ABOUT THIS STUDY
- children at least 6 weeks of age and less than 24 weeks of age at the time of enrollment, of >37 weeks gestational age and with a birth weight of >2500 g, and in good health as determined by medical history, physical examination and clinical judgment;
- whose parent/legal guardian provided written informed consent after the nature of the study was explained;
- who, along with their parent or legal guardian, were available for the three month duration of the trial (from enrollment to study completion);
- whose parent(s)/legal guardian(s), could be reached by study staff for the post-vaccination contacts [telephone, clinic or home visit].
- whose parents or legal guardians were 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; or cytotoxic agents;
- who received any blood products, including immunoglobulin, in the period from birth
through to the conclusion of the study;
- had an immunosuppressed or an immunocompromised individual living in the same
- with a documented history of hypersensitivity to egg or egg protein or any other
component of the study vaccines or placebo;
- who were administered any live virus vaccine within one month prior to enrollment; or
expected to receive another live vaccine within 1 month of vaccination in the study.
- for whom there was intent to administer any other investigational vaccine or agent
from one month prior to enrollment through to the conclusion of the study;
- who received a dose of influenza treatment (commercial or investigational) two weeks
prior to enrollment. The prophylactic use of influenza antivirals was not permitted;
- who, at anytime prior to study enrollment, received any influenza vaccine (commercial
- with a respiratory illness with wheezing within two weeks prior to each dose of study
- who received aspirin (acetylsalicylic acid) or aspirin-containing products in the two
weeks prior to enrollment or for which use was anticipated during the study;
- with any medical conditions that in the opinion of the investigator might have
interfered with interpretation of the study results.
Note: Pregnancy in any person who had regular contact with the subjects was not considered
a contraindication to enrollment.
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