A clinical study to assess the safety,tolerability & over all immune response of BEsPneumococcal conjugate vaccine when administered in a three dose schedule.
- Conditions
- Health Condition 1: Z23- Encounter for immunization
- Registration Number
- CTRI/2020/02/023129
- Lead Sponsor
- Biological E Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1290
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.
o 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.The percentage of subjects with anti-PnCPS IgG concentration = <br/ ><br>0.35 µg/ml (as measured by ELISA) against each of the vaccine <br/ ><br>serotype with their exact 2-sided 95% confidence intervals <br/ ><br>2.Anti-PnCPS IgG Geometric Mean Concentrations and their <br/ ><br>Geometric mean ratio (BE-PCV14/Prevenar 13) against each of <br/ ><br>the 12 common vaccine serotypes with their exact 2-sided 95% <br/ ><br>CIs.Timepoint: 1.at 1 month <br/ ><br>after three <br/ ><br>doses. <br/ ><br>2.at 1 month <br/ ><br>after three <br/ ><br>doses
- Secondary Outcome Measures
Name Time Method GMFR in antibody titres against each of the <br/ ><br>vaccine serotypeTimepoint: From pre vaccination levels;IgG conc. will be determined by ELISA and <br/ ><br>functional antibodies by OPA will be <br/ ><br>evaluated for 12 common serotypes of 14- <br/ ><br>valent PCV.Timepoint: At 1 month after 3 doses;OPA GMFR against each of the vaccine <br/ ><br>serotype.Timepoint: From pre vaccination levels;Percentage of subjects with =4-fold rise in serotype <br/ ><br>specific antibody concentration.Timepoint: From the baseline;Proportion of subjects with solicited local <br/ ><br>and systemic adverse reactions/events.Timepoint: during first 60 minutes of post <br/ ><br>vaccination observation period and <br/ ><br>for subsequent 7 consecutive days;Proportion of subjects with unsolicited <br/ ><br>systemic adverse events (AEs).Timepoint: during the total post vaccination <br/ ><br>follow up period