InfluenzaPhase 3NCT00192491
Trial to Assess Safety, Tolerability, and Immunogenicity of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (FluMist) and Measles, Mumps, Rubella, and Varicella Vaccines Administered Concurrently to Healthy Children
A Phase 3 study testing FluMist in people with Influenza, run by MedImmune LLC.
Trial summary
To compare immune responses to measles, mumps, rubella, and varicella antigens following vaccination in children who receive FluMist concurrently with MMRIIÒ and VARIVAXÒ and in children who receive an intranasal placebo mist concurrently with MMRIIÒ and VARIVAXÒ (Group 2 vs. Group 1). Read more about this study
- Who is it for?
- Ages 12 to 15 monthsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- FluMist
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,200 participants
- Where
- No sites listed yet
- Study dates
- Dec 2000to Dec 2003
- 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 12 to 15 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 12 to 15 months of age (not reached their 16th month birthday);
- In good health;
- Parent/guardian available by telephone or for home visits;
- Ability of the parent/guardian to understand and comply with the requirements of the protocol;
- Signed informed consent by parent/guardian; and
- Up to date with the primary series of recommended vaccines per standard clinic practice and local vaccine availability.
Who cannot join
- Previous known measles, mumps, rubella or varicella disease;
- Previous vaccination against measles, mumps, rubella or varicella disease;
- Hypersensitivity to egg or egg protein;
- Signs or symptoms of any immunosuppressive or immune deficiency disease or ongoing immunosuppressive therapy; or an immunosuppressed individual living in the same household;
- Acute febrile (>100.0oF [37.8°C] oral) illness or clinically significant upper respiratory illness within the 72 hours prior to enrollment;
- Use of aspirin (acetylsalicylic acid) or aspirin-containing products in the month prior to enrollment, or expected use of aspirin while enrolled in this study;
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- Administration of any intranasal medication within two weeks prior to enrollment or expected receipt during this study;
- Administration of any live virus vaccine within one month prior to enrollment through 30 days after Visit 3;
- Administration of any inactivated vaccine within two weeks prior to enrollment through 30 days after Visit 3;
- Participation in another investigational trial within one month prior to enrollment or expected enrollment in another investigational trial during this study;
- Receipt of any blood product within three months prior to vaccination or expected receipt within the study duration; and
- Any condition which, in the opinion of the investigator, would interfere with the interpretation or evaluation of the vaccines.
- History of two or more episodes of medically attended wheezing illness by parent/guardian report.
- History of medically attended wheezing illness or bronchodilator medication use within four weeks of enrollment by parent/guardian report.
About this study
Official title: A Randomized, Placebo-Controlled, Trial to Assess Safety, Tolerability, and Immunogenicity of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (FluMist) and Measles, Mumps, Rubella, (MMRIIÒ) and Varicella (VARIVAXÒ) Vaccines Administered Concurrently to Healthy Children (AV018)
- To compare immune responses to measles, mumps, rubella, and varicella antigens following vaccination in children who receive FluMist concurrently with MMRIIÒ and VARIVAXÒ and in children who receive an intranasal placebo mist concurrently with MMRIIÒ and VARIVAXÒ (Group 2 vs. Group 1).
- To compare immune responses to the three strains of influenza (H1N1, H3N2, and B) following a two dose regimen of FluMist in children who receive the initial FluMist dose concurrently with MMRIIÒ and VARIVAXÒ and in children who receive two doses of FluMist alone (Group 2 vs. Group 3).Secondary:
- To assess the safety and tolerability of concurrent administration of FluMist with MMRIIÒ and VARIVAXÒ.
- Conditions
- Influenza
- Being tested
- FluMist, Placebo
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluMistBiological
Nasal Sprayer of one dosage of FluMist and other experimental
FluMistBiological
Nasal sprayer of FluMist
PlaceboOther
Nasal Sprayer of Placebo
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | FluMist Receives: Biological: FluMist |
| 3 | Placebo comparator | Placebo Receives: Other: Placebo |
| 1 | Active comparator | FluMist with other solution Receives: Biological: FluMist |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare immune responses to measles, mumps, rubella, and varicella antigens following vaccination in children who receive FluMist concurrently with MMRIIÒ and VARIVAXÒ and in children
Measured: Day 42
Secondary outcomes (1)
Compare immune responses to the three strains of influenza (H1N1, H3N2, and B) following a two dose regimen of FluMist in children who receive the initial FluMist
Measured: Day 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 startDec 2000
- Primary completionSep 2003 (estimated)
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Robert Walker, M.D., Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00192491
- Sponsor's protocol ID
- AV018
- Status last verified
- Feb 2008
- First submitted
- 12 Sep 2005
- Last updated
- 8 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Nolan T, Bernstein DI, Block SL, Hilty M, Keyserling HL, Marchant C, Marshall H, Richmond P, Yogev R, Cordova J, Cho I, Mendelman PM; LAIV Study Group. Safety and immunogenicity of concurrent administration of live attenuated influenza vaccine with measles-mumps-rubella and varicella vaccines to infants 12 to 15 months of age. Pediatrics. 2008 Mar;121(3):508-16. doi: 10.1542/peds.2007-1064.
PubMed 18310199
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Trial to Assess Safety, Tolerability, and Immunogenicity of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (FluMist) and Measles, Mumps, Rubella, (MMRIIÒ) and Varicella (VARIVAXÒ) Vaccines Administered Concurrently to Healthy Children (AV018)
- ClinicalTrials.gov ID
- NCT00192491
- Acronym / sponsor ID
- AV018
- Conditions
- Influenza
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2000
- Primary completion
- Sep 2003 (estimated)
- Study completion
- Dec 2003 (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.
- To compare immune responses to measles, mumps, rubella, and varicella antigens following vaccination in children who receive FluMist concurrently with MMRIIÒ and VARIVAXÒ and in children who receive an intranasal placebo mist concurrently with MMRIIÒ and VARIVAXÒ (Group 2 vs. Group 1).
- To compare immune responses to the three strains of influenza (H1N1, H3N2, and B) following a two dose regimen of FluMist in children who receive the initial FluMist dose concurrently with MMRIIÒ and VARIVAXÒ and in children who receive two doses of FluMist alone (Group 2 vs. Group 3).Secondary:
- To assess the safety and tolerability of concurrent administration of FluMist with MMRIIÒ and VARIVAXÒ.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Biological: FluMistFluMist |
| 3 | Placebo comparator | Other: PlaceboPlacebo |
| 1 | Active comparator | Biological: FluMistFluMist with other solution |
Who may qualify
- Ages
- 12 to 15 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 12 to 15 months of age (not reached their 16th month birthday);
- In good health;
- Parent/guardian available by telephone or for home visits;
- Ability of the parent/guardian to understand and comply with the requirements of the protocol;
- Signed informed consent by parent/guardian; and
Key exclusion criteria (14 listed)
- Previous known measles, mumps, rubella or varicella disease;
- Previous vaccination against measles, mumps, rubella or varicella disease;
- Hypersensitivity to egg or egg protein;
- Signs or symptoms of any immunosuppressive or immune deficiency disease or ongoing immunosuppressive therapy; or an immunosuppressed individual living in the same household;
- Acute febrile (>100.0oF [37.8°C] oral) illness or clinically significant upper respiratory illness within the 72 hours prior to enrollment;
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 |
|---|---|---|
| FluMistNasal Sprayer of one dosage of FluMist and other experimental | Biological | 1 |
| FluMistNasal sprayer of FluMist | Biological | 2 |
| PlaceboNasal Sprayer of Placebo | Other | 3 |
Primary outcome
compare immune responses to measles, mumps, rubella, and varicella antigens following vaccination in children who receive FluMist concurrently with MMRIIÒ and VARIVAXÒ and in children
Time frame: Day 42
1 secondary outcome
Compare immune responses to the three strains of influenza (H1N1, H3N2, and B) following a two dose regimen of FluMist in children who receive the initial FluMist
Time frame: Day 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 8 Feb 2008.
- Derived from this study: PubMed 18310199Nolan T, Bernstein DI, Block SL, Hilty M, Keyserling HL, Marchant C, Marshall H, Richmond P, Yogev R, Cordova J, Cho I, Mendelman PM; LAIV Study Group. Safety and immunogenicity of concurrent administration of live attenuated influenza vaccine with measles-mumps-rubella and varicella vaccines to infants 12 to 15 months of age. Pediatrics. 2008 Mar;121(3):508-16. doi: 10.1542/peds.2007-1064.
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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, M.D. study director
MedImmune LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FluMist in people with Influenza, 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 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 8 Feb 2008. 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 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?
compare immune responses to measles, mumps, rubella, and varicella antigens following vaccination in children who receive FluMist concurrently with MMRIIÒ and VARIVAXÒ and in children (time frame: Day 42). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00192491, which also lists 1 linked publication.
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 8 Feb 2008.