HealthyPhase 3NCT00192244
Trial to Determine the Safety and Efficacy of Influenza Virus Vaccine, Trivalent, Types A & B, Live, Cold-Adapted (CAIV-T) in Healthy Children
A Phase 3 study testing CAIV-T, Liquid in people with Healthy, run by MedImmune LLC at 1 site in China.
Trial summary
The purpose of this study is to determine the efficacy of CAIV-T in a diverse Asian population aged from 6 months to less than 36 months, in tropical and temperate climates, against culture-confirmed influenza illness. Read more about this study
- Who is it for?
- Ages 6 to 35 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CAIV-T, Liquid
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- Sep 2000to Oct 2002
- 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 6 to 35 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- who are greater than or equal to 6 months and less than 36 months of age at the time of enrollment, and in good health as determined by medical history, physical examination, and clinical judgment;
- whose parent or legal guardian has provided written informed consent after the nature of the study has been explained;
- who, along with their parent or legal guardian, will be available for the duration of the study (24 months);
- whose parent/legal guardian can be reached by study staff for the post-immunization contacts [via telephone, clinic or home visits].
Who cannot join
- whose parents or caregiver are perceived to be unreliable or difficult to contact for evaluation or study visits during the study period;
- with any serious chronic disease (e.g., with signs of cardiac or renal failure or severe malnutrition), including progressive neurological disease;
- with Down's syndrome or other known cytogenetic disorders;
- with a known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids;
- who received any blood products, including immunoglobulin, in the period from six months prior to vaccination through to the conclusion of the study;
- for whom there is intent to administer any other investigational vaccine or agent from one month prior to enrollment through to the conclusion of the study;
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- with an immunosuppressed or compromised individual living in the same household;
- who, at any time prior to entry into this study, received a dose of any influenza vaccine (commercial or investigational);
- who were administered any live virus vaccine within one month prior to study vaccination or expected receipt of another live virus within one month of vaccination in this study;
- with a documented history of hypersensitivity to egg or egg protein, or any other component of the study vaccines or placebo;
- with a respiratory illness with wheezing within two weeks prior to enrollment;
- who received aspirin (acetylsalicylic acid) or aspirin-containing products in the two weeks prior to enrollment or for which use is anticipated during the study;
- with any medical conditions that in the opinion of the Investigator might interfere with interpretation of the study results; Note: A pregnant household member or day care provider is not considered a contraindication to enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Trial to Determine the Safety and Efficacy of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (CAIV-T) in Healthy Children
- The purpose of this study is to determine the efficacy of CAIV-T in a diverse Asian population aged from 6 months to less than 36 months, in tropical and temperate climates, against culture-confirmed influenza illness. In addition, the trial provides the opportunity to investigate the efficacy of CAIV-T over multiple influenza seasons, and to investigate the effect of CAIV-T on acute otitis media.
- Conditions
- Healthy
- Being tested
- CAIV-T, Liquid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAIV-T, LiquidBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint for efficacy is the first episode during the first year in a study child of a culture-confirmed influenza-illness, caused by community-acquired subtypes.
Secondary outcomes (1)
The secondary endpoint for efficacy is the first episode during the second year in a study child of a culture-confirmed influenza-illness.
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 startSep 2000
- Study completionOct 2002
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 3,000 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
- NCT00192244
- Sponsor's protocol ID
- D153-P501
- Status last verified
- Oct 2006
- First submitted
- 12 Sep 2005
- Last updated
- 3 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-Blind, Placebo-Controlled, Trial to Determine the Safety and Efficacy of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (CAIV-T) in Healthy Children
- ClinicalTrials.gov ID
- NCT00192244
- Acronym / sponsor ID
- D153-P501
- Conditions
- Healthy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,000 participants
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Study start
- Sep 2000
- Study completion
- Oct 2002
- 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 purpose of this study is to determine the efficacy of CAIV-T in a diverse Asian population aged from 6 months to less than 36 months, in tropical and temperate climates, against culture-confirmed influenza illness. In addition, the trial provides the opportunity to investigate the efficacy of CAIV-T over multiple influenza seasons, and to investigate the effect of CAIV-T on acute otitis media.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 6 to 35 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- who are greater than or equal to 6 months and less than 36 months of age at the time of enrollment, and in good health as determined by medical history, physical examination, and clinical judgment;
- whose parent or legal guardian has provided written informed consent after the nature of the study has been explained;
- who, along with their parent or legal guardian, will be available for the duration of the study (24 months);
- whose parent/legal guardian can be reached by study staff for the post-immunization contacts [via telephone, clinic or home visits].
Key exclusion criteria (13 listed)
- whose parents or caregiver are perceived to be unreliable or difficult to contact for evaluation or study visits during the study period;
- with any serious chronic disease (e.g., with signs of cardiac or renal failure or severe malnutrition), including progressive neurological disease;
- with Down's syndrome or other known cytogenetic disorders;
- with a known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids;
- 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, Liquid | Biological | – |
Primary outcome
The primary endpoint for efficacy is the first episode during the first year in a study child of a culture-confirmed influenza-illness, caused by community-acquired subtypes.
1 secondary outcome
The secondary endpoint for efficacy is the first episode during the second year in a study child of a culture-confirmed influenza-illness.
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 3 Oct 2006.
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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, Liquid in people with Healthy, run by MedImmune LLC at 1 site in China.
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 4 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 3 Oct 2006. 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 China. 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 primary endpoint for efficacy is the first episode during the first year in a study child of a culture-confirmed influenza-illness, caused by community-acquired subtypes.. 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 3 Oct 2006.