AzTrials
AzTrials

InfluenzaPhase 4NCT02915302

Safety and Immunogenicity of Fluzone® Quadrivalent Vaccine Administered to Healthy Children

A Phase 4 study testing Fluzone Quadrivalent vaccine, No Preservative in people with Influenza, run by Sanofi Pasteur, a Sanofi Company at 36 sites in 2 countries.

Completed

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

Official record
Search all trials

Trial summary

The aim of the study was to describe the safety and immunogenicity of a 0.5-mL dose (15 μg hemagglutinin [HA] per strain) of Fluzone Quadrivalent vaccine in children 6 to <36 months of age. Read more about this study

Who is it for?
Ages 6 to 35 monthsHealthy volunteers can take part
Conditions the study is for
Influenza
What is being tested?
Fluzone Quadrivalent vaccine, No Preservative
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,950 participants
Where
36 sitesin 2 countries
Study dates
23 Sep 2016to 6 Mar 2017
Phase
Phase 4
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 to 35 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Aged 6 to < 36 months of age on the day of first study vaccination (study product administration).
  • Born at full term of pregnancy (≥37 weeks) and/or with a birth weight ≥2.5 kg. Note: This inclusion criterion only applies to participants 6 to <12 months of age on the day of the first study visit.
  • Informed consent form has been signed and dated by the parent(s) or guardian(s).
  • Participant and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures.

Who cannot join

  • Participation at the time of study enrollment (or in the 30 days preceding the first 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 30 days preceding the first trial vaccination, or planned receipt of any vaccine before Visit 2 for participants receiving 1 dose of influenza vaccine or Visit 3 for participants receiving 2 doses of influenza vaccine.
  • Previous vaccination against influenza (in the 2016-2017 season) with either the trial vaccine or another vaccine.
  • 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.
Show all 17Show fewer
  • Thrombocytopenia, which may be a contraindication for intramuscular vaccination, at the discretion of the Investigator.
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination.
  • Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
  • Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion.
  • Moderate or severe acute illness/infection (according to Investigator judgment) on the day of planned vaccination or febrile illness (temperature ≥100.4 degrees Fahrenheit [38.0 degrees Celsius]). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
  • Identified as a natural or adopted child of either the Investigator or an employee with direct involvement in the proposed study.
  • History of serious adverse reactions to any influenza vaccine.
  • Personal history of Guillain-Barré syndrome.
  • Any condition that in the opinion of the Investigator would pose a health risk to the participant if enrolled or could interfere with the evaluation of the vaccine.
  • Personal history of clinically significant developmental delay (at the discretion of the Investigator), neurologic disorder, or seizure disorder.
  • Known seropositivity for human immunodeficiency virus, hepatitis B, or hepatitis C.

Trial locations and contacts

36 sites in 2 countries.

36 sites in 2 countries

United States35 sites

  • Study site

    Bardstown, Kentucky, 40004

  • Study site

    Birmingham, Alabama, 35205

  • Study site

    Burke, Virginia, 22015

  • Study site

    Charleston, South Carolina, 29407

  • Study site

    Charleston, South Carolina, 29414

  • Study site

    Dayton, Ohio, 45414

  • Study site

    Downey, California, 90241

  • Study site

    Erie, Pennsylvania, 16505

  • Study site

    Fort Worth, Texas, 76107

  • Study site

    Gresham, Oregon, 97030

  • Study site

    Grove City, Ohio, 43123

  • Study site

    Harrisburg, Arkansas, 72432

  • Study site

    Houston, Texas, 77055

  • Study site

    Layton, Utah, 84041

  • Study site

    Lincoln, Nebraska, 68504

  • Study site

    Lincoln, Nebraska, 68505

  • Study site

    Lincoln, Nebraska, 68516

  • Study site

    Meridian, Idaho, 83642

  • Study site

    Metairie, Louisiana, 70006

  • Study site

    Miami, Florida, 33142

  • Study site

    Miami Beach, Florida, 33140

  • Study site

    Norfolk, Nebraska, 68701

  • Study site

    Omaha, Nebraska, 68131

  • Study site

    Omaha, Nebraska, 68134

  • Study site

    Orem, Utah, 84057

  • Study site

    Paramount, California, 90723

  • Study site

    Provo, Utah, 84604

  • Study site

    Roy, Utah, 84067

  • Study site

    Sacramento, California, 95815

  • Study site

    San Diego, California, 92111

  • Study site

    South Jordan, Utah, 84095

  • Study site

    Syracuse, New York, 13057

  • Study site

    Thornton, Colorado, 80233

  • Study site

    Tullahoma, Tennessee, 37388

  • Study site

    West Jordan, Utah, 84088

Other trials in United States

United Kingdom1 site

  • Study site

    Anaheim, California, 92804

Other trials in United Kingdom

About this study

Official title: Safety and Immunogenicity of Fluzone® Quadrivalent Vaccine Administered to Healthy Children 6 to < 36 Months of Age

The aim of the study was to describe the safety and immunogenicity of a 0.5-mL dose (15 μg hemagglutinin [HA] per strain) of Fluzone Quadrivalent vaccine in children 6 to <36 months of age.

Primary objective:

Read more
  • To compare the rate of any fever (temperature ≥100.4 degrees Fahrenheit [38.0 degrees Celsius) following a 0.5-mL dose of Fluzone Quadrivalent vaccine to that following a 0.25-mL dose of Fluzone Quadrivalent vaccine during the 7 days after either vaccination (Dose 1 and Dose 2 combined) in participants 6 to < 36 months of age.

Secondary objective:

  • To compare antibody responses induced by a 0.5-mL dose of Fluzone Quadrivalent vaccine to those induced by a 0.25-mL dose of Fluzone Quadrivalent vaccine as assessed by geometric mean titer (GMT) ratios and seroconversion rate differences after the final vaccination in participants 6 to < 36 months of age.

Other objectives:

  • To describe the safety of 2 different dose levels of the 2016-2017 formulation of Fluzone Quadrivalent vaccine in participants 6 to < 36 months of age.
  • To describe the immunogenicity of 2 different dose levels of the 2016-2017 formulation of Fluzone Quadrivalent vaccine in participants 6 months to < 36 months of age.
  • To submit available sera from approximately 30 participants to the Center for Biologics Evaluation and Research for further analysis by the World Health Organization, the Centers for Disease Control and Prevention, and the FDA to support formulation recommendations for subsequent influenza vaccines.
Read the detailed description

All participants received 1 intramuscular dose of Fluzone Quadrivalent vaccine during Visit 1. For participants, for whom 2 doses of influenza vaccine were recommended per Advisory Committee on Immunization Practices (ACIP) guidance, a second dose of Fluzone Quadrivalent vaccine (of the same volume as the first dose) was administered during Visit 2 (28 days after Visit 1).

Solicited adverse event (AE) information was collected for 7 days after each vaccination, unsolicited AE information was collected from Visit 1 to Visit 2 or to Visit 3 for participants receiving 2 doses of study vaccine. Serious adverse event (SAE) information was collected for 28 days after each vaccination.

Immunogenicity was evaluated in a planned subset of 1600 randomly selected participants prior to vaccination on Day 0 (Visit 1) and at Day 28 after the final vaccination.

Conditions
Influenza
Being tested
Fluzone Quadrivalent vaccine, No Preservative
Keywords
Influenza, Influenza virus vaccine, Fluzone® Quadrivalent Influenza Vaccine (No Preservative)
Medical subject headings
Influenza, Human

What participants receive

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

  • Fluzone Quadrivalent vaccine, No PreservativeBiological

    Also called Fluzone® Quadrivalent Influenza Vaccine

    0.25-mL (Pediatric Dose), Intramuscular (2016-2017 formulation)

  • Fluzone Quadrivalent vaccine, No PreservativeBiological

    Also called Fluzone® Quadrivalent Influenza Vaccine

    0.5-mL, Intramuscular (2016-2017 formulation)

Study groups in NCT02915302
Study groupRoleWhat they receive
Fluzone Quadrivalent Vaccine, 0.25-mLActive comparatorParticipants received a 0.25-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second 0.25-mL dose of Fluzone Quadrivalent vaccine was administered at Day 28.
Receives: Biological: Fluzone Quadrivalent vaccine, No Preservative
Fluzone Quadrivalent Vaccine, 0.5-mLExperimentalParticipants received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second 0.5-mL dose of Fluzone Quadrivalent vaccine was administered at Day 28.
Receives: Biological: Fluzone Quadrivalent vaccine, No Preservative

What is being measured

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

  1. Percentage of Participants With Fever (Fever Rate) Following Vaccination With Fluzone Quadrivalent Vaccine

    Fever rate was defined as percentage of participants with fever (temperature >=100.4 degrees Fahrenheit [38.0 degrees Celsius]) following vaccination with Fluzone Quadrivalent vaccine.

    Measured: Within 7 days after any vaccination

Secondary outcomes (2)

  1. Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies

    Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, B Yamagata lineage.

    Measured: 28 days post-final vaccination

  2. Percentage of Participants With Seroconversion (Seroconversion Rate [SCR]) to Influenza Vaccine Antigens

    Anti-influenza antibodies were measured using HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, B Yamagata lineage. SCR was defined as percentage of participants with either a pre-vaccination titer <10 (1/dil) and a post-final vaccination titer >=40 (1/dil), or a pre-vaccination titer >=10 (1/dil) and at least a four-fold increase in post-final vaccination titer.

    Measured: 28 days post-final vaccination

Timeline

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

  1. First posted27 Sep 2016 (estimated)
  2. Study start23 Sep 2016
  3. Primary completion6 Mar 2017
  4. Study completion6 Mar 2017

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
Single blind
Who is masked
Outcomes assessor
Enrolment
1,950 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02915302
Sponsor's protocol ID
GRC88
Other IDs
U1111-1143-9273
Status last verified
Mar 2022
First submitted
23 Sep 2016
Last updated
29 Mar 2022
Data monitoring committee
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Publications

  • Robertson CA, Mercer M, Selmani A, Klein NP, Jeanfreau R, Greenberg DP. Safety and Immunogenicity of a Full-dose, Split-virion, Inactivated, Quadrivalent Influenza Vaccine in Healthy Children 6-35 Months of Age: A Randomized Controlled Clinical Trial. Pediatr Infect Dis J. 2019 Mar;38(3):323-328. doi: 10.1097/INF.0000000000002227.

    PubMed 30395011

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Fluzone Quadrivalent vaccine, No Preservative in people with Influenza, run by Sanofi Pasteur, a Sanofi Company at 36 sites in 2 countries.

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 17 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 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in United States, United Kingdom. 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?

Yes. Results are posted in the registry (first posted 3 Apr 2018). 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?

Percentage of Participants With Fever (Fever Rate) Following Vaccination With Fluzone Quadrivalent Vaccine (time frame: Within 7 days after any vaccination). 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 NCT02915302, 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 29 Mar 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in