Status:
COMPLETED
Trial to Evaluate the Immune Response to OPV When Administered Concomitantly With CAIV-T to Healthy Children.
Lead Sponsor:
MedImmune LLC
Collaborating Sponsors:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Influenza
Eligibility:
All Genders
6-36 years
Phase:
PHASE3
Brief Summary
Phase III trial to evaluate the immune response to oral poliovirus vaccine (OPV) when administered concomitantly with CAIV-T to healthy children.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2001
Trial Type :
INTERVENTIONAL
End Date :
December 1 2001
Estimated Enrollment :
2400 Patients enrolled
Trial Details
Trial ID
NCT00192426
Start Date
September 1 2001
End Date
December 1 2001
Last Update
October 3 2006
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