A clinical study to assess the safety & immune response of BEs Pneumococcal conjugate vaccine when administered in a three dose schedule.
- Conditions
- Health Condition 1: Z23- Encounter for immunization
- Registration Number
- CTRI/2021/10/037067
- Lead Sponsor
- Biological ELimited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 300
1. Healthy pneumococcal conjugate vaccine-naïve (PCV-naive) infants as established by medical history and 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 1st dose of vaccination.
3. Healthy Infants with 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 dose of BCG, Hepatitis B &/or Polio vaccine at the time of enrolment).
1. Child in care, defined as a child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation. The definition of a child in care can include a child cared for by foster parents or living in a care home or institution, provided that the arrangement falls within the definition above. The definition of a child in care does not include a child who is adopted or has an appointed legal guardian.
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 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.
Fever is defined as the endogenous elevation of at least one measured body temperature of = 38?C (= 100.4?F).
14. Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination and Principal investigator judgement.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Proportion of subjects with solicited local and systemic adverse reactions/events <br/ ><br>2.Proportion of subjects with unsolicited systemic adverse events (AEs) <br/ ><br>3.Medically attended adverse events and serious adverse events (SAEs), if anyTimepoint: 1.during first 60 minutes of post vaccination observation period and for subsequent 7 <br/ ><br>consecutive days <br/ ><br>2. during the total post vaccination follow up period. <br/ ><br>3.during the total study period
- Secondary Outcome Measures
Name Time Method Anti-PnCPS IgG Geometric Mean ConcentrationsTimepoint: At 1 month after 3rd dose, against baseline;In subjects already baseline seroconverted (= 0.35 µg/ml), percentage of subjects with =4-fold rise in serotype specific anti-PnCPS IgG antibody concentrationTimepoint: From their baseline;The percentage of subjects with anti-PnCPS IgG concentration = 0.35 µg/ml (as measured by ELISA) against each of the vaccine serotypeTimepoint: At 1 month after 3rd dose, against baseline.;The percentage of subjects with =2-fold and =4-fold rise in anti-PnCPS IgG ConcentrationsTimepoint: From baseline, at 1 month after 3rd dose