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

NCT00192413

Last updated date
Study Location
Docnor House
Durban North, Dwazulu Natal, , South Africa
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Influenza
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
60 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
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, MDMedImmune 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