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Trial record 1 of 1 for:    NCT00192413
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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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ClinicalTrials.gov Identifier: NCT00192413
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : March 14, 2012
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
MedImmune LLC

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 19, 2005
Last Update Posted Date March 14, 2012
Study Start Date  ICMJE March 2002
Actual Primary Completion Date November 2002   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2012)
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. [ Time Frame: Dosing through 30Nov2002 ]
The criteria for obtaining nasal and throat swabs for viral culture were any one of the following: A feeling of "feverishness", An oral temperature ≥37.2ºC, Sore throat, New or increased cough, Malaise, Myalgia. Swabs for viral cultures were also obtained, if, in the opinion of the investigator, the symptom complex so warranted.
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2012)
  • 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. [ Time Frame: 15 days after dosing through 30Nov2002 ]
    The criteria for obtaining nasal and throat swabs for viral culture were any one of the following: A feeling of "feverishness", An oral temperature ≥37.2ºC, Sore throat, New or increased cough, Malaise, Myalgia. Swabs for viral cultures were also obtained, if, in the opinion of the investigator, the symptom complex so warranted.
  • 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 [ Time Frame: 15 days after dosing through 30Nov2002 ]
    The criteria for obtaining nasal and throat swabs for viral culture were any one of the following: A feeling of "feverishness", An oral temperature ≥37.2ºC, Sore throat, New or increased cough, Malaise, Myalgia. Swabs for viral cultures were also obtained, if, in the opinion of the investigator, the symptom complex so warranted.
  • The first episode in a study subject of a culture-confirmed influenza illness caused by any community-acquired virus of each of the subtypes. [ Time Frame: 15 days after dosing through 30Nov2002 ]
    The criteria for obtaining nasal and throat swabs for viral culture were any one of the following: A feeling of "feverishness", An oral temperature ≥37.2ºC, Sore throat, New or increased cough, Malaise, Myalgia. Swabs for viral cultures were also obtained, if, in the opinion of the investigator, the symptom complex so warranted.
  • The first episode of influenza-like illness [ Time Frame: 15 days after dosing through 30Nov2002 ]
  • Incidence of clinic visits [ Time Frame: 15 days after dosing through 30Nov2002 ]
    A possibility of multiple visits per subject; each visit will be counted once in the analysis.
  • Incidence of hospitalization [ Time Frame: 15 days after dosing through 30Nov2002 ]
  • Incidence of confirmed pneumonia [ Time Frame: 15 days after dosing through 30Nov2002 ]
    Pneumonia means one or more areas of acute interstitial or alveolar infiltrates documented radiographically
  • Incidence of death due to influenza-like illness [ Time Frame: 15 days after dosing through 30Nov2002 ]
    With or without confirmation by viral culture or PCR analysis
  • Incidence of seroconversion [ Time Frame: Day 0-35 ]
    Seroconversion is defined as at least a 4-fold increase in titer from baseline to the sample 35 plus or minus 7 days after vaccination. all subjects were to provide serum samples at 2 time points: at study visit 1 prior to vaccination with CAIV-T or TIV, and 35 days ± 7 days following vaccination (study visit 2).
  • Incidence of systemic reactogenicity events [ Time Frame: Day 0-10 ]
    The 12 systemic reactions were fever with 3 grades defined as ≥37.2°C, ≥38.6°C, and ≥40°C based on the temperature reported on the diary card in addition to the 9 events reported on the diary card.
  • Incidence of local reactions [ Time Frame: Days 0-10 ]
    The local reactions were pain, redness (2 grades: any and significant), and swelling (also 2 grades).
  • Incidence of adverse events [ Time Frame: Days 0-10 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Influenza
Intervention  ICMJE
  • Biological: Cold-adapted influenza vaccine trivalent (CAIV-T)
    Liquid CAIV-T vaccine for this study consisted of 3 cold-adapted, attenuated, reassortant strains, representing the HA and NA antigens of the A/New Caledonia/20/99 (H1N1), A/Panama/2007/99 (H3N2), and B/Victoria/504/2000 influenza strains. The vaccine contained no preservatives and had a pH of 7.2 ± 0.5.
    Other Name: FluMist
  • Biological: Trivalent Inactivated Vaccine (TIV)
    Commercially available TIV, inactivated influenza vaccine (Split Virion) BP (Aventis Pasteur MSD, Lyon, France) was administered IM according to the manufacturer's dosing instructions (one 0.5-mL IM dose for adults).
Study Arms  ICMJE
  • Experimental: Cold-adapted influenza vaccine trivalent (CAIV-T)
    A single 0.2 mL dose of 10^7 fluorescent focus units was administered intranasally.
    Intervention: Biological: Cold-adapted influenza vaccine trivalent (CAIV-T)
  • Active Comparator: Trivalent Inactivated Vaccine (TIV)
    A single dose was administered by intramuscular injection.
    Intervention: Biological: Trivalent Inactivated Vaccine (TIV)
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 12, 2012)
3009
Original Enrollment  ICMJE
 (submitted: September 13, 2005)
3000
Actual Study Completion Date  ICMJE November 2002
Actual Primary Completion Date November 2002   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE South Africa
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00192413
Other Study ID Numbers  ICMJE D153-P516
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Raburn Mallory, MD/ Sr Dir Clinical Development, MedImmune
Study Sponsor  ICMJE MedImmune LLC
Collaborators  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Study Director: Robert Walker, MD MedImmune LLC
PRS Account MedImmune LLC
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP