A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety and Tolerability of Influenza Virus Vaccine,(CAIV-T) in Healthy Infants

NCT00192348

Last updated date
Study Location
University of Tampere
Tampere, , 33014, Finland
Contact
1-800-718-1021

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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
6-24 weeks
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- children at least 6 weeks of age and less than 24 weeks of age at the time of enrollment, of >37 weeks gestational age and with a birth weight of >2500 g, and in good health as determined by medical history, physical examination and clinical judgment;

- whose parent/legal guardian provided written informed consent after the nature of the study was explained;

- who, along with their parent or legal guardian, were available for the three month duration of the trial (from enrollment to study completion);

- whose parent(s)/legal guardian(s), could 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


- whose parents or legal guardians were 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;


- who received any blood products, including immunoglobulin, in the period from birth
through to the conclusion of the study;


- had 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 vaccines or placebo;


- who were administered any live virus vaccine within one month prior to enrollment; or
expected to receive another live vaccine within 1 month of vaccination in the study.


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


- who received a dose of influenza treatment (commercial or investigational) two weeks
prior to enrollment. The prophylactic use of influenza antivirals was not permitted;


- who, at anytime prior to study enrollment, received any influenza vaccine (commercial
or investigational);


- with a respiratory illness with wheezing within two weeks prior to each dose of study
vaccine;


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


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


Note: Pregnancy in any person who had regular contact with the subjects was not considered
a contraindication to enrollment.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety and Tolerability of Influenza Virus Vaccine,(CAIV-T) in Healthy Infants
Official Title  ICMJE A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety and Tolerability of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold Adapted (CAIV-T) in Healthy Infants
Brief Summary Trial to compare the safety and tolerability of one and two doses of influenza virus vaccine.
Detailed Description The objective of this study was to compare the safety and tolerability of one and two doses of influenza virus vaccine, trivalent, types A and B, live cold-adapted liquid (CAIV-T) with placebo when administered intranasally to healthy infants aged 6 < 24 weeks.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE Biological: CAIV-T
Study Arms  ICMJE Not Provided
Publications * Vesikari T, Karvonen A, Smith HM, Dunning A, Razmpour A, Saville MK, Gruber WC, Forrest BD. Safety and tolerability of cold-adapted influenza vaccine, trivalent, in infants younger than 6 months of age. Pediatrics. 2008 Mar;121(3):e568-73. doi: 10.1542/peds.2007-1405. Epub 2008 Feb 25.

*   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)
120
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE December 2002
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • children at least 6 weeks of age and less than 24 weeks of age at the time of enrollment, of >37 weeks gestational age and with a birth weight of >2500 g, and in good health as determined by medical history, physical examination and clinical judgment;
  • whose parent/legal guardian provided written informed consent after the nature of the study was explained;
  • who, along with their parent or legal guardian, were available for the three month duration of the trial (from enrollment to study completion);
  • whose parent(s)/legal guardian(s), could be reached by study staff for the post-vaccination contacts [telephone, clinic or home visit].

Exclusion Criteria:

  • whose parents or legal guardians were 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;
  • who received any blood products, including immunoglobulin, in the period from birth through to the conclusion of the study;
  • had 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 vaccines or placebo;
  • who were administered any live virus vaccine within one month prior to enrollment; or expected to receive another live vaccine within 1 month of vaccination in the study.
  • for whom there was intent to administer any other investigational vaccine or agent from one month prior to enrollment through to the conclusion of the study;
  • who received a dose of influenza treatment (commercial or investigational) two weeks prior to enrollment. The prophylactic use of influenza antivirals was not permitted;
  • who, at anytime prior to study enrollment, received any influenza vaccine (commercial or investigational);
  • with a respiratory illness with wheezing within two weeks prior to each dose of study vaccine;
  • who received aspirin (acetylsalicylic acid) or aspirin-containing products in the two weeks prior to enrollment or for which use was anticipated during the study;
  • with any medical conditions that in the opinion of the investigator might have interfered with interpretation of the study results.

Note: Pregnancy in any person who had regular contact with the subjects was not considered a contraindication to enrollment.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 6 Weeks to 24 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00192348
Other Study ID Numbers  ICMJE D153-P518
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