InfluenzaPhase 4NCT01023776
Infectivity, Replication & Immunogenicity of Live nH1N1 Vaccine
A Phase 4 study testing A/California/07/09 live monovalent H1N1 vaccine in people with Influenza, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of the study is to determine the amount of live virus that can be recovered from the nose of people who are vaccinated with the licensed live vaccine against H1N1, and to describe the immune response to vaccination. Read more about this study
- Who is it for?
- Ages 18 to 32 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- A/California/07/09 live monovalent H1N1 vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Jul 2010
- 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 18 to 32 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18-32 years, inclusive
- 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
- History of egg allergy or is allergic to other components of the vaccine
- A women who is pregnant or breastfeeding or intends to get pregnant during the study period between enrollment and 30 days following vaccination
- Subject is immunosuppressed as the result of underlying illness or treatment with immunosuppressive or cytotoxic drugs or use of chemotherapy or 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
- 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 and topical steroids allowed)
Show all 16Show fewer
- Received immunoglobulin or another 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 in this study or plans to receive another vaccine within the next 28 days (or 56 days for the vaccine naive recipients)
- 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 degrees F(37.7 C)within 3 days prior to enrollment or vaccination. Subject who has acute illness that was treated, symptoms resolved are eligible to enroll as long as treatment is complete and symptoms resolved > 3 dyas 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 prior to enrollment in this study, or intends to donate blood during this period.
- Subject has any condition that would, in the opinion of the site 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 history of alcohol or drug abuse in the 5 years prior to 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: Evaluation of the Infectivity, Replication, and Immunogenicity of Live, Attenuated A/California/07/09 (nH1N1) Influenza Vaccine in Serosusceptible Adults
The purpose of the study is to determine the amount of live virus that can be recovered from the nose of people who are vaccinated with the licensed live vaccine against H1N1, and to describe the immune response to vaccination.
Read the detailed description
By looking at the immune response before and after vaccine, we hope to understand the factors that determine the immune response and detailed shedding patterns of live novel H1N1 vaccine.
- Conditions
- Influenza
- Being tested
- A/California/07/09 live monovalent H1N1 vaccine
- Keywords
- Swine Flu, H1N1
- Medical subject headings
- Influenza, Human, Orthomyxoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A/California/07/09 live monovalent H1N1 vaccineBiological
Also called Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal
0.1mL per nares intranasally, second identical dose given 28 days after first vaccine
| Study group | Role | What they receive |
|---|---|---|
| live monovalent H1N1 vaccine | Other | A/California/07/09 live monovalent H1N1 vaccine 0.2 given intranasally, 2 doses given 28 days apart Receives: Biological: A/California/07/09 live monovalent H1N1 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Shed Virus
number of participants who shed virus above the limit of detection at any timepoint after vaccine. The limit of detection is 0.5 tissue culture infectious doses per mL of nasal wash.
Measured: 28 days post vaccine 1 and 28 days vaccine 2
Secondary outcomes (1)
Mean Difference Between Cycle Time and Detection Threshold
The mean difference was calculated by real-time polymerase chain reaction (PCR) on nasal wash samples. Cycle time is the cycle number at which the PCR reaction is positive with a range of 0-40 cycles. The detection threshold is 40 cycles.
Measured: day 10 post vaccine 1
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 completionApr 2010
- Study completionJul 2010
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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT01023776
- Sponsor's protocol ID
- URMC 09-006
- Status last verified
- Nov 2015
- First submitted
- 1 Dec 2009
- Last updated
- 23 Dec 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 23 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Infectivity, Replication, and Immunogenicity of Live, Attenuated A/California/07/09 (nH1N1) Influenza Vaccine in Serosusceptible Adults
- ClinicalTrials.gov ID
- NCT01023776
- Acronym / sponsor ID
- URMC 09-006
- Conditions
- Influenza
- Keywords
- Swine Flu, H1N1
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 2 Dec 2009 (estimated)
- Results
- Posted 23 Dec 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 the study is to determine the amount of live virus that can be recovered from the nose of people who are vaccinated with the licensed live vaccine against H1N1, and to describe the immune response to vaccination.
Detailed description
By looking at the immune response before and after vaccine, we hope to understand the factors that determine the immune response and detailed shedding patterns of live novel H1N1 vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| live monovalent H1N1 vaccine | Other | Biological: A/California/07/09 live monovalent H1N1 vaccineA/California/07/09 live monovalent H1N1 vaccine 0.2 given intranasally, 2 doses given 28 days apart |
Who may qualify
- Ages
- 18 to 32 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Aged 18-32 years, inclusive
- 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 (16 listed)
- Previous history of vaccination against novel H1N1 or laboratory documented H1N1 infection
- History of egg allergy or is allergic to other components of the vaccine
- A women who is pregnant or breastfeeding or intends to get pregnant during the study period between enrollment and 30 days following vaccination
- Subject is immunosuppressed as the result of underlying illness or treatment with immunosuppressive or cytotoxic drugs or use of chemotherapy or 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
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 |
|---|---|---|
| A/California/07/09 live monovalent H1N1 vaccineAlso: Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal0.1mL per nares intranasally, second identical dose given 28 days after first vaccine | Biological | live monovalent H1N1 vaccine |
Primary outcome
Number of Participants Who Shed Virus
Time frame: 28 days post vaccine 1 and 28 days vaccine 2
number of participants who shed virus above the limit of detection at any timepoint after vaccine. The limit of detection is 0.5 tissue culture infectious doses per mL of nasal wash.
1 secondary outcome
Mean Difference Between Cycle Time and Detection Threshold
Time frame: day 10 post vaccine 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 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 Phase 4 study testing A/California/07/09 live monovalent 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 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 23 Dec 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.
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 23 Dec 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?
Number of Participants Who Shed Virus (time frame: 28 days post vaccine 1 and 28 days vaccine 2). 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 23 Dec 2015.