InfluenzaPhase 3NCT00192361
Trial of the Safety, Transmissibility, and Phenotypic and Genotypic Stability of Influenza Virus Vaccine,(CAIV-T), in Children Who Attend Day Care. (Final Report Version 2.0)
A Phase 3 study testing CAIV-T in people with Influenza, run by MedImmune LLC at 1 site in Finland.
Trial summary
To assess whether CAIV-T was transmitted from vaccinated children to their unvaccinated contacts in a day care setting; and if so, to estimate the rate of transmission. Read more about this study
- Who is it for?
- Ages 8 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- CAIV-T
- How many people
- 200 participants
- Where
- 1 siteFinland
- Study dates
- Nov 1999to not given
- 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 8 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- who were at least 8 months and less than 36 months of age (had not reached their 3rd birthday) at the time of enrollment, and in good health as determined by medical history, physical examination, and clinical judgment;
- whose parent or legal guardian had provided written informed consent after the nature of the study had been explained;
- who, along with their parent or legal guardian, were available for the duration of the study (42 days post-vaccination of first study dose or 42 days post-vaccination of supplemental dose of CAIV-T);
- whose parent/legal guardian could be reached by telephone by study staff for the postimmunization contacts;
- who attended day care at least three days per week and four hours per day;
- who was one of at least 4 children in a contact group/playroom (at least 4 children in such a group were required to be randomized in the study).
Who cannot join
- whose parents or legal guardians were perceived to be unreliable or unavailable 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 and asthma;
- 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 was 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 in the same playroom or 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);
- with a documented history of hypersensitivity to egg or egg protein;
- 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 whom use was anticipated during the study;
- who were administered any live virus vaccine within one month prior to enrollment or expected receipt of another live virus vaccine within one month of vaccination in this study;
- who were administered any inactivated vaccine within two weeks prior to enrollment or expected receipt of another inactivated vaccine within three weeks of vaccination in this study;
- with any medical conditions that in the opinion of the investigator might interfere with interpretation of the study results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind Trial of the Safety, Transmissibility, and Phenotypic and Genotypic Stability of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (CAIV-T), in Children Who Attend Day Care. (Final Report Version 2.0)
To assess whether CAIV-T was transmitted from vaccinated children to their unvaccinated contacts in a day care setting; and if so, to estimate the rate of transmission.
- 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 primary endpoint of the study was the determination of the proportion of placebo recipients from whom any of the vaccine strains were isolated.
Secondary outcomes (5)
The endpoint for children who received CAIV-T was the first nasal swab scored positive for viral shedding in
which the vaccine virus phenotype (cold-adapted and temperature sensitive) or genotype (6:2 reassortant) was
not preserved. Genotypic and phenotypic stability were summarized as the proportion of all vaccine viruspositive
isolates which retained the cold-adapted phenotype, temperature-sensitive phenotype or the 6:2
reassortant genotype of the vaccine strains.
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 startNov 1999
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
- 200 participants
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Robert Walker, MD, Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00192361
- Sponsor's protocol ID
- D153 P500
- Status last verified
- Oct 2006
- First submitted
- 12 Sep 2005
- Last updated
- 25 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind Trial of the Safety, Transmissibility, and Phenotypic and Genotypic Stability of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (CAIV-T), in Children Who Attend Day Care. (Final Report Version 2.0)
- ClinicalTrials.gov ID
- NCT00192361
- Acronym / sponsor ID
- D153 P500
- Conditions
- Influenza
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 1999
- 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.
To assess whether CAIV-T was transmitted from vaccinated children to their unvaccinated contacts in a day care setting; and if so, to estimate the rate of transmission.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 8 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- who were at least 8 months and less than 36 months of age (had not reached their 3rd birthday) at the time of enrollment, and in good health as determined by medical history, physical examination, and clinical judgment;
- whose parent or legal guardian had provided written informed consent after the nature of the study had been explained;
- who, along with their parent or legal guardian, were available for the duration of the study (42 days post-vaccination of first study dose or 42 days post-vaccination of supplemental dose of CAIV-T);
- whose parent/legal guardian could be reached by telephone by study staff for the postimmunization contacts;
- who attended day care at least three days per week and four hours per day;
Key exclusion criteria (14 listed)
- whose parents or legal guardians were perceived to be unreliable or unavailable 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 and asthma;
- 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 | Biological | – |
Primary outcome
The primary endpoint of the study was the determination of the proportion of placebo recipients from whom any of the vaccine strains were isolated.
5 secondary outcomes
The endpoint for children who received CAIV-T was the first nasal swab scored positive for viral shedding in
which the vaccine virus phenotype (cold-adapted and temperature sensitive) or genotype (6:2 reassortant) was
not preserved. Genotypic and phenotypic stability were summarized as the proportion of all vaccine viruspositive
isolates which retained the cold-adapted phenotype, temperature-sensitive phenotype or the 6:2
reassortant genotype of the vaccine strains.
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 25 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 in people with Influenza, run by MedImmune LLC at 1 site in Finland.
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 14 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 25 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 Finland. 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 of the study was the determination of the proportion of placebo recipients from whom any of the vaccine strains were isolated.. 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 25 Oct 2006.