InfluenzaPhase 2NCT00623181

Study to Determine a Preference for Fluzone Vaccine Given Intradermally (ID) and Intramuscularly (IM) in Healthy Adults

A Phase 2 study testing Fluzone: Influenza virus vaccine 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

Search all trials

Trial summary

To describe any degree of preference for the route of administration of Fluzone influenza vaccine, ID versus IM, in healthy adult subjects 18-49 years of age. To collect safety data, injection site reactions, and systemic reactions, through Day 7 post-vaccination; SAEs through day 28 post-vaccination Read more about this study

Who is it for?: Ages 18 to 49 yearsHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: Fluzone: Influenza virus vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 110 participants
Where: 2 sitesUnited States
Study dates: Jan 2008to Jun 2008
Phase: Phase 2
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 49 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male or female subject (can have underlying medical condition, as long as they are stable), greater than or equal to 18 to < 50 years of age on the day of inclusion.
Informed consent form signed.
Able to attend both scheduled visits and to comply with all trial procedures.
For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to vaccination, until at least 4 weeks after vaccination.

Who cannot join

Subject currently breast-feeding.
Participation in another investigational clinical trial in the 4 weeks preceding and during the trial period.
Hypersensitivity to egg proteins, chicken proteins, or to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing any of the same substances.
Thrombocytopenia or bleeding disorder contraindicating IM vaccination.
Any other condition which in the opinion of the Investigator would pose a health risk to the subject or interfere with the evaluation of the vaccine.
Personal history of Guillain-Barre syndrome.

Show all 9Show fewer

Current use of alcohol or recreational drugs that in the opinion of the Investigator might interfere with the subject's ability to comply with trial procedures.
Febrile illness (oral temperature greater than or equal to 99.5 degrees F) on day of inclusion (temporary deferral).
Influenza vaccination received this season (2007-2008).

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Study site
Grove City, Pennsylvania, 16127
Study site
Pittsburgh, Pennsylvania, 15241

Other trials in United States

About this study

Official title: Preference for Fluzone Vaccine Administered Intradermally Versus Intramuscularly in Healthy Adult Subjects 18-49 Years of Age

To describe any degree of preference for the route of administration of Fluzone influenza vaccine, ID versus IM, in healthy adult subjects 18-49 years of age.

To collect safety data, injection site reactions, and systemic reactions, through Day 7 post-vaccination; SAEs through day 28 post-vaccination

Read the detailed description

The purpose of this clinical trial is to determine, in a relatively small sample of persons 18-49 years of age, if there is a preference trend for a particular route of administration, ID vs IM, when receiving a seasonal influenza vaccine. Uptake of influenza vaccine is disappointingly low in this age group, and there is the perception that aversion to IM injection plays a role in vaccination avoidance. The BD Micro-Injection System to be used in this study may offer a more acceptable alternative to the standard IM injection for influenza immunization and thereby promote wider acceptance of influenza vaccination.

Conditions: Influenza
Being tested: Fluzone: Influenza virus vaccine
Keywords: Influenza, Influenza virus
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 vaccineBiological
Also called Fluzone®
0.1 mL, Intradermal Right deltoid, 0.5 mL, Intramuscular Left deltoid
Fluzone: Influenza virus vaccineBiological
Also called Fluzone®
0.5 mL, Intramuscular Right deltoid, 0.1 mL, Intradermal Left deltoid

Study groups in NCT00623181
Study group	Role	What they receive
Fluzone Intradermal First, Then Fluzone Intramuscular	Experimental	Not described Receives: Biological: Fluzone: Influenza virus vaccine
Fluzone Intramuscular First, Then Fluzone Intradermal	Experimental	Not described Receives: Biological: Fluzone: Influenza virus vaccine

What is being measured

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

Categorical Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination
Pain or other discomfort was assessed on a scale of 0 to 10 (None = 0; Hardly Any = 1, 2; Mild = 3, 4; Moderate = 5, 6; Severe = 7, 8; Unbearable = 9, 10) according to route of administration: intradermal (ID) as Group 1 and intramuscular (IM) as Group 2.
Data for this outcome were combined for responses following a similar type of vaccination route in the entire study population.
Measured: Day 0 and up to 7 days post-vaccination
Continuous Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination
Numerical scores were assigned to pain by participants on the preference questionnaire as: None = 0; Hardly Any = 1, 2; Mild = 3, 4; Moderate = 5, 6; Severe = 7, 8; or Unbearable = 9, 10.
Data for this outcome were combined for responses following a similar type of vaccination route in the entire study population.
Measured: Days 0, 3, and 7 after vaccination

Timeline

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

Jan 2008Jun 2008

First posted25 Feb 2008 (estimated)
Study startJan 2008
Primary completionMay 2008
Study completionJun 2008

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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 110 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00623181
Sponsor's protocol ID: FID30
Status last verified: Apr 2016
First submitted: 6 Feb 2008
Last updated: 14 Apr 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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 invitationObservational study
Long-term Observation of Hemagglutinin and Neuraminidase Inhibition Antibody Titers After Influenza Challenge
Post Influenza
RecruitingObservational study
Screening for LID Clinical Studies Unit Healthy Volunteer Protocols
Zika, Influenza
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Active, not recruitingObservational study
A Study to Look at the Health Outcomes of Patients With COVID-19 and Influenza
COVID-19, Coronavirus Disease 2019
RecruitingPhase 1
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Children
Seasonal 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: Preference for Fluzone Vaccine Administered Intradermally Versus Intramuscularly in Healthy Adult Subjects 18-49 Years of Age
ClinicalTrials.gov ID: NCT00623181
Acronym / sponsor ID: FID30
Conditions: Influenza
Keywords: Influenza, Influenza virus
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 110 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: Jan 2008
Primary completion: May 2008 (actual)
Study completion: Jun 2008 (actual)
First posted: 25 Feb 2008 (estimated)
Results: Posted 11 Aug 2011

Clinical summary

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

To describe any degree of preference for the route of administration of Fluzone influenza vaccine, ID versus IM, in healthy adult subjects 18-49 years of age.

To collect safety data, injection site reactions, and systemic reactions, through Day 7 post-vaccination; SAEs through day 28 post-vaccination

Detailed description

Study design

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

Arm	Type	Receives
Fluzone Intradermal First, Then Fluzone Intramuscular	Experimental	Biological: Fluzone: Influenza virus vaccine
Fluzone Intramuscular First, Then Fluzone Intradermal	Experimental	Biological: Fluzone: Influenza virus vaccine

Who may qualify

Ages: 18 to 49 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Healthy male or female subject (can have underlying medical condition, as long as they are stable), greater than or equal to 18 to < 50 years of age on the day of inclusion.
Informed consent form signed.
Able to attend both scheduled visits and to comply with all trial procedures.
For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to vaccination, until at least 4 weeks after vaccination.

Key exclusion criteria (9 listed)

Subject currently breast-feeding.
Participation in another investigational clinical trial in the 4 weeks preceding and during the trial period.
Hypersensitivity to egg proteins, chicken proteins, or to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing any of the same substances.
Thrombocytopenia or bleeding disorder contraindicating IM vaccination.
Any other condition which in the opinion of the Investigator would pose a health risk to the subject or interfere with the evaluation of the 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 vaccineAlso: Fluzone®0.1 mL, Intradermal Right deltoid, 0.5 mL, Intramuscular Left deltoid	Biological	Fluzone Intradermal First, Then Fluzone Intramuscular
Fluzone: Influenza virus vaccineAlso: Fluzone®0.5 mL, Intramuscular Right deltoid, 0.1 mL, Intradermal Left deltoid	Biological	Fluzone Intramuscular First, Then Fluzone Intradermal

Primary outcome

Categorical Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination
Time frame: Day 0 and up to 7 days post-vaccination
Pain or other discomfort was assessed on a scale of 0 to 10 (None = 0; Hardly Any = 1, 2; Mild = 3, 4; Moderate = 5, 6; Severe = 7, 8; Unbearable = 9, 10) according to route of administration: intradermal (ID) as Group 1 and intramuscular (IM) as Group 2. Data for this outcome were combined for responses following a similar type of vaccination route in the entire study population.
Continuous Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination
Time frame: Days 0, 3, and 7 after vaccination
Numerical scores were assigned to pain by participants on the preference questionnaire as: None = 0; Hardly Any = 1, 2; Mild = 3, 4; Moderate = 5, 6; Severe = 7, 8; or Unbearable = 9, 10. Data for this outcome were combined for responses following a similar type of vaccination route in the entire study population.

Results and safety

Results posted to the registry on 11 Aug 2011, 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 Intradermal First, Then Fluzone Intramuscular	56	56
Fluzone Intramuscular First, Then Fluzone Intradermal	54	54

Primary outcome: Categorical Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination

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

Measure	Fluzone Intradermal Vaccine n = 101	Fluzone Intramuscular Vaccine n = 101
Any - Day 0	85	75
Severe or Worse - Day 0	4	2
Any - Day 3	44	35
Severe or Worse - Day 3	0	0
Any - Day 7	5	4
Severe or Worse - Day 7	0	0

Population analysed: Pain or other discomfort was assessed in the Per-Protocol Population. Data were combined for responses following a similar type of vaccination route.

Primary outcome: Continuous Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination

Time frame: Days 0, 3, and 7 after vaccination. Mean (Standard Deviation). Unit: Scores on a scale

Measure	Fluzone Intradermal Vaccine n = 101	Fluzone Intramuscular Vaccine n = 101
Day 0	2.97 (2.13)	2.02 (1.90)
Day 3	0.79 (1.23)	0.68 (1.20)
Day 7	0.08 (0.39)	0.05 (0.26)

Adverse events

Time frame: Adverse event data were collected from the day of vaccination for up to 28 days post-vaccination.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fluzone Intradermal First, Then Fluzone Intramuscular	0 of 56 (0%)	92 of 110 (83.6%)	Not reported
Fluzone Intramuscular First, Then Fluzone Intradermal	0 of 54 (0%)	75 of 110 (68.2%)	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 invitationObservational study
Long-term Observation of Hemagglutinin and Neuraminidase Inhibition Antibody Titers After Influenza Challenge
Post Influenza
RecruitingObservational study
Screening for LID Clinical Studies Unit Healthy Volunteer Protocols
Zika, Influenza
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Active, not recruitingObservational study
A Study to Look at the Health Outcomes of Patients With COVID-19 and Influenza
COVID-19, Coronavirus Disease 2019
RecruitingPhase 1
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Children
Seasonal 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

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fluzone: Influenza virus vaccine in people with Influenza, run by Sanofi Pasteur, a Sanofi Company at 2 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 4 inclusion and 9 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 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 11 Aug 2011). 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?

Categorical Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination (time frame: Day 0 and up to 7 days 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 NCT00623181.

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.