Healthy Japanese Male AdultsPhase 1NCT00224783
Phase I Trial Evaluating Safety and Tolerability of CAIV-T in Healthy Japanese Male Adults
A Phase 1 study testing CAIV-T in people with Healthy Japanese Male Adults, run by MedImmune LLC.
Trial summary
The primary objective of the study was to investigate the safety and tolerability of CAIV-T liquid formulation in healthy Japanese male adults. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Japanese Male Adults
- What is being tested?
- CAIV-T
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Aug 2002to Sep 2002
- Phase
- Phase 1
- 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age of 20 years old or over but below 45 years old (at the time of consent)
- Persons judged suitable by the principal investigator or investigator from the results of prior history, physical examination and clinical findings.
- Persons having the ability to understand consent and a written consent obtained prior to the start of screening.
- Persons being able to participate in the trial for 1 month from the inoculation of the trial vaccine to the completion of the trial.
- Persons being able to be contacted (by phone, hospital visit or house visit) by the trial staff at the time of testing after 28 days from the inoculation of the trial vaccine.
Who cannot join
- Persons judged to be impossible or difficult to contact for requesting hospital visits to carry out clinical evaluation and tests during the trial term.
- Persons having a prior history of or suspected immunological disease, or those receiving administration of systemic corticosteroids or immunosuppressants such as cytotoxic drugs (e.g., methotrexate, etc.)
- Persons having blood formulations such as immunoglobulin, etc., administered or planned during a period from one month before the inoculation of the trial vaccine to the completion of the trial.
- Persons living with any person with a nonfunctional or suppressed immune system (by using immunosuppressants, etc.), in the same household.
- Persons with a prior history of hypersensitivity to chicken eggs or chicken egg proteins or components of the trial vaccine (such as sucrose, phosphoric acid, glutamate, arginine and acid-hydrolyzed pig gelatin).
- Persons inoculated with a live virus vaccine within 1 month before screening.
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- Persons having the planned administration of another trial vaccine or drug during the period from one month before screening to the completion of the trial
- Person having an influenza treatment drug (such as commercially available drugs or trial vaccines: for example, Oseltamivir, Zanamivir, Amantadine, etc.), administered within one month before screening. Incidentally, no prophylactic administration of an influenza viral drug was permitted.
- Persons inoculated with an influenza vaccine within 6 months before screening or planned to be inoculated with an influenza vaccine during the term of the present trial.
- Persons with blood drawn quantity (including blood donation) of 400 mL or more within 3 months or 200 mL or more within 1 month before screening.
- Persons with a history of any febrile disorders (oral cavity temperature ³ 38.0°C) or other acute disorders within 36 hours before trial vaccine inoculation.
- Persons who had upper respiratory tract disorders themselves or whose family members had such disorders within 72 hours before trial vaccine inoculation.
- Persons treated with an antibiotic within 72 hours before trial vaccine inoculation.
- Persons with an acute asthmatic symptom.
- Persons judged to have a pathology preventing the evaluation of the trial effect by the principal investigator (or investigator).
About this study
Official title: Placebo-controlled Double-blind Controlled Trial of Single Intranasal Inoculation of CAIV-T Liquid Formulation in Healthy Japanese Male Adults
The primary objective of the study was to investigate the safety and tolerability of CAIV-T liquid formulation in healthy Japanese male adults.
Read the detailed description
The primary objective of the study was to investigate the safety and tolerability of CAIV-T liquid formulation in healthy Japanese male adults by evaluating the incidence of influenza-like symptoms, and the type, incidence, and severity of adverse events.
- Conditions
- Healthy Japanese Male Adults
- Being tested
- CAIV-T, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAIV-TBiological
Also called 0.2 mL, by nebulizer
Trivalent cold adapted temperature sensitive attenuated Types A and Type B influenza virus live vaccine (CAIV-T)
PlaceboBiological
0.2 mL of 0.01 mol/L potassium phosphate buffer containing 0.85% sodium chloride (pH 7.2).
| Study group | Role | What they receive |
|---|---|---|
| CAIV-T | Active comparator | CAIV-T contains 3 cold-adapted influenza virus strains (A/H1N1, A/H3N2, B) concentrated and refined by centrifugal separation from the chorioallantoic membrane of specific pathogen-free (SPF) eggs, containing SPG (sucrose-phosphate-glutamate), arginine, and acid hydrolyzed pig gelatin as stabilizers. Subjects were inoculated once with about 0.1 mL of investigational vaccine in each nasal cavity (a total of 0.2 mL) using a nebulizer. Receives: Biological: CAIV-T |
| Placebo | Placebo comparator | Placebo contained 0.01 mol/L potassium phosphate buffer containing 0.85% sodium chloride (pH 7.2). Subjects received about 0.1 mL (a total 0.2 mL) of the control drug using a nebulizer. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of subjects within each treatment arm who experienced influenza-like symptoms
Influenza-like symptoms, ie, typical clinical symptoms of influenza infection, including fever (oral temperature > or = 38 degrees C), cough, runny or stuffy nose, sore throat, headache, chills, muscular pain, vomiting, decline in activity, decline in appetite.
Measured: Within 6 days post vaccination
Secondary outcomes (1)
The number of subjects within each treatment arm who experienced adverse events
Adverse events were classified according to the "Glossary of Side Effects of Pharmaceutical Agents, 1996."
Measured: Within 28 days of vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2005 (estimated)
- Study startAug 2002
- Study completionSep 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Japanese Male AdultsStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 45 participants (actual)
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
- NCT00224783
- Sponsor's protocol ID
- D153 P800
- Status last verified
- Jan 2012
- First submitted
- 20 Sep 2005
- Last updated
- 26 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-controlled Double-blind Controlled Trial of Single Intranasal Inoculation of CAIV-T Liquid Formulation in Healthy Japanese Male Adults
- ClinicalTrials.gov ID
- NCT00224783
- Acronym / sponsor ID
- D153 P800
- Conditions
- Healthy Japanese Male Adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Study start
- Aug 2002
- Study completion
- Sep 2002 (actual)
- First posted
- 23 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 the study was to investigate the safety and tolerability of CAIV-T liquid formulation in healthy Japanese male adults.
Detailed description
The primary objective of the study was to investigate the safety and tolerability of CAIV-T liquid formulation in healthy Japanese male adults by evaluating the incidence of influenza-like symptoms, and the type, incidence, and severity of adverse events.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAIV-T | Active comparator | Biological: CAIV-TCAIV-T contains 3 cold-adapted influenza virus strains (A/H1N1, A/H3N2, B) concentrated and refined by centrifugal separation from the chorioallantoic membrane of specific pathogen-free (SPF) eggs, containing SPG (sucrose-phosphate-glutamate), arginine, and acid hydrolyzed pig gelatin as stabilizers. Subjects were inoculated once with about 0.1 mL of investigational vaccine in each nasal cavity (a total of 0.2 mL) using a nebulizer. |
| Placebo | Placebo comparator | Biological: PlaceboPlacebo contained 0.01 mol/L potassium phosphate buffer containing 0.85% sodium chloride (pH 7.2). Subjects received about 0.1 mL (a total 0.2 mL) of the control drug using a nebulizer. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age of 20 years old or over but below 45 years old (at the time of consent)
- Persons judged suitable by the principal investigator or investigator from the results of prior history, physical examination and clinical findings.
- Persons having the ability to understand consent and a written consent obtained prior to the start of screening.
- Persons being able to participate in the trial for 1 month from the inoculation of the trial vaccine to the completion of the trial.
- Persons being able to be contacted (by phone, hospital visit or house visit) by the trial staff at the time of testing after 28 days from the inoculation of the trial vaccine.
Key exclusion criteria (15 listed)
- Persons judged to be impossible or difficult to contact for requesting hospital visits to carry out clinical evaluation and tests during the trial term.
- Persons having a prior history of or suspected immunological disease, or those receiving administration of systemic corticosteroids or immunosuppressants such as cytotoxic drugs (e.g., methotrexate, etc.)
- Persons having blood formulations such as immunoglobulin, etc., administered or planned during a period from one month before the inoculation of the trial vaccine to the completion of the trial.
- Persons living with any person with a nonfunctional or suppressed immune system (by using immunosuppressants, etc.), in the same household.
- Persons with a prior history of hypersensitivity to chicken eggs or chicken egg proteins or components of the trial vaccine (such as sucrose, phosphoric acid, glutamate, arginine and acid-hydrolyzed pig gelatin).
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-TAlso: 0.2 mL, by nebulizerTrivalent cold adapted temperature sensitive attenuated Types A and Type B influenza virus live vaccine (CAIV-T) | Biological | CAIV-T |
| Placebo0.2 mL of 0.01 mol/L potassium phosphate buffer containing 0.85% sodium chloride (pH 7.2). | Biological | Placebo |
Primary outcome
The number of subjects within each treatment arm who experienced influenza-like symptoms
Time frame: Within 6 days post vaccination
Influenza-like symptoms, ie, typical clinical symptoms of influenza infection, including fever (oral temperature > or = 38 degrees C), cough, runny or stuffy nose, sore throat, headache, chills, muscular pain, vomiting, decline in activity, decline in appetite.
1 secondary outcome
The number of subjects within each treatment arm who experienced adverse events
Time frame: Within 28 days of vaccination
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 26 Jan 2012.
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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
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CAIV-T in people with Healthy Japanese Male Adults, run by MedImmune LLC.
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 5 inclusion and 15 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 26 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 number of subjects within each treatment arm who experienced influenza-like symptoms (time frame: Within 6 days 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 26 Jan 2012.