Trial to Assess the Safety and Tolerability of the Liquid Formulation of CAIV-T in Healthy Children.

NCT00192400

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6-35 months
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

(First Season)

- who is aged at least 6 months and less than 36 months of age at the time of enrollment;

- who is in good health as determined by medical history, physical examination and clinical judgement;

- whose parent(s)/legal guardian(s) have provided written informed consent after the nature of the study has been explained;

- who, along with their parent(s)/legal guardian(s), will be available until the completion of the first season's surveillance phase;

- whose parent(s)/legal guardian(s), can be reached by study staff for the post-vaccination contacts [telephone, clinic or home visit].

(Second Season)

- who was enrolled into the first season of the trial and received at least one vaccination in the primary series;

- who completed the safety and efficacy evaluations during the first season surveillance phase;

- who is in good health as determined by medical history, physical examination and clinical judgement;

- whose parent(s)/legal guardian(s) have provided written informed consent for the second season of the trial after the nature of the study has been explained;

- who, along with their parent(s)/legal guardian(s), will be available until the completion of the second season's surveillance phase;

- whose parent(s)/legal guardian(s), can be reached by study staff for the post-vaccination contacts [telephone, clinic or home visit].

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

(First Season)


- whose parent(s)/legal guardian(s) 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;


- who received any blood products, including immunoglobulin, in the period from six
months prior to vaccination through to the conclusion of the study;


- for whom there is intent to administer any other investigational vaccine or agent from
one month prior to enrollment through to the conclusion of the study;


- have an immunosuppressed or an immunocompromised individual living in the same
household;


- who, at any time prior to entry into this study, received a dose of any influenza
vaccine (commercial or investigational);


- who, in the two weeks prior to entry into this study, received a dose of any influenza
treatment (commercial or investigational);


- with a documented history of hypersensitivity to egg or egg protein or any other
component of the assigned study vaccine;


- with a clinically confirmed respiratory illness with wheezing within two weeks prior
to enrollment;


- who received aspirin (acetylsalicylic acid) or aspirin-containing products in the two
weeks prior to enrollment or for which use is anticipated during the study;


- who were administered any live virus vaccine within one month prior to enrollment or
expected to receive another live virus vaccine within one month of vaccination in this
study;


- with any medical conditions that in the opinion of the investigator might interfere
with interpretation of the study results.


If any of these criteria are met following enrolment, the subject will be excluded from
subsequent vaccine dosing.


Note: Pregnancy in a household member or any person who has regular contact with the
subject is not a contraindication to the enrollment or ongoing participation of the subject
in the study.


(Second Season)


- whose parent(s)/legal guardian(s) 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 corticosteroid of a dose equivalent to 2
mg/kg/day or greater of prednisolone or equivalent to a total of 20 mg/day or greater
for children who weigh more than 10 kg, for more than 14 days duration until 2 weeks
after corticosteroids have been discontinued;


- who received any blood products, including immunoglobulin, in the period from six
months prior to the second season vaccination through to the conclusion of the study;


- for whom there is intent to administer any other investigational vaccine or agent from
one month prior to the second season vaccination through to the conclusion of the
study;


- have an immunosuppressed or an immunocompromised individual living in the same
household;


- who, at any time prior to entry into this study, received a dose of any influenza
vaccine (commercial or investigational) with the exception of the primary series of
study vaccine (CAIV-T/placebo);


- who, in the two weeks prior to receiving the second season vaccination, received a
dose of any influenza treatment (commercial or investigational);


- with a documented history of hypersensitivity to egg or egg protein or any other
component of the assigned study vaccine (CAIV-T/placebo);


- with a clinically confirmed respiratory illness with wheezing within two weeks prior
to receiving the second season vaccination;


- who received aspirin (acetylsalicylic acid) or aspirin-containing products in the two
weeks prior to receiving the second season vaccination or for which use is anticipated
during the study;


- who were administered any live virus vaccine within one month prior to receiving the
second season vaccination or expected to receive another live virus vaccine within one
month of receiving the second season vaccination;


- with any medical conditions that in the opinion of the investigator might interfere
with interpretation of the study results.


Note: Pregnancy in a household member or any person who has regular contact with the
subject is not a contraindication to the enrollment or ongoing participation of the subject
in the study.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Trial to Assess the Safety and Tolerability of the Liquid Formulation of CAIV-T in Healthy Children.
Official Title  ICMJE A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial to Compare the Safety, Tolerability, Immunogenicity and Efficacy of One Dose and Two Doses of a Liquid Formulation of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (CAIV-T) Compared With Placebo in Healthy Children
Brief Summary The purpose of this study is to determine the efficacy of the liquid formulation of CAIV-T against culture confirmed influenza illness in healthy children aged at least 6 months and less than 36 months.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Educational/Counseling/Training
Condition  ICMJE Healthy
Intervention  ICMJE Biological: CAIV-T
Study Arms  ICMJE Not Provided
Publications * Bracco Neto H, Farhat CK, Tregnaghi MW, Madhi SA, Razmpour A, Palladino G, Small MG, Gruber WC, Forrest BD; D153-P504 LAIV Study Group. Efficacy and safety of 1 and 2 doses of live attenuated influenza vaccine in vaccine-naive children. Pediatr Infect Dis J. 2009 May;28(5):365-71. doi: 10.1097/INF.0b013e31819219b8.

*   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
Enrollment  ICMJE
 (submitted: September 13, 2005)
2160
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE November 2002
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria: (First Season)

  • who is aged at least 6 months and less than 36 months of age at the time of enrollment;
  • who is in good health as determined by medical history, physical examination and clinical judgement;
  • whose parent(s)/legal guardian(s) have provided written informed consent after the nature of the study has been explained;
  • who, along with their parent(s)/legal guardian(s), will be available until the completion of the first season's surveillance phase;
  • whose parent(s)/legal guardian(s), can be reached by study staff for the post-vaccination contacts [telephone, clinic or home visit].

(Second Season)

  • who was enrolled into the first season of the trial and received at least one vaccination in the primary series;
  • who completed the safety and efficacy evaluations during the first season surveillance phase;
  • who is in good health as determined by medical history, physical examination and clinical judgement;
  • whose parent(s)/legal guardian(s) have provided written informed consent for the second season of the trial after the nature of the study has been explained;
  • who, along with their parent(s)/legal guardian(s), will be available until the completion of the second season's surveillance phase;
  • whose parent(s)/legal guardian(s), can be reached by study staff for the post-vaccination contacts [telephone, clinic or home visit].

Exclusion Criteria: (First Season)

  • whose parent(s)/legal guardian(s) 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;
  • who received any blood products, including immunoglobulin, in the period from six months prior to vaccination through to the conclusion of the study;
  • for whom there is intent to administer any other investigational vaccine or agent from one month prior to enrollment through to the conclusion of the study;
  • have an immunosuppressed or an immunocompromised individual living in the same household;
  • who, at any time prior to entry into this study, received a dose of any influenza vaccine (commercial or investigational);
  • who, in the two weeks prior to entry into this study, received a dose of any influenza treatment (commercial or investigational);
  • with a documented history of hypersensitivity to egg or egg protein or any other component of the assigned study vaccine;
  • with a clinically confirmed respiratory illness with wheezing within two weeks prior to enrollment;
  • who received aspirin (acetylsalicylic acid) or aspirin-containing products in the two weeks prior to enrollment or for which use is anticipated during the study;
  • who were administered any live virus vaccine within one month prior to enrollment or expected to receive another live virus vaccine within one month of vaccination in this study;
  • with any medical conditions that in the opinion of the investigator might interfere with interpretation of the study results.

If any of these criteria are met following enrolment, the subject will be excluded from subsequent vaccine dosing.

Note: Pregnancy in a household member or any person who has regular contact with the subject is not a contraindication to the enrollment or ongoing participation of the subject in the study.

(Second Season)

  • whose parent(s)/legal guardian(s) 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 corticosteroid of a dose equivalent to 2 mg/kg/day or greater of prednisolone or equivalent to a total of 20 mg/day or greater for children who weigh more than 10 kg, for more than 14 days duration until 2 weeks after corticosteroids have been discontinued;
  • who received any blood products, including immunoglobulin, in the period from six months prior to the second season vaccination through to the conclusion of the study;
  • for whom there is intent to administer any other investigational vaccine or agent from one month prior to the second season vaccination through to the conclusion of the study;
  • have an immunosuppressed or an immunocompromised individual living in the same household;
  • who, at any time prior to entry into this study, received a dose of any influenza vaccine (commercial or investigational) with the exception of the primary series of study vaccine (CAIV-T/placebo);
  • who, in the two weeks prior to receiving the second season vaccination, received a dose of any influenza treatment (commercial or investigational);
  • with a documented history of hypersensitivity to egg or egg protein or any other component of the assigned study vaccine (CAIV-T/placebo);
  • with a clinically confirmed respiratory illness with wheezing within two weeks prior to receiving the second season vaccination;
  • who received aspirin (acetylsalicylic acid) or aspirin-containing products in the two weeks prior to receiving the second season vaccination or for which use is anticipated during the study;
  • who were administered any live virus vaccine within one month prior to receiving the second season vaccination or expected to receive another live virus vaccine within one month of receiving the second season vaccination;
  • with any medical conditions that in the opinion of the investigator might interfere with interpretation of the study results.

Note: Pregnancy in a household member or any person who has regular contact with the subject is not a contraindication to the enrollment or ongoing participation of the subject in the study.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 6 Months to 35 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00192400
Other Study ID Numbers  ICMJE D153-P504
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE MedImmune LLC
Collaborators  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Study Director:Robert Walker, MDMedImmune LLC
PRS Account MedImmune LLC
Verification Date October 2006

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