A clinical study to assess the safety of BEs Pneumococcal conjugate vaccine when administered in a three dose schedule.
- Conditions
- Health Condition 1: Z23- Encounter for immunization
- Registration Number
- CTRI/2023/09/057894
- Lead Sponsor
- Biological ELimited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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 (only for Safety arm).
2. Healthy pneumococcal conjugate vaccine-naïve (PCV-naive), Pentavalent vaccine (DTwP-rHepB-Hib) naïve, IPV vaccine naïve and live attenuated
Rotavirus vaccine naïve infants as established by medical history and clinical assessment before entering into the study. PCV/Pentavalent/IPV/Rotavirus vaccine-naïve infants are those who have not been previously vaccinated with any licensed or investigational PCV/Pentavalent/IPV/Rotavirus vaccines (only for immunogenicity arm).
3. Infants between 6-8 weeks of age (42-56 days, both days inclusive) of either gender, at the time of first dose of vaccination.
4. Healthy Infants with body weight = 3300 gms at the time of screening.
5. 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).
6. 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.
7. Infants with a minimal vaccination status for their age at the time of enrolment
(minimal ? defined as single dose of only BCG, Hepatitis B &/or Polio vaccine prior to enrolment).
1.Child in care
2.Evidence of previous Streptococcus pneumoniae infection or pneumococcal vaccination.
3.Evidence of previous or intercurrent or known exposure to diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, H. influenzae type b and rotavirus diseases (immunogenicity arm only)
4. 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.
5. Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe (eg., coagulation abnormalities).
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. 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.
8. History of any neurological disorders, meningitis or seizures.
9. 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.
10. 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).
11. 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).
12. 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.Number & proportion of subjects with solicited local & systemic adverse reactions/events <br/ ><br>2.Number & proportion of subjects with unsolicited systemic adverse events (AEs) <br/ ><br>3.Medically attended adverse events (MAAEs), & serious adverse events (SAEs), if anyTimepoint: 1.during first 30 minutes of post vaccination observation period & for subsequent 7 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 umber & proportion of subjects seroconverted (IgA concentrations) <br/ ><br>against Rotavirus vaccineTimepoint: At day 84 from baseline;Number & proportion of subjects seroprotected (IgG concentrations) <br/ ><br>against Pentavalent DTwP-rHepB-HIB and IPVTimepoint: At day 84 from baseline;Number & proportion of subjects with anti-PnCPS IgG concentration = <br/ ><br>0.35 µg/ml (IgG concentrations) against 14 serotypesTimepoint: At day 84 from baseline