Clinical Trials for Pneumococcal Infections

Source: ClinicalTrials.gov — U.S. National Library of Medicine — A database of privately and publicly funded clinical studies conducted around the world (U.S. National Library of Medicine, public domain).

This page lists clinical trials related to Pneumococcal Infections from the ClinicalTrials.gov database.

Trial Summary

• Total studies: 50
• Recruiting: 11
• Active, not recruiting: 11
• Completed: 20
• Other: 8

Results are refreshed periodically and may not reflect the most current information available from ClinicalTrials.gov.

Recruiting Trials

NCT04664569 — National Bacterial Meningitis Study in Children and Newborns

Bacterial meningitis is a major cause of morbidity and mortality in childhood. Antibiotic treatment recommendations are based on epidemiological and susceptibility data. The epidemiology of bacterialméningitis has changed in recent years, mainly owing to widespread use of different conjugate vaccines. The aim of this prospective national survey is to describe epidemiology of bacteria implicated…

NCT04664556 — National, Non Interventional Study of Invasive Pneumococcal Disease in Children and Newborns

After 7 then 13 valent pneumococcal conjugate vaccine (PCV) implementation in France in children, we will evaluate the impact of this vaccination on invasive pneumococcal disease (IPD). We will describe the clinical characteristics of IPD, pneumococcus serotyping, underlying conditions and vaccination status.

NCT05452941 — A Study to Learn About How 20-Valent Pneumococcal Conjugate Vaccine Works in a Real-world Setting

The purpose of this study is to learn about how well the 20-valent pneumococcal conjugate vaccine (20vPnC) works against radiologically-confirmed community-acquired pneumonia (RAD+CAP) due to the 7 new serotypes (types of a bacteria called Streptococcus pneumoniae that cause pneumonia) included in 20vPnC vaccine.

This study is seeking participants who:

• are male or female ≥65 years of age. *…

NCT07017777 — A Study to Evaluate the Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine (PCV13i) in Healthy Infants Aged 2 Months (Minimum 6 Weeks)

This is a Phase 3 randomized, observation-blinded, active-controlled, parallel-group clinical trial designed to evaluate the immunogenicity, safety, and functional antibody response of the experimental vaccine versus the control vaccine in healthy Thailand infants vaccinated at a 2+1 schedule (2 months, 4 months and 12-15 months). The trial will enroll approximately 600 healthy infants aged 2 m…

NCT06822907 — Immunogenicity and Safety PCV-20 of the Vaccine Administered During an Acute Febrile Illness in Adults

Streptococcus pneumoniae is responsible for serious infections associated to numerous hospitalizations and high rate of mortality. The incidence and therefore the burden of pneumococcal infections have been significantly reduced thanks to the use of pneumococcal conjugate vaccines (PCVs). PCVs were shown to be effective against vaccine-type serotypes causing both non-invasive and invasive pneum…

NCT07300267 — A Clinical Study of Novel Pneumococcal Vaccine V118C in Children (V118C-002)

Researchers are looking for new vaccines to prevent pneumococcal disease, which is any infection in the lungs or other parts of the body that is caused by a type of bacteria called Streptococcus pneumoniae. V118C is a new vaccine designed to help prevent disease from Streptococcus pneumoniae bacteria.

This study will look at V118C in toddlers and infants. The goal of the study is to learn how …

NCT07348692 — Lot-to-lot Consistency Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From 2 Months of Age

This is a phase 3 randomized, modified double-blind study whose purpose is to measure whether 3 lots of the investigational pneumococcal vaccine PCV21 can help the body to develop germ-fighting agents called “antibodies” (immunogenicity) in a similar way (ie, same immune response) when they are given to infants aged from approximately 2 months (42 to 89 days) and are safe compared to a licensed…

NCT07135453 — Induction of Cross-protective Antibodies for Serogroup 33 by Pneumococcal Conjugate Vaccines

The goal of this study is to learn whether different types of vaccines to prevent bacterial infections are able to effectively create antibodies that defend against certain types of bacteria.

We will give two different types of vaccine and evaluate the effectiveness of antibodies produced by each vaccine in killing bacteria.

NCT07573462 — A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants

The purpose of this study is to learn about the safety of a new pneumococcal vaccine and how the new pneumococcal vaccine helps to fight against germs that can cause pneumonia (lung infections), meningitis (brain infections), and otitis media (ear infections) in infants when compared to the pneumococcal vaccine that is currently in use, 20vPnC (Prevnar 20®).

This study will test if the new pne…

NCT07629440 — A Study to Learn About How a New Pneumococcal Vaccine Works in Infants.

The purpose of this study is to learn about the safety of a new pneumococcal vaccine and how the new pneumococcal vaccine helps to fight against germs that can cause pneumonia (lung infections), meningitis (brain infections), and otitis media (ear infections) in infants when compared to the pneumococcal vaccine that is currently in use, 20vPnC (Prevnar 20®).

This study will test if the new pne…

NCT07660198 — Study to Learn About Safety, Tolerability, and Immune Response of a Catch-up Pneumococcal Vaccine in Children and Adolescents

The purpose of this study is to learn about the safety of a new pneumococcal vaccine and how the new pneumococcal vaccine helps to fight against germs that can cause pneumonia (lung infections), meningitis (brain infections), and otitis media (ear infections) in children when compared to the pneumococcal vaccine that is currently in use, 20vPnC (Prevnar 20®).

This study will test if the new pn…

Active, Not Recruiting

NCT03729778 — Impact of HIV-1 and Aging on Mucosal Vaccine Responses

The purpose of this study is to learn more about both HIV-1 infection and advancing age, and their association with increased risk of serious infection and impaired response to the Prevnar 13 vaccine.

NCT06524414 — A Study to Learn About How a New Pneumococcal Vaccine Works in Infants

The purpose of this study is to learn about the safety of a new pneumococcal vaccine and how the new pneumococcal vaccine helps to fight against germs in infants when compared to the pneumococcal vaccines that are currently in use, 20vPnC (Prevnar 20®) or another licensed pneumococcal vaccine.

To ensure that the new vaccine (PG4) stays stable, it is placed in a liquid mixture of sterile water …

NCT06720038 — A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 in Healthy Infants

The objective of the study is to evaluate the safety, tolerability, and immunogenicity of 4 injections of VAX-31 (at 4 dose levels) compared to PCV20 in infants at 2, 4, 6, and 12-15 months of age, in addition to receiving routine US concomitant vaccines. Stage 1 of the study will comprise 3 dose ascending cohorts. Stage 2 of the study will enroll approximately 352 subjects. Stage 3 of the stud…

NCT06622109 — A Study to Learn About the Safety of PREVENAR 20 Vaccine in Infants Aged Between Two to Six Months

The purpose of this study is to learn about the safety of 20-valent Pneumococcal Conjugate Vaccine (PREVENAR 20) under actual clinical practice in Japan.

This study is seeking for infants aged between two months to six months who are vaccinated with PREVENAR 20 for the first time.

Infants aged between two months and six months are normally given four vaccinations. The first three vaccinations…

NCT06782282 — A Study to Learn About How Well the Prevnar 20 Vaccine Works for Pneumonia in People Who Are 65 Years and Older

The purpose of this study is to learn about how well the Prevnar 20 vaccine (PCV20) stops invasive pneumococcal disease (a group of severe infections caused by a bacteria called Streptococcus pneumoniae), pneumococcal pneumonia (a bacterial lung disease caused by the germ Streptococcus pneumoniae), all-cause pneumonia (pneumonia caused by any germ including bacteria, a virus, or a fungus), and …

NCT07023081 — A Study to Understand the Safety of the 20vPnC Vaccine in Healthy Chinese Adults, Children, and Infant

The purpose of this study is to learn about the safety of the 20-valent pneumococcal conjugate vaccine (20vPnC) among adults, children, and infants, as well as the immunogenicity of 20vPnC among infants and children under 2 years of age in China. This vaccine will be given as per the age-specific dosing schedules among healthy adults, children and infants in China.

This study is seeking health…

NCT07284654 — Safety, Tolerability, and Immunogenicity of VAX-31 in Adults ≥50 Years With Immunobridging to Adults 18-49

The primary objectives of this study are to evaluate the safety, tolerability, immunologic noninferiority (for shared serotypes) and immunologic superiority (for novel serotypes) of VAX-31 compared to PCV21 and PCV20 in adults ≥50 years of age, and to bridge the immune responses induced by VAX-31 in adults 50-64 years of age to adults 18-49 years of age.

NCT07365826 — A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age

This is a Phase 3, randomized, double-blind study to evaluate the safety and immunogenicity of VAX-31 and seasonal influenza vaccine in pneumococcal-naïve adults ≥ 50 years when the two vaccines are administered at the same visit or separately.

NCT07251465 — A Study to Learn How Effective is PCV20 to Help Stop Adults Who Have a Higher Chance of Getting Pneumonia

The purpose of this study is to learn how effective is PCV20 to help stop adults from getting pneumonia. Pneumonia is an infection of the lungs that can be caused by germs like bacteria, virus, or fungi. This study uses existing healthcare information. No participants will be actively enrolled. The information of participants will be taken from Kaiser Permanente Southern California’s (KPSC) ele…

NCT07425392 — Safety, Tolerability, and Immunogenicity of VAX-31 in Adults ≥50 Years With Prior Pneumococcal Vaccination

The study will evaluate the safety, tolerability, and immunogenicity of VAX-31 in adults ≥50 years of age.

NCT07428759 — Trial to Evaluate Safety and Immune Response of an Investigational Pneumococcal Vaccine in Adults Aged 50 To 64 Years

This study will evaluate the safety and immune response of a new formulation of pneumococcal vaccine, PnMAPS30plus, in healthy adults aged 50 to 64 years. Participants will receive a single dose of either the investigational vaccine or an approved pneumococcal vaccine (PCV20) and will be monitored for approximately six months. The study aims to determine if PnMAPS30plus is safe and well-tolerat…

Not Yet Recruiting

NCT07591181 — A Study on the Immunization Schedule for the 13-Valent Pneumococcal Polysaccharide-Conjugate Vaccine in Healthy Infants

To compare the immunogenicity of the domestically produced PCV13 vaccine in healthy 2-month-old infants following administration via the 2+1 and 3+1 schedules, with the primary endpoint being the seroprevalence of specific IgG antibodies after completion of the vaccination series.To evaluate the safety of the 2+1 schedule in infants and young children (incidence of adverse events and serious ad…

NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months of Age Receiving a Single Booster Dose

The main purpose of this study is to assess the safety and reactogenicity of a single dose of the new pneumococcal vaccine (called Pn-MAPS30plus) in toddlers who have previously completed a two-dose primary vaccination series with PCV used in local immunization program. PCV20 will be used as a comparator for this study.

NCT07600983 — Clinical Trial of the 24-valent Pneumococcal Polysaccharide Conjugate Vaccine (CRM197/Tetanus Toxoid)

This clinical trial consists of Phase I and Phase II. The objective is to evaluate the safety and immunogenicity of the 24-valent pneumococcal polysaccharide conjugate vaccine (CRM197/tetanus toxoid) in individuals aged 2 months (minimum 6 weeks) and older.

NCT07640841 — Health Economic Evaluation of Influenza and Pneumococcal Vaccination in COPD Patients

This is a multicenter, open-label, blank-controlled clinical trial to evaluate the impact of influenza vaccination and pneumococcal vaccination on disease progression and medical burden in COPD patients aged 45-80 years, as well as the safety and immunogenicity of vaccination. COPD patients aged 45-80 years are recruited. On the basis of informed consent and voluntary participation, influenza a…

NCT07648641 — A Clinical Trial of the 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (CRM197/Tetanus Toxoid)

This clinical study will enroll 100 participants from the 2-month-old (minimum 6 weeks) group who previously participated in the Phase III clinical trial of the 13-valent pneumococcal polysaccharide conjugate vaccine (CRM197, TT vector) (Protocol No.: CS-CTP-PCV), with 50 participants in each of the treatment and control groups, and who have completed blood sample collection for the 1-year and …

NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose Primary Dosing Series Followed by a Booster Dose at 12 to 15 Months of Age

The main purpose of this study is to evaluate safety and reactogenicity of the investigational pneumococcal vaccine (called Pn-MAPS30plus). PCV20 will be used as a comparator for this study

NCT07659470 — RANDOMIZED CONTROLLED TRIAL OF TEXT MESSAGE TO INCREASE PNEUMOCOCCAL VACCINATION IN ADULTS IN CHILE.

The goal of this randomized controlled trial is to learn if text message reminders sent through WhatsApp increase pneumococcal vaccination coverage in adults turning 65 years old in Chile. The main questions it aims to answer are:

Do text message reminders increase the proportion of adults aged 65 years who receive the pneumococcal vaccine compared to usual care? Do text message reminders incr…

NCT07639008 — Epidemiology of Invasive Bacterial Infections in Children With Sickle Cell Disease in France Between 2020 and 2025

Children with sickle cell disease are at high risk of invasive bacterial infections, which may lead to serious complications. Preventive measures, including antibiotic prophylaxis and vaccination, have changed the epidemiology of these infections over time. New pneumococcal conjugate vaccines have recently become available, and updated data are needed to better understand which bacteria are cur…

Completed Trials

NCT00148824 — Antibody Responses to Pneumococcal Vaccines Among HIV-infected Adults.

Streptococcus pneumoniae is the major cause of bacterial infection in HIV-infected patients. The current pneumococcal vaccine is poorly efficacious in patients with a CD4 cell count lower than 500/mm3. This study will test the efficacy and safety of a new pneumococcal vaccine strategy in patients with a CD4 cell count between 200 and 500/mm3.

NCT01692886 — A Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) In Healthy Infants In China

This study is primarily designed to evaluate the IgG immune responses to the 13 pneumococcal serotypes induced by 13vPnC compared with the immune responses induced by 7vPnC when measured 1 month after the infant series, and to evaluate the acceptability of the safety profile of 13vPnC as measured by the incidence rates of local reactions, systemic events and adverse events.

NCT03983616 — Surveillance of Invasive Pneumococcal Infections in Adults (Excluding Meningitis)

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 thes…

NCT02972281 — Systematic Search for Primary Immunodeficiency in Adults With Infections

Antibody deficiencies and complement deficiencies are the most frequent Primary immunodeficiencies (PIDs) in adults, and are associated with greatly increased susceptibility to recurrent and/or severe bacterial infections - especially upper and lower respiratory tract infections and meningitis. The literature data suggest that PIDs are under-diagnosed in adults. The current European and US guid…

NCT03621670 — Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants

The purpose of this study is to evaluate the safety and immunogenicity of Bexsero (meningococcal group B vaccine-rMenB+OMV NZ) in North American infants 6 weeks through 12 weeks of age, when administered concomitantly with Pneumococcal conjugate vaccine (PCV 13) and other recommended routine infant vaccinesv(RIV).

NCT03873727 — Revaccination With PPS23 Boosted or Not by PCV13 in Splenectomised Patients.

This research is a multi-center French randomized and double blind phase IIb clinical trial evaluating 2 revaccination strategies against pneumococcal infections among splenectomised patients. The main objective is to evaluate at M13 the immunological response of 2 pneumococcal revaccination strategies (combined revaccination by a boost dose of PCV13 following 12 months later by PPS23, versus P…

NCT04214444 — Evaluation of Prime-boost Anti-pneumococcal Vaccination in Patients With Diffuse Large B Cell Lymphoma Treated With Rituximab

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-cel…

NCT04939350 — Evaluation of the Vaccination Coverage of Cirrhotic Patients Followed in the General Hospitals in France in 2021

the purpose of this study is to estimate vacinal coverage against hepatitis A and B viruses, pneumococcus, diphtheria/tetanos and poliomyelitis, influenza virus and covid in cirrhotic patients followed in general hospitals of France and to show the

NCT05393037 — Safety and Immunogenicity of V116 in Adults Living With Human Immunodeficiency Virus (HIV) (V116-007, STRIDE-7)

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.

NCT05535868 — Experimental Human Pneumococcal Challenge With SPN3

The ‘Experimental Human Pneumococcal challenge’ (EHPC) model is a way of putting drops of bacteria into the nose. Investigators have studied this model of putting bacteria in the nose safely in over 1500 volunteers over the past decade with no serious side effects and now want to test the model using a different strain of the bacteria that is commonly found in the community, SPN3.

The aim of t…

NCT05569954 — Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults 50 Years of Age or Older (V116-010, STRIDE-10)

This is a phase 3, randomized, double-blind, active comparator-controlled study of the safety, tolerability, and immunogenicity of V116 in pneumococcal vaccine-naïve adults 50 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 immunogenici…

NCT05696080 — Safety and Immunogenicity of V116 in Adults With Increased Risk for Pneumococcal Disease (V116-008)

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 adul…

NCT06182124 — A Study to Learn About the Safety and Immune Response of a New Pneumococcal Vaccine in Adults

The purpose of this study is to learn about the safety and immune effects of a pneumococcal vaccine in adults. This vaccine can possibly provide protection against further pneumococcal disease.

This study will happen in 4 stages: Stage 1 is seeking participants who are between 18 years to 49 years of age. The participants will receive 1 of 2 pneumococcal vaccine candidates (different formulati…

NCT06177912 — A Clinical Study of the V116 Vaccine for Children and Teenagers (V116-013)

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V116 compared to PPSV23 in children and teenagers 2 through 17 years of age, who had completed routine pneumococcal vaccine as infants/toddlers. Researchers want to learn if V116 is as good as, or is better than the PPSV23 vaccine in terms of the antibody immune response. V116 and PPSV23 will be studied in …

NCT06531538 — A Study to Learn About How a New Pneumococcal Vaccine Works in Children

The purpose of this study is to learn about the safety, tolerability and immune effects of a pneumococcal vaccine in toddlers.

Participants will take part in this study for approximately 6 or 8 months depending on which group they are assigned to. During this time participants will have 2 clinic visits and 1 phone visit for the 1-Dose group, or 3 clinic visits and 1 phone visit for the 2-Dose …

NCT06638333 — Prevalence and Serotype Distribution of Streptococcus Pneumoniae in Healthy Vietnamese Children From 6 Months to 5 Years Old

This observational study is designed as a cross-sectional survey of children from 6 months and 5 years old who visit the Vietnam Vaccination Center (VNVC) system in Hanoi, Danang and Ho Chi Minh City for vaccination services.

After getting the informed consent form from a parent/guardian for their child(s) to participate in the study, nasopharyngeal swab sample will be taken. His/her guardian …

NCT07322549 — Amoxicillin/Clavulanic Acid Susceptibility in Acute Community-acquired Pneumonia Requiring Intensive Care Management

Severe community-acquired pneumonia (CAP) and community-acquired aspiration pneumonia (CAAP) are common reasons for adult emergency department visits and subsequent admission to the intensive care unit (ICU). Three bacteria are primarily implicated in this type of pneumonia: Streptococcus pneumoniae, Haemophilus influenzae, and Staphylococcus aureus.

Empirical antibiotic therapy for this condi…

NCT07543198 — Clinical Trial of PCV24 in Adults Aged ≥18 Years

A Phase Ib/II clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24)developed by Sinovac Life Science Co., Ltd will be conducted in adults aged ≥18 years.

The objective of the study is to evaluate the safety and immunogenicity of Sinovac PCV24. The trial is a randomized, double-blind, Positive Controlled phase Ib/II clinical trial.

NCT07019909 — A Study to Learn About How Safe and Effective is 20vPnC and 13vPnC Vaccines in Chinese Adults

This Phase 1, randomized, double-blind, third-party-unblinded study will be conducted at investigational sites in China. The purpose of the study is to learn about the safety and immune response of 20vPnC and 13vPnC in Chinese adults 50 years of age and older who did not receive any of pneumococcal vaccine in the past

NCT07105722 — A Trial to Evaluate the Safety and Immune Response of an Investigational Pneumococcal Vaccine in Adults 50 To 64 Years of Age

This clinical study is designed to evaluate an investigational pneumococcal vaccine named Pn-MAPS30plus. The vaccine is designed to stimulate the immune system to produce antibodies against various serotypes of the S. pneumoniae bacteria, potentially aiding the body in fighting infection upon exposure. Pn-MAPS30plus aims to broaden protection by covering more serotypes than currently licensed p…