Pneumonia, Pneumococcal Clinical Trial
Official title:
A Phase 3 Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-Experienced Adults 50 Years of Age or Older
This a study of V116 in adults ≥50 years of age who previously received a pneumococcal vaccination ≥1 year before enrollment. The primary objectives of this study are to evaluate the safety, tolerability, and immunogenicity of V116.
Participants will be randomized to 1 of 3 cohorts depending upon prior vaccinations. Prior vaccinations by cohort include: PPSV23 (pneumococcal vaccine, polyvalent [23-valent], PNEUMOVAX™23) for Cohort 1; PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) for Cohort 2; PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™), PCV20 (pneumococcal 20-valent conjugate vaccine; PREVNAR 20™), PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 for Cohort 3. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05799976 -
Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure
|
N/A | |
| Completed |
NCT05526716 -
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 When Administered Concomitantly With Influenza Vaccine in Adults 50 Years of Age or Older (V116-005, STRIDE-5)
|
Phase 3 | |
| Completed |
NCT02116998 -
Safety, Tolerability, and Efficacy Study of Prophylactic S. Pneumoniae Vaccine Following Challenge With S. Pneumoniae
|
Phase 2 | |
| Completed |
NCT00744263 -
Study Evaluating the Effiacy of a 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) in Adults
|
Phase 4 | |
| Completed |
NCT04559204 -
Evaluation of Safety and Immunogenicity of Combined Immunization of PPV23 and IIV4
|
Phase 4 | |
| Active, not recruiting |
NCT04923035 -
Paediatric Pneumococcal Pneumonia in Malaysia Prior to and During Pneumococcal Conjugate Vaccine (PCV) Implementation
|
||
| Completed |
NCT02961231 -
Evaluation of PCV Schedules in a Naive Population in Vietnam
|
Phase 4 | |
| Completed |
NCT03460730 -
Dynamics of the Immune Response in Children to the 23-valent Pneumococcal Capsular Polysaccharide Vaccine (Pneumovax)
|
Phase 1 | |
| Recruiting |
NCT06136832 -
Pneumonia Vaccine Education Intervention Study
|
N/A | |
| Active, not recruiting |
NCT05079152 -
Evaluation of Immunogenicity and Safety of Combined Immunization of COVAX (Produced in Wuhan) and PPV23 / IIV4
|
Phase 4 | |
| Completed |
NCT04790851 -
Evaluation of Immunogenicity and Safety of Combined Immunization of COVID-19 Vaccine (Produced in Beijing) and PPV23 / IIV4
|
Phase 4 | |
| Terminated |
NCT03058211 -
Myocardial Injury and Severe Pneumococcal Pneumonia
|
||
| Recruiting |
NCT04108845 -
Safety Study of 15-Valent Pneumococcal Conjugate Vaccine in Healthy Volunteers Aged Above 2 Months
|
Phase 1 | |
| Completed |
NCT03197376 -
Phase 3 Study of 10-valent Pneumococcal Conjugate Vaccine (PNEUMOSIL) in Healthy Infants
|
Phase 3 | |
| Recruiting |
NCT05412030 -
A Phase 2 Study to Evaluate the Safety, Tolerability, and Immunogenicity of AFX3772 Vaccine in Healthy Infants
|
Phase 2 | |
| Completed |
NCT03950856 -
Lot-to-Lot Consistency of V114 in Healthy Adults (V114-020)
|
Phase 3 | |
| Completed |
NCT04464291 -
An Epidemiological Survey to Establish the Spectrum of Circulating Serotypes of S. Pneumoniae, in Patients Older 18 Years
|
N/A | |
| Not yet recruiting |
NCT04357522 -
Immunogenicity and Safety Study of 15-Valent Pneumococcal Conjugate Vaccine in 2-month-old and 3-month-old Healthy Volunteers
|
Phase 3 | |
| Completed |
NCT03896477 -
Study of 10-valent Pneumococcal Conjugate Vaccine (Pneumosil) Administered in a 2+1 Schedule to Healthy Infants
|
Phase 3 | |
| Completed |
NCT04278248 -
Immunogenicity and Safety of 23-Valent Pneumococcal Polysaccharide Vaccine in Healthy Volunteers Aged 2 Years and Above
|
Phase 3 |