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Pneumococcal Infections clinical trials

View clinical trials related to Pneumococcal Infections.

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NCT ID: NCT05875727 Completed - Clinical trials for Pneumococcal Disease

A Study to Learn About the Safety and Immune Response of 20vPnC in Adults in India.

Start date: August 16, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to learn about the safety and immune response of 20vPnC in adults in India. This study is seeking participants who: - are generally healthy adults of 18 years or older. - have not received pneumococcal vaccine. The study will have 2 groups based on age. One group will have particpants between 18 to 49 years of age. The other group will have participants of 50 years or older. Participants will take part in the study for about one month which includes two visits to the study clinic. Participants will receive a single dose of study vaccine (20vPnC) into the arm at visit 1 and will come to study site for a follow-up visit after about a month. The study team will ask questions about the participant's health and blood samples will be taken in a subset of participants during the visits.

NCT ID: NCT05731115 Completed - Clinical trials for Pneumococcal Infections

Lot-to-lot Consistency of 23-valent Pneumococcal Polysaccharide Vaccine

Start date: February 27, 2023
Phase: Phase 4
Study type: Interventional

This study is a randomized, double-blind phase Ⅳ clinical trial of 23-valent pneumococcal polysaccharide vaccine manufactured by Sinovac Biotech Co., Ltd.The purpose of this study is to evaluate the consistency of three consecutive lots, immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine of commercial scale in participants aged 40-65 years.

NCT ID: NCT05696080 Completed - Clinical trials for Pneumococcal Infection

Safety and Immunogenicity of V116 in Adults With Increased Risk for Pneumococcal Disease (V116-008)

STRIDE-8
Start date: February 13, 2023
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are to evaluate the safety and tolerability of the pneumococcal 21 valent conjugate vaccine (V116), and to evaluate the serotype-specific opsonophagocytic activity (OPA) post-vaccination with V116 and PCV15 (a pneumococcal conjugate vaccine that includes 15 serotypes) + PPSV23 (comprised of the polysaccharides from 23 of the serotypes causing disease in adults) post-vaccination. within each vaccination group separately.

NCT ID: NCT05633992 Completed - Clinical trials for Pneumococcal Disease

Safety and Immunogenicity of V116 in Vaccine-naïve Japanese Older Adults (V116-009, STRIDE-9)

Start date: January 10, 2023
Phase: Phase 3
Study type: Interventional

This is a phase 3, randomized, double-blind, active comparator-controlled study of the safety, tolerability, and immunogenicity of V116 in pneumococcal vaccine-naïve Japanese adults 65 years of age and older. The polyvalent (23-valent) pneumococcal vaccine, PPSV23, is the active comparator. In addition to studying safety/tolerability, it is hypothesized that, at 30 days postvaccination, the immunogenicity of V116 is noninferior to PPSV23 for the 12 common serotypes in V116 and PPSV23 and the cross-reactive serotype 15B in V116, and that the immunogenicity of V116 is superior to PPSV23 for the unique serotype 15C in V116. It is also hypothesized that V116 is superior to PPSV23 in the percentage of participants with ≥4-fold rise from baseline in the 8 unique V116 serotypes (except for 15C), as measured by serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs).

NCT ID: NCT05489328 Completed - Clinical trials for Pneumococcal Disease

Safety and Immunogenicity of Pneumococcal Conjugate Formulations in Healthy Adults 18 Through 49 Years of Age

Start date: August 15, 2022
Phase: Phase 1
Study type: Interventional

The purpose of the study is to describe the safety and immunogenicity of Pneumococcal Conjugate Formulations in healthy adults 18 through 49 years of age.

NCT ID: NCT05477693 Completed - Clinical trials for Pneumococcal Infections

Immunogenicity and Safety of 23-valent Pneumococcal Polysaccharide Vaccine

Start date: October 25, 2022
Phase: Phase 4
Study type: Interventional

This is a randomized, double-blind, positive-controlled phase Ⅳ clinical trial of 23-valent pneumococcal polysaccharide vaccine manufactured by Sinovac Biotech Co., Ltd.The purpose of this study is to evaluate the immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine in population aged 2 years and older.

NCT ID: NCT05464420 Completed - Clinical trials for Pneumococcal Disease

A Study to Evaluate the Safety, Tolerability, Immunogenicity, and Lot Consistency of V116 in Adults 18 to 49 Years of Age (V116-004, STRIDE-4)

Start date: August 12, 2022
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety, tolerability, and immunogenicity of a pneumococcal 21-valent conjugate vaccine (V116) in pneumococcal vaccine-naïve adults 18 to 49 years of age. The primary study hypothesis is that all 3 lots of V116 are equivalent as assessed by the serotype-specific opsonophagocytic activity (OPA) Geometric Mean Titers (GMTs) at 30 days postvaccination for all serotypes included in V116.

NCT ID: NCT05425732 Completed - Clinical trials for Pneumococcal Infection

Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults (V116-003, STRIDE-3)

Start date: July 13, 2022
Phase: Phase 3
Study type: Interventional

This is a phase 3, randomized, double-blind, active comparator-controlled study of the safety, tolerability, and immunogenicity of V116 compared to PCV20 (pneumococcal 20-valent conjugate vaccine ([Prevnar 20™ / APEXXNAR™]) in pneumococcal vaccine-naïve adults. It is hypothesized that V116 is noninferior to PCV20 for the common serotypes and superior to PCV20 for the unique serotypes as assessed by serotype specific opsonophagocytic activity (OPA) 30 days postvaccination. It is also hypothesized that V116 in participants 18 to 49 years of age immunobridges to V116 in participants 50 to 64 years of age as assessed by serotype specific OPA geometric mean titers (GMTs) 30 days postvaccination for all 21 serotypes in V116. Participants ≥50 years of age will be enrolled in Cohort 1, and participants 18 to 49 years of age will be enrolled in Cohort 2.

NCT ID: NCT05408429 Completed - Clinical trials for Pneumococcal Disease

Safety and Immunogenicity of 20vPnC in Toddlers With 2 Prior Doses of Prevenar 13

Start date: June 24, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to understand the safety and effects of a study vaccine (20vPnC) in toddlers who had 2 prior doses of Prevnar 13. This study is being conducted in children who: - are between 12 to 23 months of age; - are healthy as determined by the study doctors; - have received 2 doses of Prevnar 13 during the first year in life. Participants in this study will receive either 1 dose or 2 doses of the study vaccine or 1 dose of Prevnar 13 as a shot in the muscle. During the study, participants will have to come to the study clinic to receive the vaccines and have blood sample collected. The study team will work with participants' parents or legal guardians to monitor any unwanted reactions to the vaccines. Participants are expected to take part in this study for about 1 or 3 months, for 1 dose or 2 dose schedules, respectively.

NCT ID: NCT05393037 Completed - Clinical trials for Pneumococcal Disease

Safety and Immunogenicity of V116 in Adults Living With Human Immunodeficiency Virus (HIV) (V116-007, STRIDE-7)

Start date: July 13, 2022
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety, tolerability, and immunogenicity of a pneumococcal 21-valent conjugate vaccine (V116) in persons living with human immunodeficiency virus (HIV), for the prevention of pneumococcal disease caused by the serotypes in the vaccine.