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

Respiratory Tract Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00192205
• Other study ID #: D153-P514
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: October 2, 2006
• Start date: October 2002
• Est. completion date: June 2003

Study information

• Verified date: October 2006
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2200
• Est. completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 71 Months

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Respiratory Tract Infections

Intervention

Biological:
• CAIV-T or TIV

Locations

Country	Name	City	State
Israel	Schneider Children's Medical Center of Israel	Petah-Tikva
Spain	Hospital de Txagorritxu	Vitoria

Sponsors (2)

Lead Sponsor	Collaborator
MedImmune LLC	Wyeth is now a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

Israel,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	To demonstrate that the efficacy of CAIV-T is not inferior to that of TIV against clinically-defined acute otitis media
Secondary	To compare the rate of occurence over a defined surveillance period in children with a histroy of recurrent RTIs