Pneumonia Clinical Trial
— PREVAILOfficial title:
Evaluating Pneumococcal Conjugate Vaccine (PCV) Impact on Pneumonia and Pneumococcal Carriage Outcomes in India in Children 1-35 Months in India: Pneumonia Research and Vaccine Impact League
NCT number | NCT03900520 |
Other study ID # | 11740 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 13, 2020 |
Est. completion date | September 30, 2023 |
Verified date | October 2023 |
Source | Johns Hopkins Bloomberg School of Public Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 6004 |
Est. completion date | September 30, 2023 |
Est. primary completion date | November 18, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Month to 35 Months |
Eligibility | PREVAIL-Pneumo: Inclusion criteria: - Age 1-35 months - Admitting diagnosis is pneumonia or lower respiratory tract illness/infection Written informed consent obtained from parent or legally authorized representative Exclusion criteria: - Discharged as an PREVAIL case in the last 90 days PREVAIL-Community: Inclusion criteria: - Age 1-35 months with no systemic illness (mild respiratory illness is not an exclusion criteria) - Written informed consent obtained from parent or legally authorized representative Exclusion criteria: - 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: Inclusion criteria: - Currently enrolled into the PREVAIL study |
Country | Name | City | State |
---|---|---|---|
India | Maulana Azad Medical College | New Delhi |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins Bloomberg School of Public Health | Maulana Azad Medical College, Pfizer |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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) | |
Primary | 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 | Pneumonia-Related Occurance of Illness | Difference in occurrence of illnesses within 3 months of hospital discharge among children 1-35 months presenting with pneumonia at sites that have introduced PCV into the national immunization schedule versus cases enrolled at sites that have not introduced PCV. (3 months refers to the duration each patient would be followed up for following discharge from the hospital) | 2 years (2 year period mentioned refers to the duration of the proposed study in total) | |
Secondary | Pneumonia-Related Mortality | Difference in mortality within 3 months of hospital discharge among children 1-35 months presenting with pneumonia at sites that have introduced PCV into the national immunization schedule versus cases enrolled at sites that have not introduced PCV. (3 months refers to the duration each patient would be followed up for following discharge from the hospital) | 2 years (2 year period mentioned refers to the duration of the proposed study in total) | |
Secondary | Radiographic pneumonia | Proportion of children with primary-end point pneumonia detected on radiography, at sites that have introduced PCV into the national immunization schedule versus cases enrolled at sites that have not introduced PCV. | 2 years (2 year period mentioned refers to the duration of the proposed study in total) | |
Secondary | Hypoxic Pneumonia | Proportion of children with hypoxemic (oxygen saturation<90 percent) among hospitalized pneumonia cases 1-35 months at sites that have introduced PCV versus cases enrolled at sites that have not introduced PCV. | 2 years (2 year period mentioned refers to the duration of the proposed study in total) | |
Secondary | Vaccine Effectiveness | Proportion of hospitalized cases 1-35 months that are vaccinated in PCV-using sites (indirect cohort method to assess vaccine effectiveness) between the following groups: (1) Carrying a VT vs. carrying a non-VT serotype, (2) With vs. without alveolar consolidation, (3) With vs. without hypoxemia. | 2 years (2 year period mentioned refers to the duration of the proposed study in total) |
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