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

Last updated date
Study Location
Respiratory Medicine Service
Singapore, , 229899, Singapore
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Influenza
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
11-24 months
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Advanced Information
Descriptive Information
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
  • 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  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
 (submitted: September 12, 2005)
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:

  • 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.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Principal Investigator:Lucy Chai-See Lum, Prof.University of Malaya Medical Centre
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