NCT00217230

Brief Summary

The purpose of this study is to determine the efficacy, safety and tolerability of the liquid formulation of CAIV-T against culture confirmed influenza illness in adults aged 60 years and older. In addition this study aims to demonstrate superiority of CAIV-T when compared with placebo and the effect on economic resources.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,000

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Apr 2001

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2001

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 22, 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

Influenza

Outcome Measures

Primary Outcomes (1)

  • The primary study endpoint was the comparison of efficacy of CAIV-T versus placebo against culture-confirmed influenza-illness caused by community-acquired influenza subtypes that were antigenically similar to those contained in the vaccine.

Secondary Outcomes (1)

  • A secondary comparison of interest was the incidence of culture-confirmed influenza-illness caused by any antigenic subtype.

Interventions

CAIV-TBIOLOGICAL

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • who are and aged at least 60 years or older at the time of enrollment;
  • who are determined by medical history, physical examination and clinical judgement to be eligible for this study. Subjects with stable pre-existing disease, defined as disease not requiring change in therapy or hospitalization within 12 weeks before receipt of study vaccination will be eligible.
  • who have provided written informed consent after the nature of the study has been explained;
  • who, will be available for duration of the trial (from enrollment to approximately November 30, 2001); who can be reached by study staff for the post-vaccination and weekly surveillance contacts \[telephone, clinic or home visit\].

You may not qualify if:

  • who are perceived to be unavailable or difficult to contact for evaluation or study visits during the study period;
  • who are a resident of a nursing home or long-term care facility or other institution receiving skilled or semi-skilled nursing care (refer to study manual). An ambulatory subject who is a resident of a retirement home or village is eligible for the trial.
  • With evidence of dementia or other severe cognitive impairment based on Mini Mental State Examination (MMSE) scores (refer to study manual).
  • with a known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids; or cytotoxic agents;
  • who received any blood products, including immunoglobulin, in the period from six months prior to vaccination through to the conclusion of the study;
  • have an immunosuppressed or an immunocompromised individual living in the same household;
  • with a documented history of hypersensitivity to egg or egg protein or any other component of the study vaccine or placebo;
  • who were administered any live virus vaccine within one month prior to enrollment or expected to receive another live virus vaccine within one month of vaccination in this study;
  • for whom there is intent to administer any other investigational vaccine or agent from one month prior to enrollment through to the conclusion of the study;
  • who, received a dose of influenza treatment (commercial or investigational) one month prior to enrollment. The prophylactic use of influenza antivirals is not permitted.
  • who receive any influenza vaccine in the 6 months to enrollment, or a non-study influenza vaccine since enrollment;
  • with any medical conditions that in the opinion of the investigator might interfere with interpretation of the study results; Note: A pregnant household member is not considered a contraindication to enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Family & Primary Care, Faculty of Medicine, University of Stellenbosch

Tygerberg, 7505, South Africa

Location

Related Publications (1)

  • De Villiers PJ, Steele AD, Hiemstra LA, Rappaport R, Dunning AJ, Gruber WC, Forrest BD; LAIV Elderly Study Trial Network. Efficacy and safety of a live attenuated influenza vaccine in adults 60 years of age and older. Vaccine. 2009 Dec 10;28(1):228-34. doi: 10.1016/j.vaccine.2009.09.092. Epub 2009 Sep 29.

    PMID: 19796721DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

FluMist

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Pjt de Villiers, Professor

    Dept of Family Medicine & Primary Care, University of Stellenbosch

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 22, 2005

Study Start

April 1, 2001

Study Completion

November 1, 2001

Last Updated

October 3, 2006

Record last verified: 2006-10

Locations

ZA(1)