HealthyPhase 3NCT00192335
Trial to Demonstrate Equivalent Immunogenicity of CAIV-T and FLUMIST in Healthy Participants
A Phase 3 study testing CAIV-T, CAIVT and FluMist in people with Healthy, run by MedImmune LLC at 3 sites in United States.
Trial summary
Primary objective is to demonstrate equivalent immunogeniticity of CAIV-T and FluMist Secondary objective of this study is to assess the safety and tolerability of CAIV-T compared to FluMist Read more about this study
- Who is it for?
- Ages 5 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CAIV-T, CAIVT and FluMist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 890 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2004to Feb 2005
- 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 5 to 49 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age 5 through 49 years (not yet reached their 50th birthday);
- In general good health;
- Individual or parent/guardian available by telephone;
- Ability of the participant or parent/guardian to understand and comply with the requirements of the protocol; and
- Written informed consent and HIPAA authorization obtained from the participant's parent or legal guardian or written informed consent and HIPAA authorization obtained from the participant.
Who cannot join
- History of hypersensitivity to any component of FluMist or CAIV-T, including egg or egg products;
- History of hypersensitivity to gentamicin;
- Any known immunosuppressive condition or immune deficiency disease (including HIV infection), or ongoing receipt of any immunosuppressive therapy;
- Household contact who is immunocompromised (participants should also avoid close contact with other immunocompromised individuals for at least 21 days);
- History of chronic underlying medical conditions such as chronic disorders of the cardiovascular and pulmonary systems, chronic metabolic diseases (including diabetes), renal dysfunction, or hemoglobinopathies;
- History of Guillain-Barré syndrome;
Show all 18Show fewer
- History of asthma or reactive airways disease;
- For children age 5 through 8 years, receipt of prior influenza vaccination;
- Acute febrile (>100.0°F oral) and/or respiratory illness within the 72 hours prior to enrollment;
- For participants under the age of 18, use of aspirin or aspirin containing products in the 30 days prior to enrollment or anticipated use during the study;
- Administration of any live vaccine within 30 days prior to enrollment or if receipt of another live vaccine is expected within 30 days of the vaccination in this study;
- Administration of any inactivated vaccine within two weeks prior to enrollment or if receipt of another inactivated vaccine is expected within two weeks of the vaccination in this study;
- Pregnancy or, in biologically capable women (e.g., menses within the last year), not willing to agree to acceptable birth control for 90 days after enrolling into the study (for those biologically capable, a urine pregnancy test must be performed on the day of vaccination with a negative result);
- Breastfeeding or lactating women;
- Participation in another investigational trial or administration of any investigational drug within 30 days prior to enrollment or during this study;
- Receipt of any blood product within 90 days prior to vaccination or expected receipt within the study duration;
- Employees of the research center, any individuals involved with the conduct of the study, or any family member of such individuals; and
- Any condition that in the opinion of the investigator would interfere with the interpretation or evaluation of the vaccine.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Kentucky Pediatric/Adult Research, Inc.
Bardstown, Kentucky, 40004
R/D Clinical Research, Inc.
Lake Jackson, Texas, 77566
Heart of America Research Institute
Shawnee Mission, Kansas, 66216
About this study
Official title: A Prospective, Double-Blind, Randomized Trial to Demonstrate Equivalent Immunogenicity of CAIV-T and FLUMIST in Healthy Participants Ages 5 Through 49 Years
- Primary objective is to demonstrate equivalent immunogeniticity of CAIV-T and FluMist
- Secondary objective of this study is to assess the safety and tolerability of CAIV-T compared to FluMist
- Conditions
- Healthy
- Being tested
- CAIV-T, CAIVT, FluMist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAIV-TBiological
CAIVTBiological
The total volume of 0.2 mL will be administered intranasally with a spray applicator (approximately 0.1 mL into each nostril).
FluMistBiological
The total volume of 0.5 mL will be administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | CAIVT-The total volume of 0.2 mL will be administered intranasally with a spray applicator (approximately 0.1 mL into each nostril). Receives: Biological: CAIV-T; Biological: CAIVT |
| 2 | Active comparator | FluMist- The total volume of 0.5 mL will be administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Receives: Biological: FluMist |
What is being measured
The primary outcome is the main question the study is designed to answer.
- Among participants 5 through 8 years of age regardless of baseline serostatus who receive two doses, the post-dose two strain-specific geometric mean titers (GMTs) for serum HAI in the CAIV-T group are within 2-fold of those in the FluMist group
Measured: greater than 28-days post dose
Secondary outcomes (1)
The proportion of participants experiencing each of the reactogenicity events by dose.
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 posted19 Sep 2005 (estimated)
- Study startJul 2004
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 890 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Luis Angles, MD, Principal investigator, Heart of America Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00192335
- Sponsor's protocol ID
- MI-CP112
- Status last verified
- Nov 2007
- First submitted
- 12 Sep 2005
- Last updated
- 27 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Double-Blind, Randomized Trial to Demonstrate Equivalent Immunogenicity of CAIV-T and FLUMIST in Healthy Participants Ages 5 Through 49 Years
- ClinicalTrials.gov ID
- NCT00192335
- Acronym / sponsor ID
- MI-CP112
- Conditions
- Healthy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 890 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Study completion
- Feb 2005 (actual)
- 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.
- Primary objective is to demonstrate equivalent immunogeniticity of CAIV-T and FluMist
- Secondary objective of this study is to assess the safety and tolerability of CAIV-T compared to FluMist
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Biological: CAIV-T, Biological: CAIVTCAIVT-The total volume of 0.2 mL will be administered intranasally with a spray applicator (approximately 0.1 mL into each nostril). |
| 2 | Active comparator | Biological: FluMistFluMist- The total volume of 0.5 mL will be administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). |
Who may qualify
- Ages
- 5 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age 5 through 49 years (not yet reached their 50th birthday);
- In general good health;
- Individual or parent/guardian available by telephone;
- Ability of the participant or parent/guardian to understand and comply with the requirements of the protocol; and
- Written informed consent and HIPAA authorization obtained from the participant's parent or legal guardian or written informed consent and HIPAA authorization obtained from the participant.
Key exclusion criteria (18 listed)
- History of hypersensitivity to any component of FluMist or CAIV-T, including egg or egg products;
- History of hypersensitivity to gentamicin;
- Any known immunosuppressive condition or immune deficiency disease (including HIV infection), or ongoing receipt of any immunosuppressive therapy;
- Household contact who is immunocompromised (participants should also avoid close contact with other immunocompromised individuals for at least 21 days);
- History of chronic underlying medical conditions such as chronic disorders of the cardiovascular and pulmonary systems, chronic metabolic diseases (including diabetes), renal dysfunction, or hemoglobinopathies;
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 | 1 |
| CAIVTThe total volume of 0.2 mL will be administered intranasally with a spray applicator (approximately 0.1 mL into each nostril). | Biological | 1 |
| FluMistThe total volume of 0.5 mL will be administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). | Biological | 2 |
Primary outcome
- Among participants 5 through 8 years of age regardless of baseline serostatus who receive two doses, the post-dose two strain-specific geometric mean titers (GMTs) for serum HAI in the CAIV-T group are within 2-fold of those in the FluMist group
Time frame: greater than 28-days post dose
1 secondary outcome
The proportion of participants experiencing each of the reactogenicity events by dose.
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 27 Nov 2007.
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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.
Luis Angles, MD principal investigator
Heart of America Research Institute
3 sites 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, CAIVT and FluMist in people with Healthy, run by MedImmune LLC at 3 sites 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 5 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 27 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 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?
- Among participants 5 through 8 years of age regardless of baseline serostatus who receive two doses, the post-dose two strain-specific geometric mean titers (GMTs) for serum HAI in the CAIV-T group are within 2-fold of those in the FluMist group (time frame: greater than 28-days post dose). 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 27 Nov 2007.