InfluenzaPhase 3NCT00192231
Trial to Investigate Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine,(CAIV-T)
A Phase 3 study testing CAIV-T in people with Influenza, run by MedImmune LLC at 1 site in Australia.
Trial summary
The primary objective of this study was to perform a variety of immunological assays on blood, serum, nasal wash samples, and cells obtained from healthy adult subjects for the purpose of developing assays for application in the further investigation of immune responses generated by influenza virus vaccine, trivalent… 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?
- CAIV-T
- How many people
- 120 participants
- Where
- 1 siteAustralia
- Study dates
- Apr 2001to Jun 2001
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Healthy adults aged 18 to 59 years or > 60 years.
- Female subjects of childbearing potential who had a negative urine pregnancy test result prior to study vaccination. Females who were surgically sterilized or post-menopausal did not require pregnancy testing.
- Adults who were determined by medical history, physical examination and clinical judgment eligible for this study. Subjects with stable pre-existing disease, defined as disease not requiring change in therapy or hospitalization within 12 weeks before receipt of study vaccination, were eligible.
- Subjects who provided written informed consent after the nature of the study was explained.
- Subjects who were available for the duration of the study (from enrollment to study completion).
- Subjects who could be reached by study staff for the post-vaccination contact [via telephone, clinic or home visit].
Who cannot join
- Subjects who resided in a nursing home or long-term care facility or other institution receiving skilled or semi-skilled nursing care. An ambulatory subject who resided in a retirement home or village was eligible for participation.
- Subjects with evidence of dementia or other severe cognitive impairment based on Mini Mental State Examination (MMSE) score of 22 or greater. Note: Administration of MMSE was performed only if clinically indicated.
- For all study subjects:
- Subjects who were perceived to be unavailable or difficult to contact for evaluation of study visits during the study period.
- Subjects with a known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids; or cytotoxic agents.
- Subjects who received any blood products, including immunoglobulin, in the period from six months prior to vaccination through to the conclusion of the study.
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- Subjects who resided in the same household as an immunosuppressed or immunocompromised individual.
- Subjects with a documented history of hypersensitivity to egg or egg protein or any other component of the study vaccine or placebo.
- Subjects who were administered any live virus vaccine within one month prior to enrollment.
- Subjects for whom there was intent to administer any other investigational vaccine or agent from one month prior to enrollment through the conclusion of the study.
- Subjects who received a dose of influenza treatment (commercial or investigational) one month prior to enrollment. Prophylactic use of influenza antivirals was not permitted.
- Subjects who received any influenza vaccine in the six months prior to enrollment, or nonstudy influenza vaccine since enrollment.
- Subjects with any medical conditions that in the opinion of the investigator might interfere with the interpretation of the study results.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Austin & Repatriation Medical Centre
Heidelburg, Victoria, 3084
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial to Investigate Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine, Trivalent Types A & B, Live Cold Adapted (CAIV-T) in Healthy Adults Aged 18 and Older
The primary objective of this study was to perform a variety of immunological assays on blood, serum, nasal wash samples, and cells obtained from healthy adult subjects for the purpose of developing assays for application in the further investigation of immune responses generated by influenza virus vaccine, trivalent, types A and B, live, cold-adapted (liquid CAIV-T).
- Conditions
- Influenza
- Being tested
- CAIV-T
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAIV-TBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety objective was to assess the safety and tolerability of CAIV-T vaccine.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startApr 2001
- Study completionJun 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Investigators
- Robert Walker, MD, Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00192231
- Sponsor's protocol ID
- D153 P510
- Status last verified
- Oct 2006
- First submitted
- 12 Sep 2005
- Last updated
- 13 Sep 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Trial to Investigate Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine, Trivalent Types A & B, Live Cold Adapted (CAIV-T) in Healthy Adults Aged 18 and Older
- ClinicalTrials.gov ID
- NCT00192231
- Acronym / sponsor ID
- D153 P510
- Conditions
- Influenza
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Study start
- Apr 2001
- Study completion
- Jun 2001
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study was to perform a variety of immunological assays on blood, serum, nasal wash samples, and cells obtained from healthy adult subjects for the purpose of developing assays for application in the further investigation of immune responses generated by influenza virus vaccine, trivalent, types A and B, live, cold-adapted (liquid CAIV-T).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy adults aged 18 to 59 years or > 60 years.
- Female subjects of childbearing potential who had a negative urine pregnancy test result prior to study vaccination. Females who were surgically sterilized or post-menopausal did not require pregnancy testing.
- Adults who were determined by medical history, physical examination and clinical judgment eligible for this study. Subjects with stable pre-existing disease, defined as disease not requiring change in therapy or hospitalization within 12 weeks before receipt of study vaccination, were eligible.
- Subjects who provided written informed consent after the nature of the study was explained.
- Subjects who were available for the duration of the study (from enrollment to study completion).
Key exclusion criteria (13 listed)
- Subjects who resided in a nursing home or long-term care facility or other institution receiving skilled or semi-skilled nursing care. An ambulatory subject who resided in a retirement home or village was eligible for participation.
- Subjects with evidence of dementia or other severe cognitive impairment based on Mini Mental State Examination (MMSE) score of 22 or greater. Note: Administration of MMSE was performed only if clinically indicated.
- Subjects who were perceived to be unavailable or difficult to contact for evaluation of study visits during the study period.
- Subjects with a known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids; or cytotoxic agents.
- Subjects who received any blood products, including immunoglobulin, in the period from six months prior to vaccination through to the conclusion of the study.
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 |
|---|---|---|
| CAIV-T | Biological | – |
Primary outcome
The safety objective was to assess the safety and tolerability of CAIV-T vaccine.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
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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.
Robert Walker, MD study director
MedImmune LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CAIV-T in people with Influenza, run by MedImmune LLC at 1 site in Australia.
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 6 inclusion and 13 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 13 Sep 2021. 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 Australia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The safety objective was to assess the safety and tolerability of CAIV-T vaccine.. 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 13 Sep 2021.