PCV13 Impact on Pneumococcal Nasopharyngeal Carriage Study

Launched by ASIAN FOUNDATION FOR TROPICAL MEDICINE INC. · Oct 29, 2021

Keywords

ClinConnect Summary

The PCV13 Impact on Pneumococcal Nasopharyngeal Carriage Study is a clinical trial designed to understand how a vaccine called PCV13 affects the presence of certain bacteria in the nose and throat of young children who have been hospitalized with community-acquired pneumonia (CAP). The study focuses on Filipino children between 8 weeks and 60 months old. Researchers will compare children who have received the vaccine to those who have not to see how well it works in preventing these infections.

To participate, children must be between 8 weeks and 5 years old, live in specific areas of the Philippines, and have been diagnosed with pneumonia. They also need to have received at least one dose of the PCV13 vaccine before turning one year old. However, children with certain health conditions or previous vaccinations may not be eligible. Participants will undergo a simple test to check for the bacteria in their nose and throat. This study is currently active, meaning it’s ongoing but not recruiting new participants at this time. It aims to gather important information that could help improve treatments and prevent pneumonia in young children.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Child 8 weeks to ≤60 months of age
• • 2. Resident of the National Capital Region (NCR) or Region X-XIII
• • 3. Child admitted with a medical diagnosis of clinical CAP based on history and physical exam
• • 4. Written informed consent obtained from a parent or legal guardian
• • 5. At SPMC site, child must have received at least 1 dose of PCV13 given at \<12 months based on history-taking
• • 6. For Phase B at PCMC site, child must have received at least 1 dose of PCV13 given at \<12 months based on history-taking
• Exclusion Criteria:
• • 1. Children with a known primary or secondary immunodeficiency
• • 2. Child with a contraindication to doing a nasopharyngeal swab which may include, but is not limited to: dyscrasias, coagulation disorders, or other diseases (e.g., hemophilia, purpura), presence of craniofacial abnormalities32
• • 3. For Phase A at PCMC site, child with any PCV in the past based on history-taking