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

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

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

Study Overview

• Status: Completed
• Conditions: Respiratory Tract Infections
• Intervention / Treatment: Biological: CAIV-T or TIV

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.

• Study Type: Interventional
• Enrollment: 2200
• Phase: Phase 3

Contacts and Locations

Study Locations

• Israel
  • Petah-Tikva, Israel
    • Schneider Children's Medical Center of Israel
• Spain
  • Vitoria, Spain
    • Hospital de Txagorritxu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

• Sponsor: MedImmune LLC
• Collaborators: Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

Study Major Dates

• Study Start: October 1, 2002
• Study Completion: June 1, 2003

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 19, 2005

Study Record Updates

• Last Update Posted (Estimate): October 3, 2006
• Last Update Submitted That Met QC Criteria: October 2, 2006
• Last Verified: October 1, 2006

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Orthomyxoviridae Infections; Infections; Influenza, Human; Respiratory Tract Infections
• Other Study ID Numbers: D153-P514