Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/CTRI/2020/02/023129
CTRI/2020/02/023129CompletedPhase 3

A single blind randomised active-controlled Phase-III study to evaluate immunogenicity, safety, tolerability of a candidate 14-valent pneumococcal polysaccharide conjugate vaccine administered to 6-8 weeks old healthy Indian Infants in 6-10-14 weeks dosing schedule. - None

Biological E Limited0 sites1,290 target enrollmentStarted: TBDLast updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
1,290
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Inclusion Criteria

  • •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
  • •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).

Exclusion Criteria

  • •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
  • •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.

Investigators

Similar Trials

Active, not recruiting
Phase 3
A clinical study to assess the immunogenicity, safety & tolerability of BEs Pneumococcal conjugate vaccine when administered in a two plus one dosing schedule.
CTRI/2022/11/047366Biological E Limited
Completed
Phase 3
A clinical study to assess the safety & immune response of BEs Pneumococcal conjugate vaccine when administered in a three dose schedule.
CTRI/2021/10/037067Biological ELimited300
Active, not recruiting
Not Applicable
Single blind, randomized, active controlled Phase 1/2 study to compare the safety and immunogenicity of a Split Virus, Vero cell-derived, seasonal influenza vaccine (VCIV) with a licensed egg-derived, Split Virus, seasonal influenza vaccine (EIV) - Phase 1/2 Split Virus Influenza Vaccine TrialInfluenza Vaccination in healthy subjects
EUCTR2006-005191-41-ATBaxter Healthcare Corporation, Baxter BioScience1,000
Active, not recruiting
Not Applicable
Single blind, randomized, active controlled Phase 1/2 study to compare the safety and immunogenicity of a Split Virus, Vero cell-derived, seasonal influenza vaccine (VCIV) with a licensed egg-derived, Split Virus, seasonal influenza vaccine (EIV) - Phase 1/2 Split Virus Influenza Vaccine TrialInfluenza Vaccination in healthy subjects
EUCTR2006-005191-41-DEBaxter Healthcare Corporation, Baxter BioScience1,000
Completed
Phase 1
A Phase I Clinical Study to assess the Safety and Tolerability of SII Typhoid Conjugate Vaccine (Bivalent) in Healthy Adults
CTRI/2022/06/043608Serum Institute of India Pvt Ltd60