HealthyPhase 3NCT00192400

Trial to Assess the Safety and Tolerability of the Liquid Formulation of CAIV-T in Healthy Children.

A Phase 3 study testing CAIV-T in people with Healthy, run by MedImmune LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to determine the efficacy of the liquid formulation of CAIV-T against culture confirmed influenza illness in healthy children aged at least 6 months and less than 36 months. Read more about this study

Who is it for?: Ages 6 to 35 monthsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: CAIV-T
How many people: 2,160 participants
Where: No sites listed yet
Study dates: Mar 2002to Nov 2002
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 35 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

who is aged at least 6 months and less than 36 months of age at the time of enrollment;
who is 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 until the completion of the first season's surveillance phase;
whose parent(s)/legal guardian(s), can be reached by study staff for the post-vaccination contacts [telephone, clinic or home visit].
(Second Season)

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who was enrolled into the first season of the trial and received at least one vaccination in the primary series;
who completed the safety and efficacy evaluations during the first season surveillance phase;
who is in good health as determined by medical history, physical examination and clinical judgement;
whose parent(s)/legal guardian(s) have provided written informed consent for the second season of the trial after the nature of the study has been explained;
who, along with their parent(s)/legal guardian(s), will be available until the completion of the second season's surveillance phase;
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;
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;

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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);
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 assigned 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 expected to receive 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: 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.
(Second Season)
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 corticosteroid of a dose equivalent to 2 mg/kg/day or greater of prednisolone or equivalent to a total of 20 mg/day or greater for children who weigh more than 10 kg, for more than 14 days duration until 2 weeks after corticosteroids have been discontinued;
who received any blood products, including immunoglobulin, in the period from six months prior to the second season 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 the second season vaccination through to the conclusion of the study;
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 the exception of the primary series of study vaccine (CAIV-T/placebo);
who, in the two weeks prior to receiving the second season vaccination, 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 assigned study vaccine (CAIV-T/placebo);
with a clinically confirmed respiratory illness with wheezing within two weeks prior to receiving the second season vaccination;
who received aspirin (acetylsalicylic acid) or aspirin-containing products in the two weeks prior to receiving the second season vaccination or for which use is anticipated during the study;
who were administered any live virus vaccine within one month prior to receiving the second season vaccination or expected to receive another live virus vaccine within one month of receiving the second season vaccination;
with any medical conditions that in the opinion of the investigator might interfere with interpretation of the study results.
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, Double-Blind, Placebo-Controlled Trial to Compare the Safety, Tolerability, Immunogenicity and Efficacy of One Dose and Two Doses of a Liquid Formulation of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (CAIV-T) Compared With Placebo in Healthy Children

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

What is being measured

The primary outcome is the main question the study is designed to answer.

The primary endpoint for efficacy is the first episode in the first season in a study child of a culture-confirmed influenza illness, caused by community-acquired subtypes antigenically similar to those contained in the vaccine.

Secondary outcomes (1)

The first episode in the second season in a study child of a culture-confirmed influenza illness, caused by community-acquired subtypes antigenically similar to those contained in the vaccine.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2002Nov 2002

First posted19 Sep 2005 (estimated)
Study startMar 2002
Study completionNov 2002

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 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 3
Primary purpose: Early clinical test
Allocation: Randomised
Intervention model: Single group
Masking: Double blind
Enrolment: 2,160 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00192400
Sponsor's protocol ID: D153-P504
Status last verified: Oct 2006
First submitted: 13 Sep 2005
Last updated: 3 Oct 2006
Results posted: No

Publications

Bracco Neto H, Farhat CK, Tregnaghi MW, Madhi SA, Razmpour A, Palladino G, Small MG, Gruber WC, Forrest BD; D153-P504 LAIV Study Group. Efficacy and safety of 1 and 2 doses of live attenuated influenza vaccine in vaccine-naive children. Pediatr Infect Dis J. 2009 May;28(5):365-71. doi: 10.1097/INF.0b013e31819219b8.
PubMed 19395948

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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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, Double-Blind, Placebo-Controlled Trial to Compare the Safety, Tolerability, Immunogenicity and Efficacy of One Dose and Two Doses of a Liquid Formulation of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (CAIV-T) Compared With Placebo in Healthy Children
ClinicalTrials.gov ID: NCT00192400
Acronym / sponsor ID: D153-P504
Conditions: Healthy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,160 participants
Lead sponsor: MedImmune LLCIndustry (pharma, biotech, devices)
Collaborators: Wyeth is now a wholly owned subsidiary of Pfizer
Study start: Mar 2002
Study completion: Nov 2002
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.

Study design

Primary purpose: Early clinical test
Allocation: Randomised
Intervention model: Single group
Masking: Double blind

Who may qualify

Ages: 6 to 35 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (12 listed)

who is aged at least 6 months and less than 36 months of age at the time of enrollment;
who is 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 until the completion of the first season's surveillance phase;
whose parent(s)/legal guardian(s), can be reached by study staff for the post-vaccination contacts [telephone, clinic or home visit].

Key exclusion criteria (32 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;
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 for efficacy is the first episode in the first season in a study child of a culture-confirmed influenza illness, caused by community-acquired subtypes antigenically similar to those contained in the vaccine.

1 secondary outcome

The first episode in the second season in a study child of a culture-confirmed influenza illness, caused by community-acquired subtypes antigenically similar to those contained in the vaccine.

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.
Derived from this study: PubMed 19395948Bracco Neto H, Farhat CK, Tregnaghi MW, Madhi SA, Razmpour A, Palladino G, Small MG, Gruber WC, Forrest BD; D153-P504 LAIV Study Group. Efficacy and safety of 1 and 2 doses of live attenuated influenza vaccine in vaccine-naive children. Pediatr Infect Dis J. 2009 May;28(5):365-71. doi: 10.1097/INF.0b013e31819219b8.

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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 Healthy, 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 12 inclusion and 32 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 endpoint for efficacy is the first episode in the first season in a study child of a culture-confirmed influenza illness, caused by community-acquired subtypes 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?

On the ClinicalTrials.gov record for NCT00192400, 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 3 Oct 2006.