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Trial to Compare the Safety,Tolerability and Efficacy of Influenza Virus Vaccine, (CAIV-T) With Influenza Virus Vaccine, Trivalent, Inactivated (TIV) in Children

Primary Purpose

Respiratory Tract Infections

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
CAIV-T or TIV
Sponsored by
MedImmune LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Tract Infections

Eligibility Criteria

6 Months - 71 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: who are aged at least 6 months and less than 72 months of age at the time of enrolment; who have experienced two or more practitioner attended RTIs* in the past 12 months (since birth if less than 12 months old); * RTIs are defined as upper RTIs including (but not limited to) common cold, acute otitis media and lower RTIs including (but not limited to) bronchiolitis, bronchitis and pneumonia. 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; whose parent(s)/legal guardian(s), can be reached by study staff for the post-vaccination contacts [telephone, clinic or home visit]. Exclusion Criteria: 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 of a dose equivalent to (i) 2mg/kg/day or greater of Prednisolone or (ii) equivalent to a total of 20 mg/day or greater for children who weigh more than 10kg, for more than 14 days duration until 2 weeks after corticosteroids have been discontinued 27; 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 enrolment through to the conclusion of the study; who 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) or is anticipated to receive a non-study influenza vaccine after enrollment; with a documented history of hypersensitivity to egg or egg protein or any other component of CAIV-T or TIV; who received aspirin (acetylsalicylic acid) or aspirin-containing products in the two weeks prior to enrolment 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; Note: Pregnancy in any person who has regular contact with the subject is not a contraindication to the enrolment or ongoing participation of the subject in the study.

Sites / Locations

  • Schneider Children's Medical Center of Israel
  • Hospital de Txagorritxu

Outcomes

Primary Outcome Measures

To demostrate that the efficacy over one season against culture-confirmed influenza-illness caused by community-acquired subtypes antigenically similar to those contained in the vaccine

Secondary Outcome Measures

To demostrate that the efficacy over one season of CAIV-T is not inferior to that of TIV against culture-confirmed influenza-illness of any subtype
To demonstrate that the efficacy of CAIV-T is not inferior to that of TIV against clinically-defined acute otitis media
To compare the rate of occurence over a defined surveillance period in children with a histroy of recurrent RTIs

Full Information

First Posted
September 12, 2005
Last Updated
October 2, 2006
Sponsor
MedImmune LLC
Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00192205
Brief Title
Trial to Compare the Safety,Tolerability and Efficacy of Influenza Virus Vaccine, (CAIV-T) With Influenza Virus Vaccine, Trivalent, Inactivated (TIV) in Children
Official Title
A Prospective, Randomized, Open-Label, Controlled Trial to Compare the Safety, Tolerability and Efficacy of Influenza Virus Vaccine, Trivalent, Type A&B, Live, Cold-Adapted (CAIV-T) With Influenza Virus Vaccine, Trivalent, Inactivated (TIV) in Children With a History of Recurrent Respiratory Tract Infections Aged 6 Months to Less Than 72 Months
Study Type
Interventional

2. Study Status

Record Verification Date
October 2006
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
MedImmune LLC
Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

5. Study Description

Brief Summary
- Trial to compare the efficacy of the liquid formulation of CAIV-T with TIV against culture confirmed influenza illness in children.
Detailed Description
The purpose of this study is to compare the efficacy of the liquid formulation of CAIV-T with TIV against culture confirmed influenza illness in children with a history of recurrent RTIs aged at least 6 months and less than 72 months of age. The trial also provides the opportunity to compare the efficacy of CAIV-T with TIV on acute otitis media.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Tract Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2200 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
CAIV-T or TIV
Primary Outcome Measure Information:
Title
To demostrate that the efficacy over one season against culture-confirmed influenza-illness caused by community-acquired subtypes antigenically similar to those contained in the vaccine
Secondary Outcome Measure Information:
Title
To demostrate that the efficacy over one season of CAIV-T is not inferior to that of TIV against culture-confirmed influenza-illness of any subtype
Title
To demonstrate that the efficacy of CAIV-T is not inferior to that of TIV against clinically-defined acute otitis media
Title
To compare the rate of occurence over a defined surveillance period in children with a histroy of recurrent RTIs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
71 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: who are aged at least 6 months and less than 72 months of age at the time of enrolment; who have experienced two or more practitioner attended RTIs* in the past 12 months (since birth if less than 12 months old); * RTIs are defined as upper RTIs including (but not limited to) common cold, acute otitis media and lower RTIs including (but not limited to) bronchiolitis, bronchitis and pneumonia. 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; whose parent(s)/legal guardian(s), can be reached by study staff for the post-vaccination contacts [telephone, clinic or home visit]. Exclusion Criteria: 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 of a dose equivalent to (i) 2mg/kg/day or greater of Prednisolone or (ii) equivalent to a total of 20 mg/day or greater for children who weigh more than 10kg, for more than 14 days duration until 2 weeks after corticosteroids have been discontinued 27; 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 enrolment through to the conclusion of the study; who 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) or is anticipated to receive a non-study influenza vaccine after enrollment; with a documented history of hypersensitivity to egg or egg protein or any other component of CAIV-T or TIV; who received aspirin (acetylsalicylic acid) or aspirin-containing products in the two weeks prior to enrolment 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; Note: Pregnancy in any person who has regular contact with the subject is not a contraindication to the enrolment or ongoing participation of the subject in the study.
Facility Information:
Facility Name
Schneider Children's Medical Center of Israel
City
Petah-Tikva
Country
Israel
Facility Name
Hospital de Txagorritxu
City
Vitoria
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

Trial to Compare the Safety,Tolerability and Efficacy of Influenza Virus Vaccine, (CAIV-T) With Influenza Virus Vaccine, Trivalent, Inactivated (TIV) in Children

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