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

December 5, 2008 updated by: MedImmune LLC

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 229899
        • Respiratory Medicine Service

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

11 months to 2 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MedImmune LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lucy Chai-See Lum, Prof., University of Malaya Medical Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2002

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2003

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2003

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 12, 2005

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2005

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 8, 2008

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2008

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D153-P522

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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