InfluenzaPhase 4NCT01691326

Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)

A Phase 4 study testing Fluzone®: Influenza Virus Vaccine, No Preservative: Pediatric Dose and Fluzone®; Influenza Virus Vaccine, No Preservative in people with Influenza, run by Sanofi Pasteur, a Sanofi Company at 2 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 this clinical study is to demonstrate safety and immunogenicity of Fluzone vaccine. Objective: To describe the safety of the 2012-2013 formulation of Fluzone vaccine, administered in a 1- or 2-dose schedule, in accordance with Advisory Committee on Immunization Practices (ACIP) recommendations, 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?: Fluzone®: Influenza Virus Vaccine, No Preservative: Pediatric Dose and Fluzone®; Influenza Virus Vaccine, No Preservative
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 2 sitesUnited States
Study dates: Sep 2012to Feb 2013
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 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
Assent form has been signed and dated by subjects 7 to < 9 years of age, and informed consent form has been signed and dated by parent(s) or another legally acceptable representative
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

Known systemic hypersensitivity to eggs, chicken proteins, latex, or any of the vaccine components, or a history of a life-threatening reaction to Fluzone vaccine or to a vaccine containing any of the same substances (the complete list of vaccine components is included in the Prescribing Information)
History of serious adverse reaction to any influenza vaccine
Receipt of any vaccine within 30 days before receiving study vaccine, or plans to receive another vaccine before Visit 2 for subjects receiving 1 influenza vaccine or Visit 3 for subjects receiving 2 doses of influenza vaccine
Participation in another interventional clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 30 days preceding the first study vaccination or during the course of the study unless no intervention for the other study occurred within the 30 days prior to the first study vaccination and none are planned before the subject would complete safety surveillance for the present study
Prior vaccination with any formulation of 2012-2013 influenza vaccine
Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, which may be a contraindication for intramuscular (IM) vaccination, at the discretion of the Investigator

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Thrombocytopenia, which may be a contraindication for IM vaccination, at the discretion of the Investigator
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 history of clinically significant developmental delay (at the discretion of the Investigator), neurologic disorder, or seizure disorder
Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
Known seropositivity for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 100.4°F). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
Receipt of immune globulins, blood, or blood-derived products in the past 3 months
Identified as a natural or adopted child of the Investigator or an employee with direct involvement in the proposed study.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Study site
Bardstown, Kentucky, 40004
Study site
Salt Lake City, Utah, 84124

Other trials in United States

About this study

The aim of this clinical study is to demonstrate safety and immunogenicity of Fluzone vaccine.

Objective:

To describe the safety of the 2012-2013 formulation of Fluzone vaccine, administered in a 1- or 2-dose schedule, in accordance with Advisory Committee on Immunization Practices (ACIP) recommendations, in children 6 months to < 9 years of age.

Observational Objectives:

To describe the immunogenicity of the 2012-2013 formulation of Fluzone vaccine, administered in a 1- or 2-dose schedule in accordance with ACIP recommendations, in children 6 months to < 9 years of age.
To submit remaining available sera from subjects to the Center for Biologics Evaluation and Research (CBER) for further analysis by the World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) to support selection and recommendation of strains for subsequent years' influenza vaccines.

Read the detailed description

All participants will receive Fluzone vaccine during Visit 1. For subjects receiving 2 doses of influenza vaccine, per ACIP guidance, a second dose of Fluzone vaccine will be administered during Visit 2.

Total duration of participation in the study is approximately 28 days for participants receiving 1 dose and 56 days for those receiving 2 doses of Fluzone vaccine.

Conditions: Influenza
Being tested: Fluzone®: Influenza Virus Vaccine, No Preservative: Pediatric Dose, Fluzone®; Influenza Virus Vaccine, No Preservative
Keywords: Influenza, Fluzone® (Influenza Virus Vaccine) 2012-2013 Formulation, Influenza virus vaccine, Trivalent Inactivated Influenza Vaccine
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®: Influenza Virus Vaccine, No Preservative: Pediatric DoseBiological
Also called Fluzone® (Influenza Virus Vaccine) 2012-2013 Formulation
0.25 mL dose, Intramuscular
Fluzone®; Influenza Virus Vaccine, No PreservativeBiological
Also called Fluzone® (Influenza Virus Vaccine) 2012 2013 Formulation
0.5 mL dose, Intramuscular

Study groups in NCT01691326
Study group	Role	What they receive
6 months to < 36 months of age group	Experimental	Participants at 6 months to < 36 months of age at the time of enrollment will receive Influenza Virus Vaccine, No Preservative; Fluzone® (Pediatric Dose). Receives: Biological: Fluzone®: Influenza Virus Vaccine, No Preservative: Pediatric Dose
3 years to < 9 years of age group	Experimental	Participants at 3 years to < 9 years of age at the time of enrollment will receive Influenza Virus Vaccine, No Preservative; Fluzone®. Receives: Biological: Fluzone®; Influenza Virus Vaccine, No Preservative

What is being measured

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

Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)
Solicited injection site reactions (Age 6 to < 24 Months): Tenderness, Erythema and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability.
Grade 3: Tenderness, Cries when injected limb is moved; Erythema and Swelling, ≥ 50 mm; Fever, >103.1°F; Vomiting, ≥6 episodes/24 hours; Abnormal crying, >3 hours; Drowsiness, Sleeping most of the time; Loss of appetite, Refuses ≥3 feeds/meals or most feeds/meals; Irritability, Inconsolable.
Solicited injection site reactions (Age 24 Months to < 9 Years): Pain, Erythema, and Swelling. Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia.
Grade 3: Pain, Incapacitating, unable to perform usual activities; Redness and Swelling, ≥ 50 mm; Fever: ≥102.1°F; Headache, Malaise, and Myalgia, Significant, prevents 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.

Sep 2012Feb 2013

First posted24 Sep 2012 (estimated)
Study startSep 2012
Primary completionDec 2012
Study completionFeb 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for InfluenzaStudies of the same condition, open and under way.
More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01691326
Sponsor's protocol ID: GRC49
Other IDs: U1111-1124-8218
Status last verified: Mar 2014
First submitted: 19 Sep 2012
Last updated: 16 Apr 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)
ClinicalTrials.gov ID: NCT01691326
Acronym / sponsor ID: GRC49
Conditions: Influenza
Keywords: Influenza, Fluzone® (Influenza Virus Vaccine) 2012-2013 Formulation, Influenza virus vaccine, Trivalent Inactivated Influenza Vaccine
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: Sep 2012
Primary completion: Dec 2012 (actual)
Study completion: Feb 2013 (actual)
First posted: 24 Sep 2012 (estimated)
Results: Posted 16 Apr 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The aim of this clinical study is to demonstrate safety and immunogenicity of Fluzone vaccine.

Objective:

To describe the safety of the 2012-2013 formulation of Fluzone vaccine, administered in a 1- or 2-dose schedule, in accordance with Advisory Committee on Immunization Practices (ACIP) recommendations, in children 6 months to < 9 years of age.

Observational Objectives:

To describe the immunogenicity of the 2012-2013 formulation of Fluzone vaccine, administered in a 1- or 2-dose schedule in accordance with ACIP recommendations, in children 6 months to < 9 years of age.
To submit remaining available sera from subjects to the Center for Biologics Evaluation and Research (CBER) for further analysis by the World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) to support selection and recommendation of strains for subsequent years' influenza vaccines.

Detailed description

Total duration of participation in the study is approximately 28 days for participants receiving 1 dose and 56 days for those receiving 2 doses of Fluzone vaccine.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
6 months to < 36 months of age group	Experimental	Biological: Fluzone®: Influenza Virus Vaccine, No Preservative: Pediatric DoseParticipants at 6 months to < 36 months of age at the time of enrollment will receive Influenza Virus Vaccine, No Preservative; Fluzone® (Pediatric Dose).
3 years to < 9 years of age group	Experimental	Biological: Fluzone®; Influenza Virus Vaccine, No PreservativeParticipants at 3 years to < 9 years of age at the time of enrollment will receive Influenza Virus Vaccine, No Preservative; Fluzone®.

Who may qualify

Ages: 6 months to 8 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

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
Assent form has been signed and dated by subjects 7 to < 9 years of age, and informed consent form has been signed and dated by parent(s) or another legally acceptable representative
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).

Key exclusion criteria (16 listed)

Known systemic hypersensitivity to eggs, chicken proteins, latex, or any of the vaccine components, or a history of a life-threatening reaction to Fluzone vaccine or to a vaccine containing any of the same substances (the complete list of vaccine components is included in the Prescribing Information)
History of serious adverse reaction to any influenza vaccine
Receipt of any vaccine within 30 days before receiving study vaccine, or plans to receive another vaccine before Visit 2 for subjects receiving 1 influenza vaccine or Visit 3 for subjects receiving 2 doses of influenza vaccine
Participation in another interventional clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 30 days preceding the first study vaccination or during the course of the study unless no intervention for the other study occurred within the 30 days prior to the first study vaccination and none are planned before the subject would complete safety surveillance for the present study
Prior vaccination with any formulation of 2012-2013 influenza vaccine

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fluzone®: Influenza Virus Vaccine, No Preservative: Pediatric DoseAlso: Fluzone® (Influenza Virus Vaccine) 2012-2013 Formulation0.25 mL dose, Intramuscular	Biological	6 months to < 36 months of age group
Fluzone®; Influenza Virus Vaccine, No PreservativeAlso: Fluzone® (Influenza Virus Vaccine) 2012 2013 Formulation0.5 mL dose, Intramuscular	Biological	3 years to < 9 years of age group

Primary outcome

Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)
Time frame: Day 0 up to Day 7 post-vaccination
Solicited injection site reactions (Age 6 to < 24 Months): Tenderness, Erythema and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability. Grade 3: Tenderness, Cries when injected limb is moved; Erythema and Swelling, ≥ 50 mm; Fever, >103.1°F; Vomiting, ≥6 episodes/24 hours; Abnormal crying, >3 hours; Drowsiness, Sleeping most of the time; Loss of appetite, Refuses ≥3 feeds/meals or most feeds/meals; Irritability, Inconsolable. Solicited injection site reactions (Age 24 Months to < 9 Years): Pain, Erythema, and Swelling. Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3: Pain, Incapacitating, unable to perform usual activities; Redness and Swelling, ≥ 50 mm; Fever: ≥102.1°F; Headache, Malaise, and Myalgia, Significant, prevents daily activity.

Results and safety

Results posted to the registry on 16 Apr 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Age 6 to < 36 Months Group	30	30
Age 3 to < 9 Years Group	30	30

Primary outcome: Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)

Time frame: Day 0 up to Day 7 post-vaccination. Number. Unit: Participants

Measure	Age 6 to < 36 Months Group n = 30	Age 3 to < 9 Years Group n = 30
Injection site Tenderness (N = 15, 0)	8	NA (0 to 0)
Grade 3 Injection site Tenderness (N =15, 0)	1	NA (0 to 0)
Injection site Pain (N =15, 30)	8	13 (0 to 0)
Grade 3 Injection site Pain (N = 15, 30)	0	0 (0 to 0)
Injection site Erythema (N = 30, 30)	8	9 (0 to 0)
Grade 3 Injection site Erythema (N = 30, 30)	0	0 (0 to 0)
Injection site Swelling (N = 30, 30)	5	7 (0 to 0)
Grade 3 Injection site Swelling (N = 30, 30)	0	0 (0 to 0)

Population analysed: Solicited injection site reactions and systemic reactions were assessed using the Safety Analysis Set, which includes all persons who received at least one dose of study vaccine.

Adverse events

Time frame: Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 after final vaccination.. Other adverse events reported at 5.00% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
6 to < 36 Months Age Group	0 of 30 (0%)	9 of 30 (30%)	Not reported
3 to < 9 Years Age Group	0 of 30 (0%)	13 of 30 (43.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Sanofi Pasteur Inc.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 16 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 16 Apr 2014. 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 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 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 16 Apr 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?

Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation) (time frame: Day 0 up to Day 7 post-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 NCT01691326.

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 16 Apr 2014.