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InfluenzaPhase 3NCT01240746

Study of Quadrivalent Influenza Vaccine Among Children

A Phase 3 study testing Licensed 2010-2011 Trivalent Influenza Vaccine, No Preservative, Investigational Trivalent Influenza Vaccine with alternate B strain, No Preservative and Quadrivalent Influenza Vaccine, No Preservative in people with Influenza, run by Sanofi Pasteur, a Sanofi Company at 67 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 evaluate a prototype quadrivalent influenza vaccine (QIV), the licensed 2010-2011 trivalent influenza vaccine (TIV) containing the primary B strain (B1), and the investigational TIV containing the alternate B (B2) strain in children. Read more about this study

Who is it for?
Ages 6 months to 8 yearsHealthy volunteers can take part
Conditions the study is for
Influenza
What is being tested?
Licensed 2010-2011 Trivalent Influenza Vaccine, No Preservative, Investigational Trivalent Influenza Vaccine with alternate B strain, No Preservative and Quadrivalent Influenza Vaccine, No Preservative
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,363 participants
Where
67 sitesUnited States
Study dates
Nov 2010to Feb 2012
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 6 months to 8 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Subject is 6 months to < 9 years of age on the day of inclusion.
  • Parent/guardian is willing and able to attend scheduled visits and to comply with the study procedures during the entire duration of the study.
  • Subject is in reasonably good health as assessed by the Investigator.
  • Informed consent is granted by the parent(s) or other legally acceptable representative; assent by subjects 7 to < 9 years of age.
  • For subjects 6 months to < 24 months of age, born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg (5.5 lbs).

Who cannot join

  • History of allergy to egg proteins or any constituents of the vaccine.
  • History of serious adverse reaction to any influenza vaccine.
  • Any vaccination scheduled between Visit 1 and Visit 2 (or Visit 1 and Visit 3 for those requiring two doses).
  • Receipt of any vaccine in the 4 weeks preceding the first study vaccination.
  • Participation in another interventional clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first study vaccination or during the course of the study.
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination.
Show all 15Show fewer
  • Any condition that in the opinion of the Investigator would pose a health risk to the subject if enrolled or could interfere with the evaluation of the vaccine.
  • Personal history of Guillain-Barré syndrome.
  • 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).
  • Personal or immediate family history of congenital immune deficiency.
  • Personal developmental delay, neurologic disorder, or seizure disorder.
  • Any chronic illness that, in the opinion of the Investigator, is not well controlled and may interfere with trial conduct or completion, or with assessment of adverse events.
  • Known seropositivity for human immunodeficiency virus, hepatitis B, or hepatitis C.
  • Receipt of blood or blood-derived products (including immunoglobulin therapy) in the past 3 months, which might interfere with assessment of the immune response.
  • Employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members of the employees or the Investigator.

Trial locations and contacts

67 sites in 1 country.

67 sites in 1 country

United States67 sites

  • Study site

    Akron, Ohio, 44311

  • Study site

    Arkansas City, Kansas, 67005

  • Study site

    Austin, Texas, 78705

  • Study site

    Bardstown, Kentucky, 40004

  • Study site

    Barnwell, South Carolina, 26812

  • Study site

    Binghamton, New York, 13901

  • Study site

    Boca Raton, Florida, 33432

  • Study site

    Cary, North Carolina, 27518

  • Study site

    Chandler, Arizona, 85224

  • Study site

    Chandler, Arizona, 85225

  • Study site

    Charlottesville, Virginia, 22902

  • Study site

    Clarksville, Tennessee, 37043

  • Study site

    Cleveland, Ohio, 44121

  • Study site

    Colorado Spring, Colorado, 80922

  • Study site

    Columbia, Maryland, 21045

  • Study site

    Columbus, Ohio, 43212

  • Study site

    Crestview Hills, Kentucky, 41017

  • Study site

    Denver, Colorado, 80239

  • Study site

    Dothan, Alabama, 36305

  • Study site

    Fort Worth, Texas, 76107

  • Study site

    Fort Worth, Texas, 76135

  • Study site

    Houston, Texas, 77074

  • Study site

    Jacksonville, Florida, 32216

  • Study site

    Kansas City, Missouri, 64114

  • Study site

    Katy, Texas, 77450

  • Study site

    Kingsport, Tennessee, 37664

  • Study site

    Las Vegas, Nevada, 89104

  • Study site

    Layton, Utah, 84041

  • Study site

    Lexington, Kentucky, 40509

  • Study site

    Little Rock, Arkansas, 72205

  • Study site

    Los Angeles, California, 90036

  • Study site

    Marietta, Georgia, 30625

  • Study site

    Marshfield, Wisconsin, 54449

  • Study site

    Melbourne, Florida, 32935

  • Study site

    Mesa, Arizona, 85203

  • Study site

    Mesa, Arizona, 85213

  • Study site

    Metairie, Louisiana, 70006

  • Study site

    Miami Beach, Florida, 33141

  • Study site

    Midlothian, Virginia, 23113

  • Study site

    Mt. Pleasant, South Carolina, 29464

  • Study site

    Murray, Utah, 84107

  • Study site

    Newton, Kansas, 67114

  • Study site

    Orem, Utah, 84057

  • Study site

    Overland Park, Kansas, 66202

  • Study site

    Pittsburgh, Pennsylvania, 15220

  • Study site

    Pittsburgh, Pennsylvania, 15227

  • Study site

    Ponte Vedra, Florida, 32081

  • Study site

    Portland, Oregon, 97203

  • Study site

    Provo, Utah, 84604

  • Study site

    Ridgefield, Connecticut, 06877

  • Study site

    Salt Lake City, Utah, 84109

  • Study site

    Salt Lake City, Utah, 84121

  • Study site

    Salt Lake City, Utah, 84124

  • Study site

    San Diego, California, 92103

  • Study site

    San Diego, California, 92108

  • Study site

    Sarasota, Florida, 34231

  • Study site

    Sarasota, Florida, 34239

  • Study site

    Scottsdale, Arizona, 85258

  • Study site

    Scranton, Pennsylvania, 18510

  • Study site

    South Jordan, Utah, 84095

  • Study site

    South Miami, Florida, 33143

  • Study site

    St Louis, Missouri, 63141

  • Study site

    Warwick, Rhode Island, 02886

  • Study site

    West Jordan, Utah, 84088

  • Study site

    Wichita, Kansas, 67205

  • Study site

    Wichita, Kansas, 67207

  • Study site

    Williamsburg, Virginia, 23185

Other trials in United States

About this study

Official title: Safety and Immunogenicity Among Children Administered Quadrivalent Influenza Vaccine

The aim of the study is to evaluate a prototype quadrivalent influenza vaccine (QIV), the licensed 2010-2011 trivalent influenza vaccine (TIV) containing the primary B strain (B1), and the investigational TIV containing the alternate B (B2) strain in children.

Primary Objective:

Read more

To demonstrate non-inferiority of antibody responses to QIV compared with licensed 2010-2011 TIV (containing the primary B strain) and investigational TIV (containing the alternate B strain) as assessed by geometric mean titer (GMT) ratios for each of the four virus strains separately among children aged 6 months to less than 9 years of age

Secondary Objective:

To demonstrate superiority of antibody responses to each B strain in QIV compared with antibody titers following vaccination with the TIV that does not contain the corresponding B strain, as assessed by GMT ratios and seroconversion rates.

Observational Objective:

To describe the safety profile of QIV among subjects 6 months to less than 9 years of age, as assessed by solicited injection site and systemic adverse events (AEs) collected for 7 days post-vaccination, unsolicited adverse events collected from 21 days post-vaccination, and adverse events of special interest and serious adverse events (SAEs) collected from Visit 1 to Visit 2.

Read the detailed description

Participants will receive a single dose of their assigned vaccine during Visit 1. For those requiring two doses of influenza vaccine, as per Advisory Committee on Immunization Practices (ACIP) guidance, a second dose of the assigned vaccine will be administered at Visit 2. All participants will be followed up for safety (up to 6 months post final vaccination) and for immunogenicity up to Day 28 post-vaccination (Visit 2 or Visit 3, as appropriate).

Conditions
Influenza
Being tested
Licensed 2010-2011 Trivalent Influenza Vaccine, No Preservative, Investigational Trivalent Influenza Vaccine with alternate B strain, No Preservative, Quadrivalent Influenza Vaccine, No Preservative
Keywords
Influenza, Quadrivalent Influenza Vaccine, Trivalent Influenza Vaccine, Influenza viruses, Fluzone®
Medical subject headings
Influenza, Human

What participants receive

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

  • Licensed 2010-2011 Trivalent Influenza Vaccine, No PreservativeBiological

    Also called Fluzone®

    0.25 mL (6 to 35 months) or 0.5 mL (3 to <9 years), Intramuscular

  • Investigational Trivalent Influenza Vaccine with alternate B strain, No PreservativeBiological

    0.25 mL (6 to 35 months) or 0.5 mL (3 to <9 years), Intramuscular

  • Quadrivalent Influenza Vaccine, No PreservativeBiological

    0.25 mL (6 to 35 months), or 0.5 mL(3 to <9 years), Intramuscular

Study groups in NCT01240746
Study groupRoleWhat they receive
Group 1: Licensed 2010-2011 TIVActive comparatorParticipants will receive the Licensed 2010-2011 Trivalent Influenza Vaccine containing the primary B strain.
Receives: Biological: Licensed 2010-2011 Trivalent Influenza Vaccine, No Preservative
Group 2: Investigational TIVExperimentalParticipants will receive the Investigational Trivalent Influenza Vaccine containing the alternate B strain
Receives: Biological: Investigational Trivalent Influenza Vaccine with alternate B strain, No Preservative
Group 3: Investigational QIVExperimentalParticipants will receive the investigational Quadrivalent Influenza Vaccine
Receives: Biological: Quadrivalent Influenza Vaccine, No Preservative

What is being measured

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

  1. Geometric Mean Titers Against Influenza A Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants

    Immunogenicity outcomes were assessed in serum samples by hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.

    Measured: Day 28 post final vaccination

  2. Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines With Corresponding B Strain in All Participants

    Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.

    Measured: Day 28 post final vaccination

  3. Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines Without Corresponding B Strain in All Participants

    Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.

    Measured: Day 28 post final vaccination

  4. Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months.

    Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.

    Measured: Day 28 post final vaccination

  5. Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years.

    Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.

    Measured: Day 28 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 posted15 Nov 2010 (estimated)
  2. Study startNov 2010
  3. Primary completionDec 2011
  4. Study completionFeb 2012

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
4,363 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01240746
Sponsor's protocol ID
QIV04
Other IDs
UTN: U1111-1114-3713
Status last verified
Jun 2015
First submitted
11 Nov 2010
Last updated
14 Jul 2015
Data monitoring committee
No

Publications

  • Greenberg DP, Robertson CA, Landolfi VA, Bhaumik A, Senders SD, Decker MD. Safety and immunogenicity of an inactivated quadrivalent influenza vaccine in children 6 months through 8 years of age. Pediatr Infect Dis J. 2014 Jun;33(6):630-6. doi: 10.1097/INF.0000000000000254.

    PubMed 24445833

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Licensed 2010-2011 Trivalent Influenza Vaccine, No Preservative, Investigational Trivalent Influenza Vaccine with alternate B strain, No Preservative and Quadrivalent Influenza Vaccine, No Preservative in people with Influenza, run by Sanofi Pasteur, a Sanofi Company at 67 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 5 inclusion and 15 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 14 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 67 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 14 Jan 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 Influenza A Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants (time frame: Day 28 post final vaccination). The study lists 5 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 NCT01240746, 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 14 Jul 2015.

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