Who is it for?
Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for
Influenza
What is being tested?
Influenza Virus Vaccine USP Quadrivalent, (Zonal Purified Subvirion) 2012 2013 Formulation, Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone® Intradermal and Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone Intradermal
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,360 participants
Where
38 sitesUnited States
Study dates
Oct 2012to Oct 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Aged 18 through 64 years on the day of inclusion
  • Informed consent form (ICF) has been signed and dated
  • Able to attend all scheduled visits and to comply with all trial procedures. Exclusion Criteria:
  • Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination)
  • Participation at the time of trial enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
  • Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following trial vaccination
Show all 18Show fewer
  • Vaccination against influenza in the past 6 months
  • Receipt of immune globulins, blood or blood-derived products in the past 3 months
  • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as 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)
  • Known systemic hypersensitivity 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
  • History of thrombocytopenia
  • Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion
  • Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
  • Current alcohol abuse or drug addiction
  • Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
  • Identified as an Investigator or employee of the Investigator or trial center with direct involvement in the proposed trial, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed trial
  • Personal or family history of Guillain-Barré Syndrome
  • Neoplastic disease or any hematologic malignancy (except localized skin or prostate cancer that is stable at the time of vaccination in the absence of therapy, and subjects who have a history of neoplastic disease and who have been disease free for ≥ 5 years.

Who cannot join

None listed.

Trial locations and contacts

38 sites in 1 country.

38 sites in 1 country

United States38 sites

  • Study site

    Allentown, Pennsylvania, 18102

  • Study site

    Austin, Texas, 78745

  • Study site

    Bensalem, Pennsylvania, 19020

  • Study site

    Binghamton, New York, 13901

  • Study site

    Boise, Idaho, 83642

  • Study site

    Chandler, Arizona, 85224

  • Study site

    Chula Vista, California, 91911

  • Study site

    Coral Gables, Florida, 33134

  • Study site

    Dakota Dunes, South Dakota, 57049

  • Study site

    Fort Worth, Texas, 76107

  • Study site

    Fort Worth, Texas, 76135

  • Study site

    Hoover, Alabama, 35216

  • Study site

    Huntsville, Alabama, 35802

  • Study site

    Iowa City, Iowa, 52242

  • Study site

    Kansas City, Missouri, 64114

  • Study site

    Marshfield, Wisconsin, 54449

  • Study site

    Melbourne, Florida, 32935

  • Study site

    Mesa, Arizona, 85213

  • Study site

    Milford, Connecticut, 06460

  • Study site

    Mt. Pleasant, South Carolina, 29464

  • Study site

    Omaha, Nebraska, 68134

  • Study site

    Overland Park, Kansas, 66212

  • Study site

    Phoenix, Arizona, 85020

  • Study site

    Pinellas Park, Florida, 33781

  • Study site

    Rochester, New York, 14609

  • Study site

    Rochester, New York, 14621

  • Study site

    Sacramento, California, 95816

  • Study site

    Salt Lake City, Utah, 84109

  • Study site

    Salt Lake City, Utah, 84121

  • Study site

    San Angelo, Texas, 76904

  • Study site

    San Diego, California, 92103

  • Study site

    South Miami, Florida, 33143

  • Study site

    Springfield, Missouri, 65802

  • Study site

    St Louis, Missouri, 63104

  • Study site

    Tucson, Arizona, 85704

  • Study site

    Warwick, Rhode Island, 02886

  • Study site

    West Jordan, Utah, 84088

  • Study site

    Wichita, Kansas, 67207

Other trials in United States

About this study

Official title: Immunogenicity and Safety Trial of Quadrivalent Influenza Vaccine Administered by Intradermal Route in Adult Subjects Aged 18 Through 64 Years

The aim of the study is to demonstrate safety and immunogenicity of the quadrivalent influenza intradermal (QIV-ID) vaccine compared to the trivalent influenza vaccine (TIV) containing the B strain from the primary (Yamagata) lineage (TIV-ID1) and the trivalent influenza vaccine containing B strain from the alternate (Victoria) lineage (TIV-ID2) vaccines in producing protection against four strains of influenza virus.

Primary Objective:

Read more
  • To demonstrate that QIV-ID induces an immune response (as assessed by hemagglutination inhibition (HAI) geometric mean titers (GMTs) and seroconversion rates) that is non-inferior to responses induced by TIV-ID1 and TIV-ID2 for the 4 virus strains at 28 days post-vaccination.

Secondary Objectives:

  • To demonstrate that each B strain in QIV-ID induces an immune response (as assessed by HAI GMTs and seroconversion rates) that is superior to the response induced by the TIV-ID that does not contain the corresponding B strain.
  • To describe the rate of post-vaccination seroprotection induced by QIV-ID and TIV-ID.
  • To describe post-vaccination immunogenicity stratified by age (18-49 years and 50-64 years), race, ethnicity, gender, previous vaccination status, and baseline seropositivity status.
  • To describe the safety profile for subjects who receive QIV-ID and TIV-ID.

Observational Objectives:

  • To demonstrate non-inferiority of QIV-ID compared to TIV-ID in terms of all Grade 2 or Grade 3 solicited systemic reactions combined
  • To demonstrate non-inferiority of QIV-ID compared to TIV-ID in terms of all Grade 3 solicited injection site reactions combined.
Read the detailed description

All participants will receive a single dose of their assigned vaccine on Day 0. A subset of the participants will be assessed for immunologic response on Day 0 before vaccination and Day 28 after vaccination. All subjects will be monitored for safety for up to 6 months after vaccination.

Conditions
Influenza
Being tested
Influenza Virus Vaccine USP Quadrivalent, (Zonal Purified Subvirion) 2012 2013 Formulation, Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone® Intradermal, Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone Intradermal
Keywords
Influenza, Fluzone® Intradermal vaccine, Influenza Virus Vaccine USP Quadrivalent, Influenza Virus Vaccine USP Trivalent Types A and B
Medical subject headings
Influenza, Human

What participants receive

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

  • Influenza Virus Vaccine USP Quadrivalent, (Zonal Purified Subvirion) 2012 2013 FormulationBiological

    Also called QIV ID

    0.1mL, Intradermal

  • Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone® IntradermalBiological

    Also called Fluzone® Intradermal

    0.1mL, Intradermal

  • Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone IntradermalBiological

    Also called Fluzone® Intradermal

    0.1mL, Intradermal

Study groups in NCT01712984
Study groupRoleWhat they receive
QIV ID Vaccine GroupExperimentalParticipants will receive the intradermal quadrivalent influenza vaccine
Receives: Biological: Influenza Virus Vaccine USP Quadrivalent, (Zonal Purified Subvirion) 2012 2013 Formulation
TIV ID1 Vaccine GroupActive comparatorParticipants will receive the trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage
Receives: Biological: Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone® Intradermal
TIV ID2 GroupActive comparatorParticipants will receive the intradermal trivalent influenza vaccine containing B strain from the alternate (Victoria) lineage
Receives: Biological: Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone Intradermal

What is being measured

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

  1. Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route

    Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay.

    Measured: Day 28 post-vaccination

  2. Number of Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route

    Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay. Seroconversion was defined as titer< 10 (1/dil) on Day 0 and post injection titer ≥ 40 (1/dil) on Day 28, or titer ≥10 (1/dil) on Day 0 and a ≥4 fold increase in titer (1/dil) on Day 28).

    Measured: Day 28 post-vaccination

Secondary outcomes (3)

  1. Geometric Mean Titers Against the Influenza Virus Antigens Before and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route

    Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay.

    Measured: Day 0 (pre-vaccination) and Day 28 post-vaccination

  2. Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before (Baseline) and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route

    Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay. Seroprotection was defined as titer ≥ 40 [1/dil] at baseline and 28 days after vaccination.

    Measured: Day 0 (pre-vaccination) and Day 28 post-vaccination

  3. Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route

    Solicited injection site: Pain, Erythema, Swelling, Induration, Ecchymosis, and Pruritus; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 injection site: Pain and Pruritus Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis >100 mm. Grade 3 systemic reactions: Fever ≥39˚C; Headache, Malaise, Myalgia, and Shivering Significant preventing daily activity.

    Measured: Day 0 up to Day 7 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 posted24 Oct 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionJun 2013
  4. Study completionOct 2013

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
3,360 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01712984
Sponsor's protocol ID
QID01
Other IDs
U1111-1124-8066
Status last verified
Apr 2015
First submitted
22 Oct 2012
Last updated
7 May 2015
Data monitoring committee
No

Publications

  • Gorse GJ, Falsey AR, Ozol-Godfrey A, Landolfi V, Tsang PH. Safety and immunogenicity of a quadrivalent intradermal influenza vaccine in adults. Vaccine. 2015 Feb 25;33(9):1151-9. doi: 10.1016/j.vaccine.2015.01.025. Epub 2015 Jan 19.

    PubMed 25613721

  • Small RD, Ozol-Godfrey A, Yan L. On the use of nonparametric tests for comparing immunological Reverse Cumulative distribution curves (RCDCs). Vaccine. 2019 Oct 16;37(44):6737-6742. doi: 10.1016/j.vaccine.2019.09.007. Epub 2019 Sep 16.

    PubMed 31537446

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Influenza Virus Vaccine USP Quadrivalent, (Zonal Purified Subvirion) 2012 2013 Formulation, Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone® Intradermal and Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone Intradermal in people with Influenza, run by Sanofi Pasteur, a Sanofi Company at 38 sites in United States.

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 18 inclusion and 0 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 7 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route (time frame: Day 28 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 NCT01712984, which also lists 2 linked publications.

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 7 May 2015.

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