A long term safety follow-up study for subjects who received 3 doses of Pneumococcal Vaccine.
- Conditions
- Health Condition 1: Z23- Encounter for immunization
- Registration Number
- CTRI/2024/07/071627
- Lead Sponsor
- Biological E.Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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.
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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 <br/ ><br>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. <br/ ><br>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 Outcome Measures
Name Time Method oneTimepoint: None