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

MedImmune LLC0 sites2,400 target enrollmentSeptember 2001

ConditionsInfluenza

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Influenza
Sponsor: MedImmune LLC
Enrollment: 2400
Primary Endpoint: 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.
Status: Completed
Last Updated: 19 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

September 2001

End Date

December 2001

Last Updated

19 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

MedImmune LLC

Eligibility Criteria

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

Outcomes

Primary Outcomes

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 Outcomes

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.