Pneumonia Research and Vaccine Impact League

NCT03900520 | Completed

• 1 other identifier: 11740
• Study Type: observational
• Target: 6,004
• Locations: 1 country
• Sites: 1

Brief 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

Pneumonia

Keywords

pneumococcal conjugate vaccine; vaccine impact; radiographic pneumonia; hospitalization; nasopharyngeal swab; India; cost of illness; pneumococcal carriage; pneumococcal serotypes; pneumonia

Outcome Measures

Primary Outcomes (3)

• Pneumonia colonized by vaccine-type Streptococcus pneumoniae

  PREVAIL-Pneumo: Proportion of children with physician-diagnosed pneumonia that are colonized in the nasopharynx with 'vaccine-type' pneumococcus among sites where PCV has been introduced compared to sites where PCV has not been introduced (includes 13 serotypes included in the 13-valent pneumococcal conjugate vaccine)

  2 years (2 year period mentioned refers to the duration of the proposed study in total)

• Community carriage of vaccine-type Streptococcus pneumoniae

  PREVAIL-Community: Proportion of community children that are colonized in the nasopharynx with 'vaccine-type' pneumococcus enrolled at a site that has introduced PCV into the NIP compared to children enrolled at a site that has not introduced PCV (includes 13 serotypes included in the 13-valent pneumococcal conjugate vaccine)

  2 years (2 year period mentioned refers to the duration of the proposed study in total)

• Pneumonia and IPD cost of illness

  PREVAIL-Econ: Determine the overall economic impact of PCV, including direct and indirect costs, both during hospitalization and longer-term expenditures at 3 months post hospitalization

  1 years (1 year period mentioned refers to the duration of the proposed study in total)

Secondary Outcomes (5)

• Pneumonia-Related Occurance of Illness

  2 years (2 year period mentioned refers to the duration of the proposed study in total)

• Pneumonia-Related Mortality

  2 years (2 year period mentioned refers to the duration of the proposed study in total)

• Radiographic pneumonia

  2 years (2 year period mentioned refers to the duration of the proposed study in total)

• Hypoxic Pneumonia

  2 years (2 year period mentioned refers to the duration of the proposed study in total)

• Vaccine Effectiveness

  2 years (2 year period mentioned refers to the duration of the proposed study in total)

Study Arms (3)

Pneumonia group (PREVAIL-Pneumo)

Children aged 1-35 months with pneumonia or lower respiratory tract infection hospitalized or recommended for hospitalization

Community group (PREVAIL-Community)

Children aged 1-35 years living in the community with no known systemic illness

Economic group (PREVAIL-Econ)

PREVAIL-Pneumo-enrolled children hospitalized for pneumonia

Eligibility Criteria

• Age: 1 Month - 35 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

There are three cohorts/groups that are recruited: PREVAIL-Pneumo: Cases aged 1-35 months of age hospitalized with physician-diagnosed pneumonia or lower respiratory tract infection. PREVAIL-Community: Children 1-35 months of age residing in the community with no systemic illness and randomly selected for inclusion into this group PREVAIL-Econ: A subset of cases enrolled into the PREVAIL-Pneumo study

You may qualify if:

• Age 1-35 months
• Admitting diagnosis is pneumonia or lower respiratory tract illness/infection Written informed consent obtained from parent or legally authorized representative

You may not qualify if:

• Discharged as an PREVAIL case in the last 90 days
• PREVAIL-Community:
• Written informed consent obtained from parent or legally authorized representative
• Known underlying serious disease (e.g., congenital heart diseases, immunodeficiency disorders, sickle cell anemia etc.) which may negatively influence the participant's ability to participate in the study
• PREVAIL-Econ:
• Currently enrolled into the PREVAIL study

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Maulana Azad Medical College: collaborator
• Pfizer: collaborator

Study Sites (1)

Maulana Azad Medical College

New Delhi, India

Location

Biospecimen

Retention: SAMPLES WITH DNA

Nasopharyngeal swab

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Anita Shet, MD, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 3, 2019
• Study Start: October 13, 2020
• Primary Completion: November 18, 2022
• Study Completion: September 30, 2023
• Last Updated: October 11, 2023

Record last verified: 2023-10

Locations

IN (1)