Assess the Safety and Immunogenicity of PNEUMOSIL® Vaccine in Healthy Vietnamese Children, 6 Weeks to 24 Months of Age

You may not qualify if:

• Use of any investigational medicinal product prior to randomization or planned use of such a product (other than study vaccine) during the period of study participation. Previous vaccination against Streptococcus pneumoniae.
• History of Streptococcus pneumoniae infection confirmed by culture from a normally sterile site.
• History of allergic disease or history of a serious reaction to any prior vaccination or known hypersensitivity to any component of the study vaccines. This included such reactions in older siblings and also includes all components of the vaccines of expanded program on immunization.
• History of anaphylactic shock.
• Any abnormal (Grade ≥ 1) vital sign. Note: For fever, axillary temperature of ≥ 37.5°C was considered significant and was repeated to determine whether a subject is eligible for randomization. A minimum of 48 hours following resolution of documented fever needed to pass before the subject could be reassessed for eligibility. The last vital sign measurement was used as the baseline value for the study.
• Any moderate or severe (Grade ≥ 2) acute illness Note: Infants with a Grade 1 acute illness were enrolled at the discretion of the Principal Investigator (PI).
• Note: Subjects with moderate or severe acute illness would return for clinical reassessment; if the illness had sufficiently resolved, they might still qualify for randomization.
• Chronic administration (defined as more than 14 consecutive days) of immunosuppressant or other immune modifying drugs prior to the administration of the study vaccine, including the use of glucocorticoids. The use of topical and inhaled glucocorticoids will be permitted.
• History of administration of a non-study pneumococcal vaccine prior to administration of study vaccine or during the course of study participation (other vaccinations of expanded program on Immunization are accepted).
• Administration of immunoglobulins and/or any blood products or anticipation of such administration during the study period.
• Subject had a sibling die of likely sudden infant death syndrome or die suddenly and without apparent other cause or preceding illness in the first year of life.
• Evidence of a clinically significant congenital abnormality as judged by the PI.
• History of meningitis, seizures or any neurological disorder.
• Evidence by history taking alone of exposure to an HIV-positive individual through maternal fetal transmission, breast milk, or other blood-borne mechanisms.
• Subject being a direct descendant (child or grandchild) of any person employed by the Sponsor, the contract research organization (CRO), the PI, study site personnel, or department.
• +1 more criteria