Pneumonia Research and Vaccine Impact League (NCT03900520) | Clinical Trial Compass
CompletedNot Applicable
Pneumonia Research and Vaccine Impact League
India6,004 participantsStarted 2020-10-13
Plain-language 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.
Who can participate
Age range
1 Month – 35 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pneumonia colonized by vaccine-type Streptococcus pneumoniae
Timeframe: 2 years (2 year period mentioned refers to the duration of the proposed study in total)
2
Community carriage of vaccine-type Streptococcus pneumoniae
Timeframe: 2 years (2 year period mentioned refers to the duration of the proposed study in total)
3
Pneumonia and IPD cost of illness
Timeframe: 1 years (1 year period mentioned refers to the duration of the proposed study in total)
Trial details
NCT IDNCT03900520
SponsorJohns Hopkins Bloomberg School of Public Health