HealthyPhase 2FluMistNCT00192270
Trial to Assess Safety, Tolerability, and Immunogenicity of Influenza Virus Vaccine, Trivalent, Types A and B, Live Cold-adapted (CAIV-T) in Healthy Children
A Phase 2 study testing CAIV-T in people with Healthy, run by MedImmune LLC at 3 sites in 2 countries.
Trial summary
The study was designed to determine the number of doses of CAIV-T required to effectively immunize children and adolescents in the 6 to 17 year age group. Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CAIV-T
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 498 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Oct 2000to Jan 2001
- Phase
- Phase 2
- 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 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- who are at least 6 years and not more than 17 years of age at the time of enrollment;
- who, if female and is post-menarche, has provided a negative pregnancy test; · who are in good health as determined by medical history, physical examination and clinical judgement;
- who have provided written informed consent (as appropriate and according to national guidelines) and whose parent(s) or legal guardian(s) have provided written informed consent after the nature of the study has been explained; 13 who, along with their parent(s) or legal guardian(s), will be available for duration of the study (approximately three months);
- who, together with their parent(s) or legal guardian(s), can be reached by study staff for the post-vaccination contacts [telephone, clinic visit or home visit].
Who cannot join
- who are perceived to be unavailable or difficult to contact for evaluation or study visits during the study period and whose parent(s) or legal guardian(s) 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;
Show all 15Show fewer
- have an immunosuppressed or immuno-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, in the two weeks prior to entry into this study, received a dose of any influenza treatment (commercial or investigational)
- with a documented history of hypersensitivity to egg or egg protein or any other component of the study vaccine;
- with a clinically confirmed 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;
- who were administered any live virus vaccine within one month prior to enrollment or expect receipt of another live virus vaccine within one month of vaccination in this study;
- with any medical conditions that in the opinion of the investigator might interfere with interpretation of the study results; If any of these criteria are met following enrolment, the subject will be excluded from subsequent vaccine dosing.
- Note: A pregnant household member is not considered a contraindication to enrollment.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Belgium2 sites
University of Antwerp
Antwerp, 2610
Dienst Jeugdgezondheidszorg
Leuven, 3000
About this study
Official title: A Prospective, Open-label, Phase II, Multi-center Study of the Safety, Tolerability and Immunogenicity of Influenza Virus Vaccine, Trivalent, Types A and B, Live Cold-adapted (CAIV-T) in Healthy Children, Aged 6 to 17 Years
The study was designed to determine the number of doses of CAIV-T required to effectively immunize children and adolescents in the 6 to 17 year age group.
Read the detailed description
This was a phase II, prospective, open-label, multicenter, outpatient study designed to evaluate the safety, tolerability, and immunogenicity of one or two doses of CAIV-T in children and adolescents between 6 and 17 years of age. Subjects were allocated to one of three study groups according to age at the time of enrollment: study group one consisted of subjects between 6 and 9 years of age, group two of subjects 10 to 12 years of age, and group three of subjects 13 to 17 years of age.
Approximately 450 subjects (ie, 150 subjects per age group) participated in the study and were scheduled to receive two intranasal doses of CAIV-T separated by 35 ± 7 days in an open-label manner.
- Conditions
- Healthy
- Being tested
- CAIV-T
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAIV-TBiological
Also called FluMist
Each dose of the vaccine was formulated to contain approximately 1 x 10^7 TCID50 of each of three (two subtype A and one subtype B) reassortant 6:2 influenza strains, as described above, for a total of ~3 x 10^7 TCID50 per dose.
| Study group | Role | What they receive |
|---|---|---|
| Cold-adapted influenza vaccine trivalent (CAIV-T) | Experimental | All subjects were scheduled to receive 2 doses of CAIV-T.The total volume of 0.2 mL was administered intranasally with a spray applicator (approximately 0.1 mL into each nostril). Receives: Biological: CAIV-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of subjects achieving strain-specific hemagglutination inhibition (HAI) antibody seroconversion post Dose 1
Immunogenicity was evaluated by comparison of pre and post-vaccination strain-specific titers of serum HAI antibody. Seroconversion was defined as a four-fold or greater rise in serum HAI antibody titer.
Measured: Day 0, Day 35 post Dose 1
Secondary outcomes (4)
The number of subjects achieving strain-specific HAI antibody seroconversion post Dose 1
Immunogenicity was evaluated by comparison of pre and post-vaccination strain-specific titers of serum HAI antibody. Seroconversion was defined as a four-fold or greater rise in serum HAI antibody titer.
Measured: Day 0, Day 35 post Dose 2
The number of subjects reporting any reactogenicity event post dose
Reactogenicity events were predefined adverse events that could have occurred after vaccine administration. They included the following: fever (oral temperature >= 38C), cough, runny nose/nasal congestion, sore throat, irritability, headache, chills, vomiting, decreased activity, decreased appetite, and muscle aches.
Measured: Days 0-10
The number of subjects reporting any adverse event post dose
An adverse event (or adverse experience, AE) was defined as any untoward medical occurrence in a subject who was administered a study product.
Measured: Days 0-10
The number of subjects reporting serious adverse events post dose
An adverse event was considered serious (SAE) if it: resulted in death, regardless of cause; was life-threatening (subject was at risk of death as the event occurred); required inpatient hospitalization or prolonged existing hospitalization; resulted in persistent or significant disability/incapacity; or resulted in a congenital anomaly or birth defect (in the offspring of a vaccine recipient, where applicable).
Measured: Days 0-42
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 startOct 2000
- Primary completionJan 2001
- Study completionJan 2001
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 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 498 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
- Raburn Mallory, MD, Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00192270
- Sponsor's protocol ID
- D153-P503
- Acronym
- FluMist
- Status last verified
- Mar 2012
- First submitted
- 12 Sep 2005
- Last updated
- 6 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label, Phase II, Multi-center Study of the Safety, Tolerability and Immunogenicity of Influenza Virus Vaccine, Trivalent, Types A and B, Live Cold-adapted (CAIV-T) in Healthy Children, Aged 6 to 17 Years
- ClinicalTrials.gov ID
- NCT00192270
- Acronym / sponsor ID
- FluMist / D153-P503
- Conditions
- Healthy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 498 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Study start
- Oct 2000
- Primary completion
- Jan 2001 (actual)
- Study completion
- Jan 2001 (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.
The study was designed to determine the number of doses of CAIV-T required to effectively immunize children and adolescents in the 6 to 17 year age group.
Detailed description
This was a phase II, prospective, open-label, multicenter, outpatient study designed to evaluate the safety, tolerability, and immunogenicity of one or two doses of CAIV-T in children and adolescents between 6 and 17 years of age. Subjects were allocated to one of three study groups according to age at the time of enrollment: study group one consisted of subjects between 6 and 9 years of age, group two of subjects 10 to 12 years of age, and group three of subjects 13 to 17 years of age.
Approximately 450 subjects (ie, 150 subjects per age group) participated in the study and were scheduled to receive two intranasal doses of CAIV-T separated by 35 ± 7 days in an open-label manner.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cold-adapted influenza vaccine trivalent (CAIV-T) | Experimental | Biological: CAIV-TAll subjects were scheduled to receive 2 doses of CAIV-T.The total volume of 0.2 mL was administered intranasally with a spray applicator (approximately 0.1 mL into each nostril). |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- who are at least 6 years and not more than 17 years of age at the time of enrollment;
- who, if female and is post-menarche, has provided a negative pregnancy test; · who are in good health as determined by medical history, physical examination and clinical judgement;
- who have provided written informed consent (as appropriate and according to national guidelines) and whose parent(s) or legal guardian(s) have provided written informed consent after the nature of the study has been explained; 13 who, along with their parent(s) or legal guardian(s), will be available for duration of the study (approximately three months);
- who, together with their parent(s) or legal guardian(s), can be reached by study staff for the post-vaccination contacts [telephone, clinic visit or home visit].
Key exclusion criteria (15 listed)
- who are perceived to be unavailable or difficult to contact for evaluation or study visits during the study period and whose parent(s) or legal guardian(s) 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-TAlso: FluMistEach dose of the vaccine was formulated to contain approximately 1 x 10^7 TCID50 of each of three (two subtype A and one subtype B) reassortant 6:2 influenza strains, as described above, for a total of ~3 x 10^7 TCID50 per dose. | Biological | Cold-adapted influenza vaccine trivalent (CAIV-T) |
Primary outcome
The number of subjects achieving strain-specific hemagglutination inhibition (HAI) antibody seroconversion post Dose 1
Time frame: Day 0, Day 35 post Dose 1
Immunogenicity was evaluated by comparison of pre and post-vaccination strain-specific titers of serum HAI antibody. Seroconversion was defined as a four-fold or greater rise in serum HAI antibody titer.
4 secondary outcomes
The number of subjects achieving strain-specific HAI antibody seroconversion post Dose 1
Time frame: Day 0, Day 35 post Dose 2
The number of subjects reporting any reactogenicity event post dose
Time frame: Days 0-10
The number of subjects reporting any adverse event post dose
Time frame: Days 0-10
The number of subjects reporting serious adverse events post dose
Time frame: Days 0-42
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 6 Mar 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.
Raburn Mallory, MD study director
MedImmune LLC
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CAIV-T in people with Healthy, run by MedImmune LLC at 3 sites in 2 countries.
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 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 6 Mar 2012. 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 Belgium, 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 achieving strain-specific hemagglutination inhibition (HAI) antibody seroconversion post Dose 1 (time frame: Day 0, Day 35 post Dose 1). 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 6 Mar 2012.