InfluenzaPhase 2NCT00192166
Trial to Assess Safety, Efficacy, Tolerability and Immunogenicity of Influenza Virus Vaccine, Liquid Formulation (CAIV-T), Administered Concomitantly With a Combination Live, Attenuated, Mumps, Measles, and Rubella Vaccine in Healthy Children Aged 11 - 24 Months
A Phase 2 study testing CAIV-T in people with Influenza, run by MedImmune LLC at 1 site in Singapore.
Trial summary
The primary objective of the study was to determine if intranasally administered influenza virus vaccine, CAIV-T), when administered concomitantly with a subcutaneously administered combination live, attenuated mumps, measles, and rubella (MMR) virus vaccine to children interferes with the immune responses. Read more about this study
- Who is it for?
- Ages 11 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- CAIV-T
- How many people
- 1,200 participants
- Where
- 1 siteSingapore
- Study dates
- Oct 2002to May 2003
- 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 11 to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- who were at least 11 months of age and less than 24 months of age at the time of first vaccination
- who were due to receive their first dose of combined measles, mumps, and rubella vaccine (MMR)
- who were in good health as determined by medical history, physical examination and clinical judgment
- whose parent(s)/legal guardian(s) provided written informed consent after the nature of the study was explained
- who, along with their parent(s)/legal guardian(s), were available for duration of the trial (approximately 8 months)
- whose parent(s)/legal guardian(s), could be reached by study staff for the post-vaccination contact (telephone, clinic or home visit)
Who cannot join
- whose parent(s)/legal guardian(s) were perceived to be unavailable or difficult to contact for evaluation or study visits during the study period
- who had any serious chronic disease (eg, with signs of cardiac or renal failure or severe malnutrition), including progressive neurological disease
- who had Down's syndrome or other known cytogenetic disorders who had a known or suspected disease of the immune system or those who received immunosuppressive therapy, including systemic corticosteroids. Subjects receiving high doses of systemic corticosteroids given daily or on alternate days, for 14 days or more, were excluded from vaccination until corticosteroid therapy was discontinued for at least one month. High doses were defined as 2 mg/kg/day or more of prednisolone or its equivalent, or 20 mg/day or more for children who weighed more than 10 kg.38
- who received, or were anticipated to receive, any blood products, including immunoglobulin, in the period from 6 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 had an immunosuppressed or an immunocompromised 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)
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- who, at any time prior to entry into this study, received a dose of MMR vaccine or any of the individual components of the MMR vaccine (commercial or investigational)
- who were anticipated to receive a subsequent dose of MMR within 1 month after receipt of the second dose of CAIV-T or placebo
- with a documented history of hypersensitivity to egg or egg protein or any other components of CAIV-T or MMR
- who received aspirin (acetylsalicylic acid) or aspirin-containing products in the 2 weeks prior to vaccination or for which use is anticipated during the study
- with any medical conditions that in the opinion of the Investigator might have interfered with interpretation of the study results
- Note: Pregnancy in any person who had regular contact with the subject was not a contraindication to the enrollment or ongoing participation of the subject in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trial to Assess Safety, Efficacy, Tolerability and Immunogenicity of Influenza Virus Vaccine, Administered Concomitantly With a Combination Live, Attenuated, Mumps, Measles, and Rubella Vaccine in Healthy Children Aged 11 - 24 Months
- The primary objective of the study was to determine if intranasally administered influenza virus vaccine, CAIV-T), when administered concomitantly with a subcutaneously administered combination live, attenuated mumps, measles, and rubella (MMR) virus vaccine to children interferes with the immune responses.
Read the detailed description
- The primary objective of the study was to determine if intranasally administered influenza virus vaccine, trivalent, types A and B, live, cold-adapted (CAIV-T), when administered concomitantly with a subcutaneously administered combination live, attenuated mumps, measles, and rubella (MMR) virus vaccine to children aged 11 to less than 24 months, interferes with the immune responses to the measles, mumps, and rubella components of the MMR vaccine.
- To compare the efficacy over one season against culture-confirmed influenza-illness caused by community-acquired subtypes antigenically similar to those contained in the vaccine, in children who are aged at least 11 months and less than 24 months at enrollment, between those who receive two doses of CAIV-T and those who receive placebo, each with concomitant administration of a combination live, attenuated MMR vaccine administered prior to the anticipated commencement of the influenza season.
- 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.
All episodes of AOM, occurring during the influenza season, associated with a positive culture for influenza virus antigenically similar to those contained in the vaccine.
Secondary outcomes (1)
The first episode during the influenza season of AOM associated with a positive culture for influenza virus; all episodes during the influenza season of AOM; all during the influenza season, of AOM associated with fever.
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 2002
- Primary completionMar 2003
- Study completionMay 2003
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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 1,200 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
- Lucy Chai-See Lum, Prof., Principal investigator, University of Malaya Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00192166
- Sponsor's protocol ID
- D153-P522
- Status last verified
- Dec 2008
- First submitted
- 12 Sep 2005
- Last updated
- 8 Dec 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial to Assess Safety, Efficacy, Tolerability and Immunogenicity of Influenza Virus Vaccine, Administered Concomitantly With a Combination Live, Attenuated, Mumps, Measles, and Rubella Vaccine in Healthy Children Aged 11 - 24 Months
- ClinicalTrials.gov ID
- NCT00192166
- Acronym / sponsor ID
- D153-P522
- Conditions
- Influenza
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Study start
- Oct 2002
- Primary completion
- Mar 2003 (actual)
- Study completion
- May 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.
- The primary objective of the study was to determine if intranasally administered influenza virus vaccine, CAIV-T), when administered concomitantly with a subcutaneously administered combination live, attenuated mumps, measles, and rubella (MMR) virus vaccine to children interferes with the immune responses.
Detailed description
- The primary objective of the study was to determine if intranasally administered influenza virus vaccine, trivalent, types A and B, live, cold-adapted (CAIV-T), when administered concomitantly with a subcutaneously administered combination live, attenuated mumps, measles, and rubella (MMR) virus vaccine to children aged 11 to less than 24 months, interferes with the immune responses to the measles, mumps, and rubella components of the MMR vaccine.
- To compare the efficacy over one season against culture-confirmed influenza-illness caused by community-acquired subtypes antigenically similar to those contained in the vaccine, in children who are aged at least 11 months and less than 24 months at enrollment, between those who receive two doses of CAIV-T and those who receive placebo, each with concomitant administration of a combination live, attenuated MMR vaccine administered prior to the anticipated commencement of the influenza season.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 11 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- who were at least 11 months of age and less than 24 months of age at the time of first vaccination
- who were due to receive their first dose of combined measles, mumps, and rubella vaccine (MMR)
- who were in good health as determined by medical history, physical examination and clinical judgment
- whose parent(s)/legal guardian(s) provided written informed consent after the nature of the study was explained
- who, along with their parent(s)/legal guardian(s), were available for duration of the trial (approximately 8 months)
Key exclusion criteria (12 listed)
- whose parent(s)/legal guardian(s) were perceived to be unavailable or difficult to contact for evaluation or study visits during the study period
- who had any serious chronic disease (eg, with signs of cardiac or renal failure or severe malnutrition), including progressive neurological disease
- who had Down's syndrome or other known cytogenetic disorders who had a known or suspected disease of the immune system or those who received immunosuppressive therapy, including systemic corticosteroids. Subjects receiving high doses of systemic corticosteroids given daily or on alternate days, for 14 days or more, were excluded from vaccination until corticosteroid therapy was discontinued for at least one month. High doses were defined as 2 mg/kg/day or more of prednisolone or its equivalent, or 20 mg/day or more for children who weighed more than 10 kg.38
- who received, or were anticipated to receive, any blood products, including immunoglobulin, in the period from 6 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 had an immunosuppressed or an immunocompromised individual living in the same household
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
All episodes of AOM, occurring during the influenza season, associated with a positive culture for influenza virus antigenically similar to those contained in the vaccine.
1 secondary outcome
The first episode during the influenza season of AOM associated with a positive culture for influenza virus; all episodes during the influenza season of AOM; all during the influenza season, of AOM associated with fever.
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 Dec 2008.
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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.
Lucy Chai-See Lum, Prof. principal investigator
University of Malaya Medical Centre
1 site in 1 country: 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 Influenza, run by MedImmune LLC at 1 site in Singapore.
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 12 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 Dec 2008. 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 Singapore. 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?
All episodes of AOM, occurring during the influenza season, associated with a positive culture for influenza virus antigenically similar to those contained in the vaccine.. 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 8 Dec 2008.