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

NCT00192335 | Completed Phase 3

• 1 other identifier: MI-CP112
• Study Type: interventional
• Target: 890
• Locations: 1 country
• Sites: 3

Brief Summary

• 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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• - 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

  greater than 28-days post dose

Secondary Outcomes (1)

• The proportion of participants experiencing each of the reactogenicity events by dose.

  Within 28 days of vaccination

Study Arms (2)

1

ACTIVE COMPARATOR

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

2

ACTIVE COMPARATOR

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

Interventions

CAIVT BIOLOGICAL

The total volume of 0.2 mL will be administered intranasally with a spray applicator (approximately 0.1 mL into each nostril).

1

FluMist BIOLOGICAL

The total volume of 0.5 mL will be administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).

2

Eligibility Criteria

• Age: 5 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (3)

Heart of America Research Institute

Shawnee Mission, Kansas, 66216, United States

Location

Kentucky Pediatric/Adult Research, Inc.

Bardstown, Kentucky, 40004, United States

Location

R/D Clinical Research, Inc.

Lake Jackson, Texas, 77566, United States

Location

MeSH Terms

Interventions

FluMist

Study Officials

• Luis Angles, MD

  Heart of America Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 19, 2005
• Study Start: July 1, 2004
• Study Completion: February 1, 2005
• Last Updated: November 27, 2007

Record last verified: 2007-11

Locations

US (3)