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Pneumonia Research and Vaccine Impact League

NCT03900520 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 6004

Last updated 2023-10-11

No results posted yet for this study

Summary

The leading cause of severe respiratory disease and death in young children is Streptococcus pneumoniae (pneumococcus). An estimated one-fifth of global childhood pneumococcal-related deaths occurred in India. The pneumococcal conjugate vaccine (PCV) is a primary prevention tool against pneumococcal disease that is safe and effective and has been in use in many countries. In alignment with the Government of India's rollout of PCV sub-nationally in selected districts and states, this two-year observational study will use a non-interventional, observational prospective study design to evaluate the impact of PCV in 7 sites in India (5 hospitals and 2 community sites) by assessing clinical and serotype-specific outcomes that include hospitalized pneumonia and community pneumococcal carriage. A sub-study to assess the cost of illness of pneumonia will also be conducted. This study is anticipated to provide data to support sustainability of PCV expansion and disease surveillance in India.

Conditions

Sponsors & Collaborators

  • Maulana Azad Medical College

    collaborator OTHER

  • Pfizer

    collaborator INDUSTRY

  • Johns Hopkins Bloomberg School of Public Health

    lead OTHER

Principal Investigators

  • Anita Shet, MD, PhD · Johns Hopkins Bloomberg School of Public Health

Eligibility

Min Age
1 Month
Max Age
35 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-13
Primary Completion
2022-11-18
Completion
2023-09-30

Countries

  • India

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03900520 on ClinicalTrials.gov