InfluenzaNCT01023711
Immunologic Response to Inactivated Vaccine for Novel H1N1 Virus
A study testing Inactivated H1N1 vaccine in people with Influenza, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this study is to describe the immune response to a novel H1N1 influenza vaccination in healthy adults, and to understand the factors that allow healthy adults to respond to a single dose of vaccine even if they have never previously experience novel H1N1 disease or vaccination. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Inactivated H1N1 vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Jul 2011
- 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
- Aged 18-32 years, or 60 years and older
- No history of Novel H1N1 virus or vaccine
- Female not able to bear children or not pregnant and agrees to practice effective birth control
- Female negative pregnancy test
- Good Health
- Ability to understand and comply with protocol
- Provided Informed Consent
Who cannot join
- Previous history of vaccination against novel H1N1 or laboratory documented H1N1 infection
- Previous history of vaccination with A/New Jersey/76 vaccine (for subjects 60 \& older
- History of egg allergy or is allergic to other components of the vaccine
- Women who are pregnant or breastfeeding or intends to get pregnant during the study period between enrollment \& 30 days following vaccination
- Subject is immunosuppressed as the result of underlying illness or treatment with immunosuppressive or cytotoxic drugs or use of chemotherapy/radiation therapy in the preceding 36 months
- Subject has active neoplastic disease (excluding non-melanoma skin cancer or prostate cancer that is stable in the absence of therapy) or a history of any hematological malignancy. "Active" is defined as treatment within the past 5 years.
Show all 18Show fewer
- Long term (greater than 2 weeks) use of oral or parental steroids, or high- dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (nasal \& topical steroids allowed)
- Received immunoglobulin or other blood product within 3 months prior to enrollment in this study
- Subject has received an inactivated vaccine within 2 weeks or a live vaccine within 4 weeks prior to enrollment or plans to receive another vaccine within the next 28 days
- Subject has an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses. Those conditions include chronic conditions recognized as risk factors for influenza complications or as contraindicated for live vaccination, including chronic cardiac (exclusive of hypertension) or pulmonary conditions (including asthma), diabetes mellitus, or renal impairment
- Subject has an acute illness or an oral temperature greater then 99.9 F(37.7 C)within 3 days of enrollment or vaccination. Subject who has acute illness that was treated, symptoms resolved are eligible to enroll as long as treatment is complete \& symptoms resolved > 3 days prior to enrollment.
- Subject is currently participating or plans to participate in a study that involves an experimental agent (vaccine, drug, biologic, device, blood product, or medication) or has received an experimental agent within 1 month of enrollment in this study, or intends to donate blood during this period.
- Subject has any condition that would, in the opinion of the investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol
- Subject has a diagnosis of schizophrenia, bi-polar disease, or other severe (disabling) chronic psychiatric diagnosis, or are receiving psychiatric drugs. Subjects who are receiving a single anti-depressant drug \& are stable for at least 3 months prior to enrollment without decompensation are allowed enrollment into the study.
- Subject has a history of alcohol or drug abuse in the 5 years of enrollment.
- Subject has known human immunodeficiency virus, hepatitis B, or hepatitis C infection.
- Subject has a previous history of Guillain-Barre syndrome within 6 weeks of receipt of influenza vaccine
- Subject has any condition that the principal investigator (PI) believes may interfere with the successful completion of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Vaccine Research Unit Room 3-5000
Rochester, New York, 14642
About this study
Official title: Assessment of the Effect of Age and Priming on the Immunological Response to an Inactivated Vaccine for Novel H1N1 Virus.
The purpose of this study is to describe the immune response to a novel H1N1 influenza vaccination in healthy adults, and to understand the factors that allow healthy adults to respond to a single dose of vaccine even if they have never previously experience novel H1N1 disease or vaccination.
Read the detailed description
Studies have now determined that only a single dose of inactivated vaccine is needed for immunization against novel H1N1, but the reasons why adults appear to be ready to respond to a single dose are not known.
- Conditions
- Influenza
- Being tested
- Inactivated H1N1 vaccine
- Keywords
- 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.
Inactivated H1N1 vaccineBiological
Also called Influenza A (H1 N1) 2009 Monovalent Vaccine
0.5 ml IM into Deltoid region of arm
Inactivated H1N1 vaccineBiological
Also called Swine Flu Vaccine
0.5 mL IM X 1 dose
| Study group | Role | What they receive |
|---|---|---|
| Inactivated H1N1 Vaccine | Other | Subject will recieve 0.5 mL IM injection of Inactivated H1N1 vaccine Receives: Biological: Inactivated H1N1 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of Immune Response to Vaccination.
Number of participants with a 4-fold or greater increase in serum HAI antibody from pre- to 28 day post-vaccination
Measured: 28 days
Secondary outcomes (1)
Assessment of the Reactogenicity Events Post Vaccination.
Number of subjects with reactogenicity events of grade 2 or higher within 7 days of vaccination
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionNov 2010
- Study completionJul 2011
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 University of RochesterThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Treanor, University of Rochester
- Investigators
- John J. Treanor, M.D., Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01023711
- Sponsor's protocol ID
- URMC 09-005
- Status last verified
- Apr 2015
- First submitted
- 1 Dec 2009
- Last updated
- 12 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effect of Age and Priming on the Immunological Response to an Inactivated Vaccine for Novel H1N1 Virus.
- ClinicalTrials.gov ID
- NCT01023711
- Acronym / sponsor ID
- URMC 09-005
- Conditions
- Influenza
- Keywords
- Influenza
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 2 Dec 2009 (estimated)
- Results
- Posted 12 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to describe the immune response to a novel H1N1 influenza vaccination in healthy adults, and to understand the factors that allow healthy adults to respond to a single dose of vaccine even if they have never previously experience novel H1N1 disease or vaccination.
Detailed description
Studies have now determined that only a single dose of inactivated vaccine is needed for immunization against novel H1N1, but the reasons why adults appear to be ready to respond to a single dose are not known.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inactivated H1N1 Vaccine | Other | Biological: Inactivated H1N1 vaccineSubject will recieve 0.5 mL IM injection of Inactivated H1N1 vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18-32 years, or 60 years and older
- No history of Novel H1N1 virus or vaccine
- Female not able to bear children or not pregnant and agrees to practice effective birth control
- Female negative pregnancy test
- Good Health
Key exclusion criteria (18 listed)
- Previous history of vaccination against novel H1N1 or laboratory documented H1N1 infection
- Previous history of vaccination with A/New Jersey/76 vaccine (for subjects 60 \& older
- History of egg allergy or is allergic to other components of the vaccine
- Women who are pregnant or breastfeeding or intends to get pregnant during the study period between enrollment \& 30 days following vaccination
- Subject is immunosuppressed as the result of underlying illness or treatment with immunosuppressive or cytotoxic drugs or use of chemotherapy/radiation therapy in the preceding 36 months
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 |
|---|---|---|
| Inactivated H1N1 vaccineAlso: Influenza A (H1 N1) 2009 Monovalent Vaccine0.5 ml IM into Deltoid region of arm | Biological | Inactivated H1N1 Vaccine |
| Inactivated H1N1 vaccineAlso: Swine Flu Vaccine0.5 mL IM X 1 dose | Biological | Inactivated H1N1 Vaccine |
Primary outcome
Determination of Immune Response to Vaccination.
Time frame: 28 days
Number of participants with a 4-fold or greater increase in serum HAI antibody from pre- to 28 day post-vaccination
1 secondary outcome
Assessment of the Reactogenicity Events Post Vaccination.
Time frame: 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2015.
- 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.
John J. Treanor, M.D. principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inactivated H1N1 vaccine in people with Influenza, run by University of Rochester 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 7 inclusion and 18 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 12 May 2015. 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 12 May 2015). 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?
Determination of Immune Response to Vaccination. (time frame: 28 days). 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 12 May 2015.