Trial to Determine the Safety and Efficacy of Influenza Virus Vaccine, Trivalent, Types A & B, Live, Cold-Adapted (CAIV-T) in Healthy Children

NCT00192244

Last updated date
Study Location
The Prince of Wales Hospital
Hong Kong, , , China
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

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

- who are greater than or equal to 6 months 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 judgment;

- whose parent or legal guardian has provided written informed consent after the nature of the study has been explained;

- who, along with their parent or legal guardian, will be available for the duration of the study (24 months);

- whose parent/legal guardian can be reached by study staff for the post-immunization contacts [via telephone, clinic or home visits].

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


- whose parents or caregiver are perceived to be unreliable 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;


- with an immunosuppressed or compromised 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 were administered any live virus vaccine within one month prior to study
vaccination or expected receipt of another live virus within one month of vaccination
in this study;


- with a documented history of hypersensitivity to egg or egg protein, or any other
component of the study vaccines or placebo;


- with a 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;


- with any medical conditions that in the opinion of the Investigator might interfere
with interpretation of the study results; Note: A pregnant household member or day
care provider is not considered a contraindication to enrollment.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

HealthySingle Ascending Dose Study of Intravenous Infusion of PF 07304814 in Healthy Adult Participants
NCT04627532
  1. New Haven, Connecticut
ALL GENDERS
18 Years+
years
MULTIPLE SITES
HealthyPharmacokinetics of Voriconazole in Obese Subjects
NCT01030653
  1. Paramus, New Jersey
ALL GENDERS
18 Years+
years
MULTIPLE SITES
HealthyA Study to Determine the Bioequivalence of Two Doses of Tafamidis
NCT04575116
  1. New Haven, Connecticut
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Trial to Determine the Safety and Efficacy of Influenza Virus Vaccine, Trivalent, Types A & B, Live, Cold-Adapted (CAIV-T) in Healthy Children
Official Title  ICMJE A Prospective, Randomized, Double-Blind, Placebo-Controlled, Trial to Determine the Safety and Efficacy of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (CAIV-T) in Healthy Children
Brief Summary - The purpose of this study is to determine the efficacy of CAIV-T in a diverse Asian population aged from 6 months to less than 36 months, in tropical and temperate climates, against culture-confirmed influenza illness. In addition, the trial provides the opportunity to investigate the efficacy of CAIV-T over multiple influenza seasons, and to investigate the effect of CAIV-T on acute otitis media.
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: Prevention
Condition  ICMJE Healthy
Intervention  ICMJE Biological: CAIV-T, Liquid
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   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 12, 2005)
3000
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE October 2002
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • who are greater than or equal to 6 months 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 judgment;
  • whose parent or legal guardian has provided written informed consent after the nature of the study has been explained;
  • who, along with their parent or legal guardian, will be available for the duration of the study (24 months);
  • whose parent/legal guardian can be reached by study staff for the post-immunization contacts [via telephone, clinic or home visits].

Exclusion Criteria:

  • whose parents or caregiver are perceived to be unreliable 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;
  • with an immunosuppressed or compromised 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 were administered any live virus vaccine within one month prior to study vaccination or expected receipt of another live virus within one month of vaccination in this study;
  • with a documented history of hypersensitivity to egg or egg protein, or any other component of the study vaccines or placebo;
  • with a 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;
  • with any medical conditions that in the opinion of the Investigator might interfere with interpretation of the study results; Note: A pregnant household member or day care provider is not considered a contraindication to enrollment.
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 China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00192244
Other Study ID Numbers  ICMJE D153-P501
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