A clinical trial to study the effect of reduced and alternate dose schedule of already approved pneumococcal conjugate vaccine

Phase 4

Completed

• Registration Number: CTRI/2016/06/007042
• Lead Sponsor: KEM Hospital Research Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-05-22
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 805

Inclusion Criteria

• Healthy infants as established by medical history and clinical examination

• 6-8 weeks of age at the time of enrolment.

• Written informed consent obtained from the parent(s) of infants

• Parent who intends to remain in the area with the child during the study period.

Exclusion Criteria

• Acute disease at the time of enrolment (temporary exclusion)

• Concurrent participation in another clinical trial during study period.

• Presence of significant malnutrition (weight-for-height z-score <-3SD median)

• Presence of significant systemic disorder as determined by medical history and/or physical examination

• Prior receipt of pneumococcal vaccine

• Known sensitivity or allergy to any components of the study vaccine

• Major congenital or genetic defect

• Has received any immunoglobulin therapy and/or blood products since birth or planned administration during the study period.

• History of chronic administration (defined as more than 14 days) of immune-suppressants including corticosteroids.

• Any medical condition in the subject, which, in the judgment of the investigator, would interfere with protocol adherence or participantâ??s parentsâ?? ability to give informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified