InfluenzaPhase 3NCT00192426
Trial to Evaluate the Immune Response to OPV When Administered Concomitantly With CAIV-T to Healthy Children.
A Phase 3 study testing CAIV-T in people with Influenza, run by MedImmune LLC.
Trial summary
Phase III trial to evaluate the immune response to oral poliovirus vaccine (OPV) when administered concomitantly with CAIV-T to healthy children. Read more about this study
- Who is it for?
- Ages 6 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- CAIV-T
- How many people
- 2,400 participants
- Where
- No sites listed yet
- Study dates
- Sep 2001to Dec 2001
- 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 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- who are aged at least 6 months and less than 36 months of age at the time of first vaccination
- who have received a full primary vaccination schedule consisting of three doses of OPV in the first year of life
- who are in good health as determined by medical history, physical examination and clinical judgement
- whose parent(s)/legal guardian(s) have provided written informed consent after the nature of the study has been explained
- who, along with their parent(s)/legal guardian(s), will be available for duration of the trial (3 months)
- whose parent(s)/legal guardian(s), can be reached by study staff for the post-vaccination contacts [telephone, clinic or home visit].
Who cannot join
- whose parent(s)/legal guardian(s) are perceived to be unavailable 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 (see Section 4.2.1)
- 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 13Show fewer
- have 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)
- with a documented history of hypersensitivity to egg or egg protein or any other component of the assigned study vaccine
- who received aspirin (acetylsalicylic acid) or aspirin-containing products in the two 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 interfere with interpretation of the study results.
- If any of these criteria are met following enrollment, the subject will be excluded from subsequent vaccine dosing.
- Note: Pregnancy in a household member or any person who has regular contact with the subject is not a contraindication to the enrollment or ongoing participation of the subject in the study.
About this study
Official title: A Prospective, Randomized, Partially-Blinded, Placebo-Controlled, Phase III, Multicenter Trial to Assess Safety, Tolerability and Immunogenicity of Liquid CAIV-T Administered Concomitantly With OPV in Healthy Children
Phase III trial to evaluate the immune response to oral poliovirus vaccine (OPV) when administered concomitantly with CAIV-T to healthy children.
- 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 immunogenicity endpoint is the proportion of subjects achieving a post-vaccination serum antibody response for each antigen component of OPV and CAIV-T.
Secondary outcomes (1)
The secondary endpoint for immunogenicity is the geometric mean titer (GMT) of serum antibody for each antigen component of OPV or the geometric mean ratio relative to the baseline titer of CAIV-T serum antibody components.
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 2001
- Study completionDec 2001
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
- Crossover
- Masking
- Double blind
- Enrolment
- 2,400 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
- NCT00192426
- Sponsor's protocol ID
- D153-P511
- Status last verified
- Oct 2006
- First submitted
- 13 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, Partially-Blinded, Placebo-Controlled, Phase III, Multicenter Trial to Assess Safety, Tolerability and Immunogenicity of Liquid CAIV-T Administered Concomitantly With OPV in Healthy Children
- ClinicalTrials.gov ID
- NCT00192426
- Acronym / sponsor ID
- D153-P511
- Conditions
- Influenza
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,400 participants
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Study start
- Sep 2001
- Study completion
- Dec 2001
- 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.
Phase III trial to evaluate the immune response to oral poliovirus vaccine (OPV) when administered concomitantly with CAIV-T to healthy children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 6 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- who are aged at least 6 months and less than 36 months of age at the time of first vaccination
- who have received a full primary vaccination schedule consisting of three doses of OPV in the first year of life
- who are in good health as determined by medical history, physical examination and clinical judgement
- whose parent(s)/legal guardian(s) have provided written informed consent after the nature of the study has been explained
- who, along with their parent(s)/legal guardian(s), will be available for duration of the trial (3 months)
Key exclusion criteria (13 listed)
- whose parent(s)/legal guardian(s) are perceived to be unavailable 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 (see Section 4.2.1)
- 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 immunogenicity endpoint is the proportion of subjects achieving a post-vaccination serum antibody response for each antigen component of OPV and CAIV-T.
1 secondary outcome
The secondary endpoint for immunogenicity is the geometric mean titer (GMT) of serum antibody for each antigen component of OPV or the geometric mean ratio relative to the baseline titer of CAIV-T serum antibody components.
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
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.
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 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.
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 immunogenicity endpoint is the proportion of subjects achieving a post-vaccination serum antibody response for each antigen component of OPV and CAIV-T.. 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.