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Trial to Compare the Safety, Tolerability, and Efficacy of Influenza Virus Vaccine, (CAIV-T) With Inactivated, Influenza Vaccine, Trivalent, Types A & B, in Adults Aged 60 Years and Older Against Culture-confirmed Influenza (FluMist)

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MedImmune

Status and phase

Completed
Phase 3

Conditions

Influenza

Treatments

Biological: Cold-adapted influenza vaccine trivalent (CAIV-T)
Biological: Trivalent Inactivated Vaccine (TIV)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00192413
D153-P516

Details and patient eligibility

About

To demonstrate that the efficacy over a defined surveillance period against culture-confirmed influenza-illness caused by community-acquired subtypes antigenically similar to those contained in the vaccine, in adults aged at least 60 years at enrollment, of a single intranasally (IN) -administered dose of a liquid formulation of influenza virus vaccine,(CAIV-T) is non inferior compared with that of a single dose of commercially available influenza vaccine inactivated (TIV) administered intramuscularly (IM) prior to the anticipated commencement of the influenza season.

Enrollment

3,009 patients

Sex

All

Ages

60+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • who are 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;
  • 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 November 30th, 2003);
  • who can be reached by study staff for the post-vaccination and weekly surveillance contacts [telephone, clinic or home visit].

Exclusion criteria

  • 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 Influenza study specific manual). An ambulatory subject who is a resident of a retirement home or village is eligible for the trial;
  • with any signs of renal insufficiency requiring supportive therapy or progressive neurological disease. (Subjects with other 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).
  • with evidence of dementia or other severe cognitive impairment based on Mini Mental State Examination (MMSE) scores (refer to Influenza study specific 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 CAIV-T or TIV vaccine;
  • who were administered any live virus vaccine within one month prior to vaccination 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 prior to enrollment, or intend to receive a non-study influenza vaccine after 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

3,009 participants in 2 patient groups

Cold-adapted influenza vaccine trivalent (CAIV-T)
Experimental group
Description:
A single 0.2 mL dose of 10\^7 fluorescent focus units was administered intranasally.
Treatment:
Biological: Cold-adapted influenza vaccine trivalent (CAIV-T)
Trivalent Inactivated Vaccine (TIV)
Active Comparator group
Description:
A single dose was administered by intramuscular injection.
Treatment:
Biological: Trivalent Inactivated Vaccine (TIV)

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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