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Pneumococcal Infections clinical trials

View clinical trials related to Pneumococcal Infections.

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NCT ID: NCT04379713 Completed - Clinical trials for Pneumococcal Disease

20-valent Pneumococcal Conjugate Vaccine Safety Study in Healthy Infants

Start date: May 21, 2020
Phase: Phase 3
Study type: Interventional

This study is designed to evaluate the safety and tolerability of 20vPnC in healthy infants.

NCT ID: NCT04214444 Recruiting - Clinical trials for Pneumococcal Infections

Evaluation of Prime-boost Anti-pneumococcal Vaccination in Patients With Diffuse Large B Cell Lymphoma Treated With Rituximab

EVAPOR
Start date: July 3, 2020
Phase: Phase 3
Study type: Interventional

Pneumococcal infections remain frequent and potentially fatal. To prevent them, two anti-pneumococcal vaccines exist: a 13-valent conjugate vaccine (Prevenar®) and a 23-valent polysaccharide vaccine (Pneumovax®). For their utilization, several studies approved a prime-boost strategy. It consist two administer Pneumovax® at least two months later than Prevenar®. Patients with diffuse large B-cell Lymphoma (DLBCL) have a higher-risk to develop a pneumococcal infection. The main reason is immunosuppression, induced by rituximab (B cell depletion), chemotherapy and lymphoma. Patients are treated by immunochemotherapy, combining rituximab (anti-CD20 monoclonal antibody) and conventional chemotherapy (CHOP). However, those patients have a low rate of vaccination (about 15%).

NCT ID: NCT04183322 Completed - Clinical trials for Pneumococcal Infections

PCV13 in Non-pregnant Papua New Guinean Women

Start date: May 10, 2016
Phase:
Study type: Observational

This is an observational study to determine the reactogenicity and immunogenicity of pneumococcal conjugate vaccine in non-pregnant women of reproductive age in Papua New Guinea.

NCT ID: NCT04100772 Completed - Clinical trials for Bacterial Infections

Phase I Clinical Trial of a Candidate PCV13 in Healthy People Aged 6 Weeks and Above

PICTPCV13i
Start date: May 18, 2020
Phase: Phase 1
Study type: Interventional

Streptococcus pneumoniae is a major cause of morbidity and mortality in children worldwide, resulting in up to 1 million pediatric deaths every year.Since the licensure of PCV7 and PCV13,the reported overall decline in invasive pneumococcal disease in hospitalized children younger than 5 years several years is approximately 60% in Western countries.This is a single center,blind, randomized, positive-controlled clinical trial.The purpose of this study is to preliminary evaluate the safety of PCV13i vaccine in subjects at age of 7 months and above,and to investigate the safety and immunogenicity of PCV13i vaccine at age of 2 and 3 months,compared to PCV13.

NCT ID: NCT04031846 Completed - Clinical trials for Pneumococcal Infections

Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-025)

PNEU-PED-EU-1
Start date: September 4, 2019
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety and tolerability and immunogenicity of V114 when administered to 2-month old infants. The primary hypotheses are: 1) V114 is non-inferior to Prevenar 13™ for the 13 shared serotypes between V114 and Prevenar 13™ based on response rates at 30 days post toddler dose (PTD); 2) V114 is superior to Prevenar 13™ for the 2 serotypes unique to V114 based on the response rates at 30 days PTD; 3) V114 is non-inferior to Prevenar 13™ for the 13 shared serotypes between V114 and Prevenar 13™ based on anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobin G (IgG) geometric mean concentrations (GMCs) at 30 days PTD; and 4) V114 is superior to Prevenar 13™ for the 2 serotypes unique to V114 based on anti-PnPs serotype-specific IgG GMCs at 30 days PTD.

NCT ID: NCT04016714 Completed - Clinical trials for Pneumococcal Infections

Safety, Tolerability, and Immunogenicity of a 3-dose Regimen of V114 in Healthy Infants (PNEU-PED-EU-2/V114-026)

PNEU-PED-EU-2
Start date: August 28, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this clinical study is to evaluate the safety and immunogenicity of a 3-dose schedule (2-dose primary series followed by a toddler dose) of pneumococcal conjugate vaccine (PCV) as one of the currently recommended schedules by the World Health Organization (WHO) Strategic Advisory Group of Experts (SAGE) on Immunizations and practiced in many countries. The primary hypotheses are that V114 is non-inferior to Prevenar 13™ for the 13 shared serotypes based on response rates and on anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) at 30 days following Dose 3; that V114 is superior to Prevenar 13™ for the 2 serotypes unique to V114 based on the response rates and on anti-PnPs serotype-specific IgG GMCs at 30 days following Dose 3; and that Vaxelis™ administered concomitantly with V114 is non-inferior to Vaxelis™ administered concomitantly with Prevenar 13™ at 30 days following Dose 3 for each antigen included in Vaxelis™.

NCT ID: NCT03983616 Recruiting - Clinical trials for Pneumococcal Infections

Surveillance of Invasive Pneumococcal Infections in Adults (Excluding Meningitis)

SIIP
Start date: April 2014
Phase:
Study type: Observational

Given the frequency and severity of invasive pneumococcal infections and questions about the place of VPC-13 in the prevention of pneumococcal infections in adults based on the presence of risk factors, current laboratory surveillance should be supplemented with data on the clinical features of adult invasive pneumococcal infections (IPI) cases. In particular it is necessary to collect for these cases, the clinical forms, the severity and the existence of risk factors and to make the link between these characteristics and those strains of pneumococci responsible for the IPI in particular, their serotype. The follow-up of the evolution of the cases according to the presence of risk factors, their clinical form and their serotype coverage (vaccine strain or not) must to guide recommendations for adult VPC-13 and to monitor the effects of VPC-13 vaccination recommendations. These effects are indirect, linked to the effect of vaccination of children with VPC-13 since 2010, which modifies the serotypes responsible for infections in vaccinated and unvaccinated patients, and the direct effects of possible use of the conjugate vaccine in adults (according to the recommendations that will be given by the Vaccination Technical Committee of the High Council of Public Health). The project is based on the existing network of 23 Regional Pneumococcal Observatories (ORP) located in metropolitan France and the network of infectious diseases by completing the microbiological collection of strains of pneumococci isolated from invasive infections in adults by a clinical collection in hospitals or voluntary clinics where the laboratory participates in the ORP. Given the establishment in 2012 of an adult bacterial meningitis observatory, to which the ORP are associated, this project does not include the surveillance of pneumococcal meningitis in adults.

NCT ID: NCT03950856 Completed - Clinical trials for Pneumococcal Infections

Lot-to-Lot Consistency of V114 in Healthy Adults (V114-020)

PNEU-TRUE
Start date: June 12, 2019
Phase: Phase 3
Study type: Interventional

The primary objectives are to evaluate the safety and tolerability of V114 and to compare the serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) across 3 different lots of V114. The primary hypothesis is that all 3 lots of V114 are equivalent as measured by the serotype-specific OPA GMTs for 15 serotypes in V114 at 30 days postvaccination.

NCT ID: NCT03950622 Completed - Clinical trials for Pneumococcal Infections

Safety and Immunogenicity of V114 in Healthy Adults (V114-019/PNEU-AGE)

PNEU-AGE
Start date: June 13, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to 1) evaluate the safety and tolerability of V114 and 2) to compare the immune responses of the 15 serotypes contained in V114 with V114 versus Prevnar 13™. The primary hypotheses are that 1) V114 is noninferior to Prevnar 13™ as measured by the serotype specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) for 13 shared serotypes at 30 days postvaccination and that 2) V114 is superior to Prevnar 13™ as measured by serotype-specific OPA GMTs for 2 unique serotypes in V114 at 30 days postvaccination.

NCT ID: NCT03921424 Completed - Clinical trials for Pneumococcal Infections

Safety and Immunogenicity of V114 in Children Infected With Human Immunodeficiency Virus (HIV) (V114-030/PNEU-WAY PED)

PNEU-WAY PED
Start date: November 5, 2019
Phase: Phase 3
Study type: Interventional

This is a study of V114 in children infected with HIV. Participants will be randomly assigned in a 1:1 ratio to receive either V114 or Prevnar 13™ followed 8 weeks later by a single dose of PNEUMOVAX™23. The primary objectives of this study are to evaluate the safety and tolerability of V114 in children 6 to 17 years of age inclusive infected with HIV and to evaluate the anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 30 days following vaccination with V114 or Prevnar 13™ by each vaccination group. There are no formal hypotheses.