NCT00192205

Brief Summary

\- Trial to compare the efficacy of the liquid formulation of CAIV-T with TIV against culture confirmed influenza illness in children.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,200

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2002

Shorter than P25 for phase_3

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
Last Updated

October 3, 2006

Status Verified

October 1, 2006

First QC Date

September 12, 2005

Last Update Submit

October 2, 2006

Conditions

Respiratory Tract Infections

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Interventions

CAIV-T or TIVBIOLOGICAL

Eligibility Criteria

Age6 Months - 71 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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 \[telephone, clinic or home visit\].

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Schneider Children's Medical Center of Israel

Petah Tikva, Israel

Location

Hospital de Txagorritxu

Vitoria-Gasteiz, Spain

Location

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

October 1, 2002

Study Completion

June 1, 2003

Last Updated

October 3, 2006

Record last verified: 2006-10

Locations

ES(1)IL(1)