Health Condition 1: Z23- Encounter for immunization
Conditions
Interventions
Intervention1: Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) (24 Valent): Each 0.5 mL will be administered intramuscularly in the anterolateral aspect of mid or upper thigh (vastus laterali
Sponsors
Biological E.Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy pneumococcal conjugate vaccine-naïve (PCV-naive) infants as established by medical history and the clinical assessment before entering into the study. PCV-naïve infants are those who have not been previously vaccinated with any licensed or investigational pneumococcal vaccine. 2. Infants between 6-8 weeks of age (42-56 days, both days inclusive) of either gender, at the time of first dose of vaccination. 3. Healthy Infants with body weight = 3300 gms at the time of screening. 4. Subjects’ parent(s)/ LAR(s) who, in the opinion of the investigator, can and will comply, with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits, with access to a consistent means of telephone contact, either residential landline or mobile). 5. Subject’s parent(s)/LAR(s) willing to provide written or thumb printed informed consent (including audio visual recording of consent process) prior to performing any study specific procedure 6. Infants with a minimal vaccination status for their age at the time of enrolment (“minimal ? defined as single birth dose of BCG, Hepatitis B and Polio vaccine at the time of enrolment).
Exclusion criteria
Exclusion criteria: 1.Child in care 2. Evidence of previous Streptococcus pneumoniae infection or pneumococcal vaccination; 3. Use of any investigational or non-registered product (drug or vaccine) during the period starting 30 days before the administration of study vaccine (Day -29 to Day 0), or planned use during the study period other than the study vaccine; 4. Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe (eg., coagulation abnormalities). 5. Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs or any blood products during the period starting 30 days prior to the proposed first vaccine dose or planned administration of the same during the study period. 6. Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device). 7. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). 8. Family history of congenital or hereditary immunodeficiency. 9. History of allergic disease or history of a serious reaction to any prior vaccination or known hypersensitivity likely to be exacerbated by any component of the study vaccines. 10. History of any neurological disorders, meningitis or seizures. 11. Infant who has had a family history of a sibling die of sudden infant death syndrome (SIDS) or die suddenly and without apparent other cause or preceding illness in the first year of life. 12. Infant is a direct descendant (child or grand-child) of any person employed by the Sponsor, the Contract Research Organization (CRO) or the Study Site (including the PI and study site personnel). 13. Acute disease and/or fever at the time of vaccination. 14. Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination and Principal investigator judgement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Proportion of subjects with solicited local and systemic adverse reactions 2.Proportion of subjects with unsolicited local and systemic adverse events (AEs) 3.Serious adverse events (SAEs) and medically attended adverse events (MAAE) if anyTimepoint: 1. during first 60 minutes of post vaccination observation period and for subsequent 7 consecutive days (Day 0-6) thereafter 2.during the total post vaccination follow up period till day 84. 3.during the total 84 days of study period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects achieving seroconversionTimepoint: At day 84 post (28 days post third dose of the vaccination);Proportion of subjects achieving =2-fold and =4-fold increase in serotype specific anti-PnCPS IgG antibody titreTimepoint: At day 84 post (28 days post third dose of the vaccination);Geometric mean titre (GMT) of serotype specific anti-PnCPS IgG antibodiesTimepoint: At day 84 post (28 days post third dose of the vaccination);Geometric Mean Fold Rise (GMFR) in serotype specific anti-PnCPS IgG titresTimepoint: At day 84 post (28 days post third dose of the vaccination) | — |
Countries
India
Contacts
Public ContactMr Subba Reddy GV
Biological E.Limited
Outcome results
None listed