InfluenzaPhase 3NCT00885105

Evaluation of Responses to Fluzone® in Infants ≥ 6 Months of Age Who Did or Did Not Receive Fluzone® at 2 Months of Age

A Phase 3 study testing Influenza Virus Vaccine in people with Influenza, run by Sanofi Pasteur, a Sanofi Company at 6 sites in United States.

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 study is to compare the 2 Groups with respect to antibody responses to inactivated influenza vaccine. Observational Objectives: To describe the percentage of participants with protective Hemagglutinin (HAI) antibody titers to each of the 3 vaccine antigens in both study groups following each vaccination. Read more about this study

Who is it for?: Ages 6 to 11 monthsHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: Influenza Virus Vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 242 participants
Where: 6 sitesUnited States
Study dates: Oct 2005to Sep 2007
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 to 11 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Participant is between 6 and 10 months of age on the day of inclusion (has reached 6-month but has not reached 11-month anniversary of birth).
Available for the duration of the study.
Born at full term of pregnancy (≥ 36 weeks) with a birth weight ≥ 2.5 kg
Parent/legal acceptable representative willing and able to provide informed consent.
Parent/legal acceptable representative able to attend all scheduled visits and comply with all trial procedures.
Parent/legal acceptable representative willing to permit venipuncture for purposes of collecting a blood sample.
Previously enrolled in the 2-month-old group in Study GRC27 or approved by sponsor for enrollment as control.

Who cannot join

Reported allergy to egg proteins, chicken proteins, or any other constituent of Fluzone vacccine.
Previous history of influenza vaccination (Group 2 subjects only).
Receipt of any vaccine in the 14 days prior to enrollment.
An acute illness with or without fever (rectal temperature ≥ 38.0 °C [or ≥100.4 °F]) in the 72 hours preceding enrollment in the trial.
Known bleeding disorder.
Participation in any other interventional (e.g., vaccine, drug) clinical trial (except Study GRC27) within 30 days prior to enrollment, or planned participation in another interventional clinical trial prior to termination of the subject's participation in this study.

Show all 15Show fewer

Known or suspected impairment of immunologic function or receipt of immunosuppressive therapy or immunoglobulin since birth.
Personal or immediate family history of congenital immune deficiency.
Developmental delay, neurologic disorder, or seizure disorder.
Chronic medical, congenital or developmental disorder that could interfere with trial conduct or completion.
Known human immunodeficiency virus (HIV)-positive or hepatitis B surface antigen (HBsAg)-positive mother.
Known HIV, hepatitis B, or hepatitis C infection.
Receipt of blood or blood-derived products within the past 2 months.
Prior history of Guillain-Barré syndrome.
Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Study site
Dayton, Ohio, 45404
Study site
Durham, North Carolina, 27704
Study site
Little Rock, Arkansas, 72205
Study site
Marietta, Georgia, 30062
Study site
Pittsburgh, Pennsylvania, 15241
Study site
Seattle, Washington, 98040

Other trials in United States

About this study

Official title: Evaluation of Serologic Responses to Fluzone® in Infants ≥ 6 Months of Age Who Did or Did Not Receive Fluzone® Vaccine at 2 Months of Age

The study is to compare the 2 Groups with respect to antibody responses to inactivated influenza vaccine.

Observational Objectives:

To describe the percentage of participants with protective Hemagglutinin (HAI) antibody titers to each of the 3 vaccine antigens in both study groups following each vaccination.
To describe the HAI geometric mean titer (GMTs) to each of the 3 vaccine antigens in both study groups following each vaccination.
To describe the safety of the 2005-2006 pediatric formulation of Fluzone® vaccine in both study groups.

Read the detailed description

This is a descriptive study that will provide preliminary comparative information about the safety and immunogenicity of Fluzone® vaccine among children who were given Fluzone® vaccine at 2 months of age (Study GRC27 NCT00858468)and those who never received influenza vaccine.

Conditions: Influenza
Being tested: Influenza Virus Vaccine
Keywords: Fluzone® vaccine, Influenza
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 VaccineBiological
Also called Fluzone® 2005-2006 Pediatric Formulation
0.25 mL, Intramuscular
Influenza Virus VaccineBiological
Also called Fluzone® 2005-2006 Pediatric Formulation
0.25 mL, Intramuscular

Study groups in NCT00885105
Study group	Role	What they receive
Fluzone® Vaccine-Primed Group	Experimental	Participants received 2 doses of Fluzone® vaccine at 2 months (in Study GRC 27) Receives: Biological: Influenza Virus Vaccine
Influenza Vaccine-Naive Group	Active comparator	Participants who have never received influenza vaccine (and not in Study GRC27) Receives: Biological: Influenza Virus Vaccine

What is being measured

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

Summary of Influenza Seroprotection Post-vaccination With Fluzone® Vaccine.
Seroprotection was defined as a Reciprocal Hemagglutination Inhibition Titers of ≥ 40 Post-vaccination with Fluzone® Vaccine.
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.

Oct 2005Sep 2007

First posted21 Apr 2009 (estimated)
Study startOct 2005
Primary completionJan 2006
Study completionSep 2007

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 3
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 242 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00885105
Sponsor's protocol ID: GRC32
Status last verified: Apr 2016
First submitted: 20 Apr 2009
Last updated: 14 Apr 2016
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

Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza

All Influenza trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Serologic Responses to Fluzone® in Infants ≥ 6 Months of Age Who Did or Did Not Receive Fluzone® Vaccine at 2 Months of Age
ClinicalTrials.gov ID: NCT00885105
Acronym / sponsor ID: GRC32
Conditions: Influenza
Keywords: Fluzone® vaccine, Influenza
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 242 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: Oct 2005
Primary completion: Jan 2006 (actual)
Study completion: Sep 2007 (actual)
First posted: 21 Apr 2009 (estimated)
Results: Posted 1 Jan 2010

Clinical summary

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

The study is to compare the 2 Groups with respect to antibody responses to inactivated influenza vaccine.

Observational Objectives:

To describe the percentage of participants with protective Hemagglutinin (HAI) antibody titers to each of the 3 vaccine antigens in both study groups following each vaccination.
To describe the HAI geometric mean titer (GMTs) to each of the 3 vaccine antigens in both study groups following each vaccination.
To describe the safety of the 2005-2006 pediatric formulation of Fluzone® vaccine in both study groups.

Detailed description

Study design

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

Arm	Type	Receives
Fluzone® Vaccine-Primed Group	Experimental	Biological: Influenza Virus VaccineParticipants received 2 doses of Fluzone® vaccine at 2 months (in Study GRC 27)
Influenza Vaccine-Naive Group	Active comparator	Biological: Influenza Virus VaccineParticipants who have never received influenza vaccine (and not in Study GRC27)

Who may qualify

Ages: 6 to 11 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (7 listed)

Participant is between 6 and 10 months of age on the day of inclusion (has reached 6-month but has not reached 11-month anniversary of birth).
Available for the duration of the study.
Born at full term of pregnancy (≥ 36 weeks) with a birth weight ≥ 2.5 kg
Parent/legal acceptable representative willing and able to provide informed consent.
Parent/legal acceptable representative able to attend all scheduled visits and comply with all trial procedures.

Key exclusion criteria (15 listed)

Reported allergy to egg proteins, chicken proteins, or any other constituent of Fluzone vacccine.
Previous history of influenza vaccination (Group 2 subjects only).
Receipt of any vaccine in the 14 days prior to enrollment.
An acute illness with or without fever (rectal temperature ≥ 38.0 °C [or ≥100.4 °F]) in the 72 hours preceding enrollment in the trial.
Known bleeding disorder.

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
Influenza Virus VaccineAlso: Fluzone® 2005-2006 Pediatric Formulation0.25 mL, Intramuscular	Biological	Fluzone® Vaccine-Primed Group
Influenza Virus VaccineAlso: Fluzone® 2005-2006 Pediatric Formulation0.25 mL, Intramuscular	Biological	Influenza Vaccine-Naive Group

Primary outcome

Summary of Influenza Seroprotection Post-vaccination With Fluzone® Vaccine.
Time frame: Day 28 Post-vaccination
Seroprotection was defined as a Reciprocal Hemagglutination Inhibition Titers of ≥ 40 Post-vaccination with Fluzone® Vaccine.

Results and safety

Results posted to the registry on 1 Jan 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fluzone® Vaccine-Primed Group	112	111
Influenza Vaccine-Naive Group	130	120

Primary outcome: Summary of Influenza Seroprotection Post-vaccination With Fluzone® Vaccine.

Time frame: Day 28 Post-vaccination. Number. Unit: Percentage of Participants

Measure	Fluzone® Vaccine-Primed Group n = 51	Influenza Vaccine-Naive Group n = 51
A/New Caledonia/20/99 Post-Dose 1	44	34
A/New York/55/2004 Post-Dose 1	31	74
B/Jiangsu/310/2003 Post-Dose 1	22	6
A/New Caledonia/20/99 Post-Dose 2	69	86
A/New York/55/2004 Post-Dose 2	84	100
B/Jiangsu/310/2003 Post-Dose 2	28	47

Population analysed: Hemagglutination inhibition titers to the Influenza vaccine antigens were assessed in the per-protocol immunogenicity population.

Adverse events

Time frame: Adverse event data were collected over a period of 8 months. Six months post-vaccination 2. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fluzone® Vaccine-Primed Group	5 of 112 (4.5%)	57 of 112 (50.9%)	Not reported
Influenza Vaccine-Naive Group	1 of 130 (0.8%)	56 of 130 (43.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Influenza

Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza

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 Monitor study director

Sanofi Pasteur Inc.

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Influenza Virus Vaccine in people with Influenza, run by Sanofi Pasteur, a Sanofi Company at 6 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 7 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 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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 1 Jan 2010). 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?

Summary of Influenza Seroprotection Post-vaccination With Fluzone® Vaccine. (time frame: Day 28 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 NCT00885105.

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 Apr 2016.