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

This study has been completed.
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00192348
First received: September 12, 2005
Last updated: October 2, 2006
Last verified: October 2006
  Purpose

Trial to compare the safety and tolerability of one and two doses of influenza virus vaccine.


Condition Intervention Phase
Healthy
Biological: CAIV-T
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • - To compare the safety and tolerability of one and two doses of influenza virus vaccine, trivalent,(CAIV-T) with placebo when administered intranasally

Estimated Enrollment: 120
Study Start Date: May 2002
Estimated Study Completion Date: December 2002
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.

  Eligibility

Ages Eligible for Study:   6 Weeks to 24 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00192348

Locations
Finland
University of Tampere
Tampere, Finland, 33014
Sponsors and Collaborators
MedImmune LLC
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Robert Walker, MD MedImmune LLC
  More Information

No publications provided by MedImmune LLC

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00192348     History of Changes
Other Study ID Numbers: D153-P518
Study First Received: September 12, 2005
Last Updated: October 2, 2006
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 19, 2014