Clinical trial NCT00192413: 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
Official title: A Prospective, Randomized, Open-Label, Controlled Trial to Compare the Safety, Tolerability, and Efficacy of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (CAIV-T) With Inactivated, Influenza Vaccine, Trivalent, Types A & B, in Adults Aged 60 Years and Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
Collaborators: name: Wyeth is now a wholly owned subsidiary of Pfizer
First posted: 2005-09-19
Enrollment: 3009
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: The first episode of a culture-confirmed influenza-illness, caused by community-acquired subtypes antigenically similar to those contained in the vaccine, which occurs at least 15 days following receipt of a dose of study vaccine.
timeFrame: Dosing through 30Nov2002
Secondary outcomes:
measure: The first episode of a culture-confirmed influenza-illness, caused by any community-acquired subtype, which occurs at least 15 days following receipt of a dose of study vaccine.
timeFrame: 15 days after dosing through 30Nov2002
measure: The first episode in a study subject of a culture-confirmed influenza illness caused by community-acquired virus of each of the subtypes antigenically similar to those contained in the vaccine
timeFrame: 15 days after dosing through 30Nov2002
measure: The first episode in a study subject of a culture-confirmed influenza illness caused by any community-acquired virus of each of the subtypes.
timeFrame: 15 days after dosing through 30Nov2002
measure: The first episode of influenza-like illness
timeFrame: 15 days after dosing through 30Nov2002
measure: Incidence of clinic visits
timeFrame: 15 days after dosing through 30Nov2002
measure: Incidence of hospitalization
timeFrame: 15 days after dosing through 30Nov2002
measure: Incidence of confirmed pneumonia
timeFrame: 15 days after dosing through 30Nov2002
measure: Incidence of death due to influenza-like illness
timeFrame: 15 days after dosing through 30Nov2002
measure: Incidence of seroconversion
timeFrame: Day 0-35
measure: Incidence of systemic reactogenicity events
timeFrame: Day 0-10
measure: Incidence of local reactions
timeFrame: Days 0-10
measure: Incidence of adverse events
timeFrame: Days 0-10
Other outcomes:
Locations:
city: Durban North
country: South Africa
facility: Docnor House
state: Dwazulu Natal
city: Hazelwood
country: South Africa
facility: Hazelmed Family Practice
state: Pretoria
city: Amanzimtoti
country: South Africa
facility: Jansen van Rensburg
city: Scottburgh South
country: South Africa
facility: Christiaan Tertius de Villiers
Study officials:
affiliation: MedImmune LLC
name: Robert Walker, MD
role: STUDY_DIRECTOR
References:
citation: Forrest BD, Steele AD, Hiemstra L, Rappaport R, Ambrose CS, Gruber WC. A prospective, randomized, open-label trial comparing the safety and efficacy of trivalent live attenuated and inactivated influenza vaccines in adults 60 years of age and older. Vaccine. 2011 May 9;29(20):3633-9. doi: 10.1016/j.vaccine.2011.03.029. Epub 2011 Apr 5.