Trial to Demonstrate Equivalent Immunogenicity of CAIV-T and FLUMIST in Healthy Participants

This study has been completed.
Sponsor:
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00192335
First received: September 12, 2005
Last updated: November 26, 2007
Last verified: November 2007
  Purpose
  • Primary objective is to demonstrate equivalent immunogeniticity of CAIV-T and FluMist
  • Secondary objective of this study is to assess the safety and tolerability of CAIV-T compared to FluMist

Condition Intervention Phase
Healthy
Biological: CAIV-T
Biological: CAIVT
Biological: FluMist
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Double-Blind, Randomized Trial to Demonstrate Equivalent Immunogenicity of CAIV-T and FLUMIST in Healthy Participants Ages 5 Through 49 Years

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • - Among participants 5 through 8 years of age regardless of baseline serostatus who receive two doses, the post-dose two strain-specific geometric mean titers (GMTs) for serum HAI in the CAIV-T group are within 2-fold of those in the FluMist group [ Time Frame: greater than 28-days post dose ]

Secondary Outcome Measures:
  • The proportion of participants experiencing each of the reactogenicity events by dose. [ Time Frame: Within 28 days of vaccination ]

Enrollment: 890
Study Start Date: July 2004
Study Completion Date: February 2005
Arms Assigned Interventions
Active Comparator: 1
CAIVT-The total volume of 0.2 mL will be administered intranasally with a spray applicator (approximately 0.1 mL into each nostril).
Biological: CAIV-T Biological: CAIVT
The total volume of 0.2 mL will be administered intranasally with a spray applicator (approximately 0.1 mL into each nostril).
Active Comparator: 2
FluMist- The total volume of 0.5 mL will be administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
Biological: FluMist
The total volume of 0.5 mL will be administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).

  Eligibility

Ages Eligible for Study:   5 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 5 through 49 years (not yet reached their 50th birthday);
  • In general good health;
  • Individual or parent/guardian available by telephone;
  • Ability of the participant or parent/guardian to understand and comply with the requirements of the protocol; and
  • Written informed consent and HIPAA authorization obtained from the participant's parent or legal guardian or written informed consent and HIPAA authorization obtained from the participant.

Exclusion Criteria:

  • History of hypersensitivity to any component of FluMist or CAIV-T, including egg or egg products;
  • History of hypersensitivity to gentamicin;
  • Any known immunosuppressive condition or immune deficiency disease (including HIV infection), or ongoing receipt of any immunosuppressive therapy;
  • Household contact who is immunocompromised (participants should also avoid close contact with other immunocompromised individuals for at least 21 days);
  • History of chronic underlying medical conditions such as chronic disorders of the cardiovascular and pulmonary systems, chronic metabolic diseases (including diabetes), renal dysfunction, or hemoglobinopathies;
  • History of Guillain-Barré syndrome;
  • History of asthma or reactive airways disease;
  • For children age 5 through 8 years, receipt of prior influenza vaccination;
  • Acute febrile (>100.0°F oral) and/or respiratory illness within the 72 hours prior to enrollment;
  • For participants under the age of 18, use of aspirin or aspirin containing products in the 30 days prior to enrollment or anticipated use during the study;
  • Administration of any live vaccine within 30 days prior to enrollment or if receipt of another live vaccine is expected within 30 days of the vaccination in this study;
  • Administration of any inactivated vaccine within two weeks prior to enrollment or if receipt of another inactivated vaccine is expected within two weeks of the vaccination in this study;
  • Pregnancy or, in biologically capable women (e.g., menses within the last year), not willing to agree to acceptable birth control for 90 days after enrolling into the study (for those biologically capable, a urine pregnancy test must be performed on the day of vaccination with a negative result);
  • Breastfeeding or lactating women;
  • Participation in another investigational trial or administration of any investigational drug within 30 days prior to enrollment or during this study;
  • Receipt of any blood product within 90 days prior to vaccination or expected receipt within the study duration;
  • Employees of the research center, any individuals involved with the conduct of the study, or any family member of such individuals; and
  • Any condition that in the opinion of the investigator would interfere with the interpretation or evaluation of the vaccine.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00192335

Locations
United States, Kansas
Heart of America Research Institute
Shawnee Mission, Kansas, United States, 66216
United States, Kentucky
Kentucky Pediatric/Adult Research, Inc.
Bardstown, Kentucky, United States, 40004
United States, Texas
R/D Clinical Research, Inc.
Lake Jackson, Texas, United States, 77566
Sponsors and Collaborators
MedImmune LLC
Investigators
Principal Investigator: Luis Angles, MD Heart of America Research Institute
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00192335     History of Changes
Other Study ID Numbers: MI-CP112
Study First Received: September 12, 2005
Last Updated: November 26, 2007
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 18, 2014