ABOUT THIS STUDY
- 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].
- 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
- 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.
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