| Eligibility |
Inclusion Criteria:
1. Healthy infants or toddlers, based on medical history and clinical assessment, to be
without acute or chronic, clinically significant pulmonary, cardiovascular,
hepatobiliary, gastrointestinal, renal, neurological, or hematological functional
abnormality or illness that requires medical therapy.
2. Infants or toddlers between 6 weeks to 24 months of age at the first dose
3. Voluntary written informed consent by subject's parents to have the subject
participate in the study.
4. Subject's parents being able to comprehend and comply with study requirements and
procedures and able and willing to complete subject diary, to return with the subject
for all scheduled follow-up visits
5. Subjects born full-term with a weight-to-length Z score of = -2 (WHO child growth
standard) at enrollment.
6. Subject with an up-to-date minimal vaccination status for age at the time of
enrollment as per National Immunization Program.
7. Subject's parents having a readily identifiable place of residence in the study area,
being available for the duration of trial participation, with means of telephone
contact.
Exclusion Criteria:
1. 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.
2. History of Streptococcus pneumoniae infection confirmed by culture from a normally
sterile site.
3. 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.
4. History of anaphylactic shock.
5. 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.
6. 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.
7. 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.
8. 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).
9. Administration of immunoglobulins and/or any blood products or anticipation of such
administration during the study period.
10. History of known disturbance of coagulation or blood disorder that could cause anemia
or excess bleeding (e.g., coagulation factor deficiencies, severe anemia at birth).
Any clearly documented history in a first-degree relative (e.g., parent, sibling) of
the same was also exclusionary.
11. History of suspected primary immunodeficiency. Any clearly documented history in a
first-degree relative of the same was also exclusionary.
12. 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.
13. Evidence of a clinically significant congenital abnormality as judged by the PI.
14. History of meningitis, seizures or any neurological disorder.
15. Evidence by history taking alone of exposure to an HIV-positive individual through
maternal fetal transmission, breast milk, or other blood-borne mechanisms.
16. 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.
17. Any medical or social condition that in the opinion of the PI might interfere with the
study objectives, pose a risk to the subject, or prevent the subject from completing
the study follow-up.
Note: The specific exclusion criteria (e.g., abnormal vital sign, acute illness) were
reassessed at all vaccination visits. Any subject who was not vaccinated due to an acute
abnormality assessed at the 2nd or 3rd vaccination visit (V2 or V3) would return once the
acute issue has resolved. A minimum of 48 hours must have passed after a documented fever
before a subject could be vaccinated. This safety requirement was not deemed a protocol
deviation if the visit fell outside the vaccination window; however, it was encouraged to
maintain the vaccination window whenever possible in these situations.
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