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
NCT00192166
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- 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)
- 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.
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Descriptive Information | ||||
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Brief Title ICMJE | 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 | |||
Official Title ICMJE | 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 | |||
Brief 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. | |||
Detailed Description |
| |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double Primary Purpose: Prevention | |||
Condition ICMJE | Influenza | |||
Intervention ICMJE | Biological: CAIV-T | |||
Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE | 1200 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | May 2003 | |||
Actual Primary Completion Date | March 2003 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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. | |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 11 Months to 24 Months (Child) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Singapore | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00192166 | |||
Other Study ID Numbers ICMJE | D153-P522 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | MedImmune LLC | |||
Collaborators ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Investigators ICMJE |
| |||
PRS Account | MedImmune LLC | |||
Verification Date | December 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |