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Trial to Investigate Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine (CAIV-T) in Healthy Children (CAIVT)

This study has been completed.
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00192322
First received: September 12, 2005
Last updated: February 15, 2012
Last verified: February 2012
  Purpose

To perform a variety of assays on blood, nasal washes, and cells obtained from healthy children for the purposes of further investigation of immune responses generated by influenza virus vaccine, trivalent, types A and B, live, cold-adapted (liquid CAIV-T; Wyeth Lederle Vaccines, Marietta, PA).

• To assess nasal swab specimens to detect vaccine virus shedding.


Condition Intervention Phase
Influenza
Biological: CAIV-T 10^7
Biological: CAIVT 10^5
Biological: Placebo
Biological: TIV
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Partially-Blinded, Placebo-Controlled Trial to Investigate Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine, Trivalent,Types A & B, Live Cold Adapted (CAIV-T) in Healthy Children Aged 6 to Less Than 36 Months

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • Measurement of influenza-specific immune response following receipt of CAIV-T. [ Time Frame: Day 0 and Day 27 ] [ Designated as safety issue: No ]
    The immune responses were evaluated by hemagglutination inhibition assay (HAI) on serum samples.


Secondary Outcome Measures:
  • Vaccine virus shedding [ Time Frame: Days 2, 6, and 13 ] [ Designated as safety issue: No ]
    The number of subjects who shed influenza virus vaccine subtypes following vaccination.

  • Measurement of influenza-specific immune response following receipt of CAIVT. [ Time Frame: Day 0 and Day 27 ] [ Designated as safety issue: No ]
    The immune responses were evaluated by mucosal IgA ELISA on nasal wash samples.

  • Measurement of influenza-specific immune responses following receipt of CAIVT [ Time Frame: Day 0, Day 6, and Day 13 ] [ Designated as safety issue: No ]
    The immune responses were evaluated by assays of cellular immunity (IFN-gamma ELISPOT) and assays that measured the number of antibody secreting cells (B-cell ELISPOT).

  • Assess the safety and tolerability of CAIV-T vaccine in healthy children. [ Time Frame: Day 0-27 ] [ Designated as safety issue: Yes ]
    Adverse events and serious adverse events were collect from Day 0 till the end of the study Day 27.


Enrollment: 173
Study Start Date: September 2001
Study Completion Date: December 2001
Primary Completion Date: December 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CAIV-T 10^5
a single intranasal 0.2 mL dose of liquid CAIV-T 10^5 (approximately 0.1 mL into each nostril)
Biological: CAIVT 10^5
a single intranasal 0.2 mL dose of CAIV-T <10^5
Experimental: CAIVT 10^7
A single intranasal 0.2 mL dose of liquid CAIV-T 10^7 (approximately 0.1 mL into each nostril)
Biological: CAIV-T 10^7
a single intranasal 0.2 mL dose of liquid CAIV-T 107 (approximately 0.1 mL into each nostril)
Placebo Comparator: Placebo
A single intranasal 0.2 mL dose of placebo
Biological: Placebo
a single intranasal 0.2 mL dose of placebo
Active Comparator: Trivalent inactivated vaccine (TIV)
A single intramuscular injection of commercially available vaccine
Biological: TIV
commercially available TIV injected intramuscularly

Detailed Description:

This was a phase II, prospective, randomized, partially-blinded, placebo-controlled, outpatient study conducted at multiple sites throughout the US in healthy children aged 6 months to less than 36 months. Parents/guardians of subjects were asked to read and sign the informed consent before any study-related procedures were performed. Subjects at each study site were sequentially assigned to 1 of 2 separate blood sample groups referred to as "cellular immunity" or "antibody secreting cell". Subjects within each blood sample group were then randomized 1:1:1:1 to receive a single intranasal dose of CAIV-T 10^7 FFU per dose, CAIV-T 10^5 FFU per dose, placebo or a commercially-available injectable trivalent influenza vaccine (TIV).

  Eligibility

Ages Eligible for Study:   6 Months to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • children at least 6 months of age and less than 36 months of age at the time of enrollment, and in good health as determined by medical history, physical examination and clinical judgement;
  • whose parent/legal guardian has provided written informed consent after the nature of the study has been explained;
  • who, along with their parent or guardian, will be available for the one month duration of the trial (from enrollment to study completion);

Exclusion Criteria:

  • whose parents or guardians are perceived to be unavailable or difficult to contact for evaluation or study visits during the study period;
  • with any serious chronic disease (e.g., with signs of cardiac or renal failure or severe malnutrition), including progressive neurological disease;
  • with Down's syndrome or other known cytogenetic disorders;
  • with a known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids, or cytotoxic agents (see Section 4.2.2);
  • 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 study vaccine, placebo or TIV;
  • who, at anytime prior to study enrollment, receives any influenza vaccine (commercial or investigational);
  • 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.

  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: NCT00192322

Locations
United States, Florida
Suncoast Clinical Research, Inc.
New Port Richey, Florida, United States, 34652
United States, Pennsylvania
Division of Allergy Immunology and Infectious Disease
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
MedImmune LLC
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Principal Investigator: Robert Walker, MD MedImmune LLC
  More Information

Publications:
Responsible Party: Raburn Mallory, MD/ Sr Dir Clinical Development, MedImmune
ClinicalTrials.gov Identifier: NCT00192322     History of Changes
Other Study ID Numbers: D153-P002
Study First Received: September 12, 2005
Last Updated: February 15, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 24, 2014