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A long term safety follow-up study for subjects who received 3 doses of Pneumococcal Vaccine.

A Phase-IV multicentre follow-up study to assess the continued safety of Biological E’s 14-valent pneumococcal polysaccharide conjugate vaccine in subjects, who received 3-dose (3 plus 0) primary PCV vaccination as part of BECT051 and BECT061 studies. - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/071627
Enrollment
1590
Registered
2024-07-31
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Z23- Encounter for immunization

Interventions

Intervention1: Pneumococcal polysaccharide Conjugate Vaccine (Adsorbed) (14 Valent)- Single Human dose- 0.5mL: 1. Dose:0.5 mL three dose schedule 2.Frequency: three doses administered 28 days apart do

Sponsors

Biological E.Limited
Lead Sponsor
MS Biological ELimited
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. All Subjects who participated and completed all study related visits and assessments, part of BECT051 and BECT061 studies. 2. Subjects’ parent(s)or LAR(s) who, in the opinion of the investigator, can and will comply, with the requirements of the protocol. 3. Subject’s parent(s)or LAR(s) willing to provide written or thumb printed informed consent prior to performing any study specific procedure or assessments.

Exclusion criteria

Exclusion criteria: 1. Subjects who dropped out from BECT051 or BECT061 studies. 2. Subjects who participated in another clinical study from the completion of the BECT051 and BECT061 studies until the commencement of current study. 3. Subject 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).

Design outcomes

Primary

MeasureTime frame
1.To assess incidence of adverse events (AEs) in terms of their number and percentage of AEs experienced by BE-PCV14 and PCV-13 vaccinated subjects 2.To assess medically attended adverse events (MAAEs), if any, in terms of their number and percentage of AEs experienced BE-PCV14 and PCV-13 vaccinated subjectsTimepoint: 1.From day 86 (30 days’ post last dose) till the day of the study visit (enrolment) in the current safety follow-up study. 2.From day 86 (30 days’ post last dose) till the day of the study visit (enrolment) in the current safety follow-up study.—

Secondary

MeasureTime frame
NoneTimepoint: None—

Countries

India

Contacts

Public ContactMr Subba Reddy GV

Biological E.Limited

subhash.thuluva@biologicale.com04071216248

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026