Trial to Investigate Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine (CAIV-T) in Healthy Children
CAIVT
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
1 other identifier
interventional
173
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2001
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2001
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 19, 2005
CompletedFebruary 17, 2012
February 1, 2012
3 months
September 12, 2005
February 15, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Measurement of influenza-specific immune response following receipt of CAIV-T.
The immune responses were evaluated by hemagglutination inhibition assay (HAI) on serum samples.
Day 0 and Day 27
Secondary Outcomes (4)
Vaccine virus shedding
Days 2, 6, and 13
Measurement of influenza-specific immune response following receipt of CAIVT.
Day 0 and Day 27
Measurement of influenza-specific immune responses following receipt of CAIVT
Day 0, Day 6, and Day 13
Assess the safety and tolerability of CAIV-T vaccine in healthy children.
Day 0-27
Study Arms (4)
CAIV-T 10^5
EXPERIMENTALa single intranasal 0.2 mL dose of liquid CAIV-T 10\^5 (approximately 0.1 mL into each nostril)
CAIVT 10^7
EXPERIMENTALA single intranasal 0.2 mL dose of liquid CAIV-T 10\^7 (approximately 0.1 mL into each nostril)
Placebo
PLACEBO COMPARATORA single intranasal 0.2 mL dose of placebo
Trivalent inactivated vaccine (TIV)
ACTIVE COMPARATORA single intramuscular injection of commercially available vaccine
Interventions
a single intranasal 0.2 mL dose of liquid CAIV-T 107 (approximately 0.1 mL into each nostril)
Eligibility Criteria
You may qualify if:
- 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);
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MedImmune LLClead
- Wyeth is now a wholly owned subsidiary of Pfizercollaborator
Study Sites (2)
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652, United States
Division of Allergy Immunology and Infectious Disease
Pittsburgh, Pennsylvania, 15213, United States
Related Publications (1)
Mendelman PM, Rappaport R, Cho I, Block S, Gruber W, August M, Dawson D, Cordova J, Kemble G, Mahmood K, Palladino G, Lee MS, Razmpour A, Stoddard J, Forrest BD. Live attenuated influenza vaccine induces cross-reactive antibody responses in children against an a/Fujian/411/2002-like H3N2 antigenic variant strain. Pediatr Infect Dis J. 2004 Nov;23(11):1053-5. doi: 10.1097/01.inf.0000143643.44463.b1.
PMID: 15545863RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Walker, MD
MedImmune LLC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 19, 2005
Study Start
September 1, 2001
Primary Completion
December 1, 2001
Study Completion
December 1, 2001
Last Updated
February 17, 2012
Record last verified: 2012-02