Immune ResponseNCT00902278
Immune Responses Induced by Different Licensed Influenza Vaccines
A study testing Flulaval, Fluvirin and Fluzone in people with Immune Response, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
The goal of this research is to find out how the body's immune system responds to different manufacturer's "flu" vaccines. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Immune Response
- What is being tested?
- Flulaval, Fluvirin and Fluzone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 193 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Apr 2016
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults (18-50 years of age)
- Willing to donate a blood sample multiple times
- Willing to sign informed consent and HIPAA
Who cannot join
- Known systemic hypersensitivity reactions to egg proteins (eggs or egg products), to chicken proteins
- Known hypersensitivity to neomycin, thimerosol (mercury derivative), neomycin, or polymyxin
- Previous life threatening reaction to influenza vaccine
- Individuals with altered immunocompetence state from medical condition ( HIV, cancer) or through immunosuppressive therapy(irradiation,corticosteroids, antimetabolites, alkylating agents, cytotoxic agents)
- Occurrence of neurological syndrome within six weeks of previous influenza immunization
- Active neurological disorder characterized by changing neurological disorder
Show all 9Show fewer
- Pregnancy
- Acute febrile illness
- History of anemia or bleeding disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Medical School
Worcester, Massachusetts, 01605
About this study
Official title: Immune Response Induced by Different Manufacturers of Influenza Vaccines
The goal of this research is to find out how the body's immune system responds to different manufacturer's "flu" vaccines.
Read the detailed description
There are currently five licensed inactivated influenza vaccines approved for use in the United States by the Food and Drug Administration.Current influenza virus vaccines consist of 3 components: the HA protein from an H1N1 virus, an H3N2 and an influenza B virus.Influenza vaccines are evaluated and approved by the FDA on the basis of HA and NA content. However, different manufacturing processes are involved in the preparation of these commercial vaccines and evidence suggests that each of these vaccines contain similar patterns of HA protein but different patterns of influenza influenza internal proteins such as NP and M1. The presence of these additional internal proteins of influenza virus which are targets of T cell responses suggest not only the potential for additional protection derived from influenza vaccines other than antibody mediated protection but also differential levels of T cell mediated protection between different manufacturers of commercial influenza vaccines.Each subject will have four blood samples taken- prevaccination and at Days 7, 14,30 and 3-5 months post vaccination. These samples will be tested for T and B cell responses and the results compared between different manufacturers.
- Conditions
- Immune Response
- Being tested
- Flulaval, Fluvirin, Fluzone, Fluarix, Afluria
- Keywords
- influenzavirus A, influenzavirus B, human influenza, T lymphocytes, influenza vaccines
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlulavalBiological
one 0.5-mL dose via intramuscular injection
FluvirinBiological
one 0.5-mL dose via intramuscular injection
FluzoneBiological
one 0.5-mL dose via intramuscular injection
FluarixBiological
one 0.5-mL dose via intramuscular injection
AfluriaBiological
one 0.5-mL dose via intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Flulaval | Active comparator | Not described Receives: Biological: Flulaval |
| Fluvirin | Active comparator | Not described Receives: Biological: Fluvirin |
| Fluzone | Active comparator | Not described Receives: Biological: Fluzone |
| Fluarix | Active comparator | Not described Receives: Biological: Fluarix |
| Affluria | Active comparator | Not described Receives: Biological: Afluria |
What is being measured
The primary outcome is the main question the study is designed to answer.
T Cell Responses Following Immunization
Comparison of mean peak fold increases in ELISPOT H1N1, H3N2, and B responses between different vaccine groups
Measured: Prevaccination and approximately 7 days,14 days ,1month and up to 3-5 months post vaccination
Secondary outcomes (1)
Antibody Responses Following Immunization
Geometric mean fold rise in antibody titer between day 0 ( baseline) and approximately 1 month post vaccination within each vaccine group
Measured: Prevaccination and approximately 1 month post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2009 (estimated)
- Study startOct 2008
- Primary completionApr 2016
- Study completionApr 2016
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 Immune ResponseStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Co, University of Massachusetts, Worcester
- Investigators
- Mary Dawn T Co, MD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00902278
- Sponsor's protocol ID
- H 13000
- Status last verified
- Jun 2017
- First submitted
- 13 May 2009
- Last updated
- 20 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Response Induced by Different Manufacturers of Influenza Vaccines
- ClinicalTrials.gov ID
- NCT00902278
- Acronym / sponsor ID
- H 13000
- Conditions
- Immune Response
- Keywords
- influenzavirus A, influenzavirus B, human influenza, T lymphocytes, influenza vaccines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 15 May 2009 (estimated)
- Results
- Posted 20 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this research is to find out how the body's immune system responds to different manufacturer's "flu" vaccines.
Detailed description
There are currently five licensed inactivated influenza vaccines approved for use in the United States by the Food and Drug Administration.Current influenza virus vaccines consist of 3 components: the HA protein from an H1N1 virus, an H3N2 and an influenza B virus.Influenza vaccines are evaluated and approved by the FDA on the basis of HA and NA content. However, different manufacturing processes are involved in the preparation of these commercial vaccines and evidence suggests that each of these vaccines contain similar patterns of HA protein but different patterns of influenza influenza internal proteins such as NP and M1. The presence of these additional internal proteins of influenza virus which are targets of T cell responses suggest not only the potential for additional protection derived from influenza vaccines other than antibody mediated protection but also differential levels of T cell mediated protection between different manufacturers of commercial influenza vaccines.Each subject will have four blood samples taken- prevaccination and at Days 7, 14,30 and 3-5 months post vaccination. These samples will be tested for T and B cell responses and the results compared between different manufacturers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Flulaval | Active comparator | Biological: Flulaval |
| Fluvirin | Active comparator | Biological: Fluvirin |
| Fluzone | Active comparator | Biological: Fluzone |
| Fluarix | Active comparator | Biological: Fluarix |
| Affluria | Active comparator | Biological: Afluria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (18-50 years of age)
- Willing to donate a blood sample multiple times
- Willing to sign informed consent and HIPAA
Key exclusion criteria (9 listed)
- Known systemic hypersensitivity reactions to egg proteins (eggs or egg products), to chicken proteins
- Known hypersensitivity to neomycin, thimerosol (mercury derivative), neomycin, or polymyxin
- Previous life threatening reaction to influenza vaccine
- Individuals with altered immunocompetence state from medical condition ( HIV, cancer) or through immunosuppressive therapy(irradiation,corticosteroids, antimetabolites, alkylating agents, cytotoxic agents)
- Occurrence of neurological syndrome within six weeks of previous influenza immunization
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 |
|---|---|---|
| Flulavalone 0.5-mL dose via intramuscular injection | Biological | Flulaval |
| Fluvirinone 0.5-mL dose via intramuscular injection | Biological | Fluvirin |
| Fluzoneone 0.5-mL dose via intramuscular injection | Biological | Fluzone |
| Fluarixone 0.5-mL dose via intramuscular injection | Biological | Fluarix |
| Afluriaone 0.5-mL dose via intramuscular injection | Biological | Affluria |
Primary outcome
T Cell Responses Following Immunization
Time frame: Prevaccination and approximately 7 days,14 days ,1month and up to 3-5 months post vaccination
Comparison of mean peak fold increases in ELISPOT H1N1, H3N2, and B responses between different vaccine groups
1 secondary outcome
Antibody Responses Following Immunization
Time frame: Prevaccination and approximately 1 month post vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Mary Dawn T Co, MD principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flulaval, Fluvirin and Fluzone in people with Immune Response, run by University of Massachusetts, Worcester at 1 site 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 3 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 20 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Nov 2017). 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?
T Cell Responses Following Immunization (time frame: Prevaccination and approximately 7 days,14 days ,1month and up to 3-5 months post vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Nov 2017.