Trial to Evaluate the Immune Response to OPV When Administered Concomitantly With CAIV-T to Healthy Children.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00192426
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : October 3, 2006
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
MedImmune LLC

Brief Summary:
Phase III trial to evaluate the immune response to oral poliovirus vaccine (OPV) when administered concomitantly with CAIV-T to healthy children.

Condition or disease Intervention/treatment Phase
Influenza Biological: CAIV-T Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2400 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: A Prospective, Randomized, Partially-Blinded, Placebo-Controlled, Phase III, Multicenter Trial to Assess Safety, Tolerability and Immunogenicity of Liquid CAIV-T Administered Concomitantly With OPV in Healthy Children
Study Start Date : September 2001
Estimated Study Completion Date : December 2001

Primary Outcome Measures :
  1. The primary immunogenicity endpoint is the proportion of subjects achieving a post-vaccination serum antibody response for each antigen component of OPV and CAIV-T.

Secondary Outcome Measures :
  1. The secondary endpoint for immunogenicity is the geometric mean titer (GMT) of serum antibody for each antigen component of OPV or the geometric mean ratio relative to the baseline titer of CAIV-T serum antibody components.

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • who are aged at least 6 months and less than 36 months of age at the time of first vaccination
  • who have received a full primary vaccination schedule consisting of three doses of OPV in the first year of life
  • who are 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 for duration of the trial (3 months)
  • whose parent(s)/legal guardian(s), can be reached by study staff for the post-vaccination contacts [telephone, clinic or home visit].

Exclusion Criteria:

  • 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 (see Section 4.2.1)
  • 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)
  • with a documented history of hypersensitivity to egg or egg protein or any other component of the assigned study vaccine
  • who received aspirin (acetylsalicylic acid) or aspirin-containing products in the two weeks prior to vaccination 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.

If any of these criteria are met following enrollment, 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00192426

Sponsors and Collaborators
MedImmune LLC
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Robert Walker, MD MedImmune LLC Identifier: NCT00192426     History of Changes
Other Study ID Numbers: D153-P511
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: October 3, 2006
Last Verified: October 2006