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

NCT00192400 | Completed Phase 3

• 1 other identifier: D153-P504
• Study Type: interventional
• Target: 2,160
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• The primary endpoint for efficacy is the first episode in the first season in a study child of a culture-confirmed influenza illness, caused by community-acquired subtypes antigenically similar to those contained in the vaccine.

Secondary Outcomes (1)

• The first episode in the second season in a study child of a culture-confirmed influenza illness, caused by community-acquired subtypes antigenically similar to those contained in the vaccine.

Interventions

CAIV-T BIOLOGICAL

Eligibility Criteria

• Age: 6 Months - 35 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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 \[telephone, clinic or home visit\].

You may not qualify if:

• 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.

Sponsors & Collaborators

• MedImmune LLC: lead
• Wyeth is now a wholly owned subsidiary of Pfizer: collaborator

Related Publications (1)

• 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.

  PMID: 19395948 DERIVED

MeSH Terms

Interventions

FluMist

Study Officials

• Robert Walker, MD

  MedImmune LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: ECT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 19, 2005
• Study Start: March 1, 2002
• Study Completion: November 1, 2002
• Last Updated: October 3, 2006

Record last verified: 2006-10