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

NCT00192322

Last updated date
Study Location
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652, United States
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
6-36 months
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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


- 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.

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InfluenzaTrial to Investigate Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine (CAIV-T) in Healthy Children
NCT00192322
  1. New Port Richey, Florida
  2. Pittsburgh, Pennsylvania
ALL GENDERS
6 Months+
years
MULTIPLE SITES
InfluenzaTrial to Investigate Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine,(CAIV-T)
NCT00192231
  1. Heidelburg, Victoria
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Trial to Investigate Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine (CAIV-T) in Healthy Children
Official Title  ICMJE 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
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.

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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Influenza
Intervention  ICMJE
  • Biological: CAIV-T 10^7
    a single intranasal 0.2 mL dose of liquid CAIV-T 107 (approximately 0.1 mL into each nostril)
  • Biological: CAIVT 10^5
    a single intranasal 0.2 mL dose of CAIV-T <10^5
  • Biological: Placebo
    a single intranasal 0.2 mL dose of placebo
  • Biological: TIV
    commercially available TIV injected intramuscularly
Study Arms  ICMJE
  • 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)
    Intervention: Biological: CAIVT 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)
    Intervention: Biological: CAIV-T 10^7
  • Placebo Comparator: Placebo
    A single intranasal 0.2 mL dose of placebo
    Intervention: Biological: Placebo
  • Active Comparator: Trivalent inactivated vaccine (TIV)
    A single intramuscular injection of commercially available vaccine
    Intervention: Biological: TIV
Publications * 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.

*   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: February 15, 2012)
173
Original Enrollment  ICMJE
 (submitted: September 12, 2005)
240
Actual Study Completion Date  ICMJE December 2001
Actual Primary Completion Date December 2001   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 6 Months to 36 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00192322
Other Study ID Numbers  ICMJE D153-P002
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
Principal Investigator:Robert Walker, MDMedImmune LLC
PRS Account MedImmune LLC
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP