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Pneumococcal Vaccines clinical trials

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NCT ID: NCT05540028 Completed - Clinical trials for Pneumococcal Vaccines

Study to Evaluate a 25-Valent Pneumococcal Conjugate Vaccine

IVT PCV-25
Start date: September 28, 2022
Phase: Phase 1
Study type: Interventional

A first-in-human, Phase 1 trial to evaluate safety, tolerability, and immunogenicity of Inventprise's (IVT) 25-valent pneumococcal conjugate vaccine (IVT PCV-25)

NCT ID: NCT05297578 Completed - Clinical trials for Pneumococcal Vaccines

Safety, Tolerability, and Immunogenicity Study of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Older Adults

Start date: June 15, 2022
Phase: Phase 2
Study type: Interventional

The objective of the study is to evaluate the safety and tolerability of a single injection of VAX-24 at 3 dose levels compared to Prevnar 20™ (PCV20) in adults 65 years of age and older.

NCT ID: NCT05266456 Completed - Clinical trials for Pneumococcal Vaccines

Safety, Tolerability, and Immunogenicity Study of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Adults

Start date: February 22, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The objective of the study is to evaluate the safety and tolerability of a single injection of VAX-24 at 3 dose levels compared to Prevnar 20™ (PCV20) in adults 18 to 49 years of age in Phase 1. The Phase 2 will evaluate the safety, tolerability, and immunogenicity of a single injection of VAX-24 at 3 dose levels compared to PCV20 in adults aged 50 to 64 years of age in Phase 2.

NCT ID: NCT03893448 Completed - Clinical trials for Pneumococcal Infections

Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-029)

PNEU-PED
Start date: June 19, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V114 in healthy infants. The primary hypotheses are that: 1) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes between V114 and Prevnar 13™ based on response rates at 30 days following Dose 3; 2) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on the response rate of the 2 unique V114 serotypes compared with the lowest response rate of any of the shared serotypes in Prevnar 13™, excluding serotype 3, at 30 days following Dose 3; 3) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes based on anti-pneumococcal polysaccharide (PnPs) serotype-specific immunoglobulin g (IgG) geometric mean concentrations (GMCs) at 30 days following Dose 3; 4) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on the anti-PnPs serotype-specific IgG GMCs of the 2 unique V114 serotypes compared with the lowest IgG GMC of any of the shared serotypes in Prevnar 13™, excluding serotype 3, at 30 days following Dose 3; 5) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes between V114 and Prevnar 13™ based on anti-PnPs serotype-specific IgG GMCs at 30 days following Dose 4; and 6) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on anti-PnPs serotype-specific IgG GMCs of the 2 unique V114 serotypes compared with the lowest IgG GMC of any of the shared serotypes in Prevnar 13, excluding serotype 3, at 30 days following Dose 4.

NCT ID: NCT01964716 Completed - Clinical trials for Pneumococcal Vaccines

13vPnC Multidose Vial Safety, Tolerability and Immunogenicity Study in Healthy Infants.

Start date: January 2014
Phase: Phase 3
Study type: Interventional

This study will compare the immune responses of the infants who have been given 13vPnC in the mutidose vial formulation to the immune reponses of the infants who have been given 13vPnC in the single-dose syringe formulation. It will also evaluate the safety of 13-valent pneumococcal conjugate vaccine (13vPnC) in all infants who are vaccinated.

NCT ID: NCT01953510 Completed - Clinical trials for Pneumococcal Vaccines

Trial of Pneumococcal Vaccine Schedules in Ho Chi Minh City, Vietnam

Start date: September 30, 2013
Phase: Phase 2/Phase 3
Study type: Interventional

Pneumococcus is a group of bacteria that can cause pneumonia, meningitis and other diseases. These bacteria normally live in the nose of humans and are spread from person to person by touching or sneezing. There are vaccines available to protect against infection with these bacteria, and pneumococcus is currently the leading vaccine-preventable cause of death in young children. In countries where pneumococcal vaccine (PCV) has been introduced, there has been a big impact on the amount of disease caused by these bacteria. However, many countries, especially developing countries, are yet to introduce PCV as part of their routine immunizations. Currently a total of four doses of PCV is recommended, and the main barrier to vaccine introduction is cost. This study aims to identify a vaccination schedule to make PCV more effective and affordable for Vietnam and other developing countries. This study has two distinct purposes: 1) to compare different dosage schedules of PCV and 2) to compare different PCV vaccines. 1. Schedules of Synflorix (PCV10) involving a three, two or one dose PCV primary series and two booster options will be compared. Comparisons will be made firstly in terms of measures of immunity to the vaccine, and secondly in terms of the effect of vaccination on the carriage of bacteria in the nose. 2. The responses to PCV10 and Prevenar-13 (PCV13) will be compared, in the schedule most likely to be considered for global use. Again, comparisons will be made in terms of measures of immunity and effect on carriage in the nose. Infants aged two months will be randomly assigned to one of six study groups and will provide up to four blood samples for analysis of the measures of immunity and five nose swabs for analysis of carriage of bacteria. Infants will be followed up 8-9 times until the age of 24 months. An additional control group will be recruited at 18 months of age and also followed up until 24 months of age. The results of this study will be used to facilitate decision making, at global and national levels, regarding introduction of PCV.

NCT ID: NCT01646398 Completed - Clinical trials for Pneumococcal Vaccines

A Phase 3 Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Japanese Elderly Adults Aged 65 Years Old and Older

Start date: June 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability and immunogenicity of a single dose of 13-valent pneumococcal conjugate vaccine compared to a single dose of 23-valent pneumococcal polysaccharide vaccine in Japanese adults aged 65 years old and older.

NCT ID: NCT01537185 Completed - Clinical trials for Pneumococcal Vaccines

Phase I Safety Trial of Streptococcus Pneumoniae Whole Cell Vaccine (SPWCV) + Alum in Healthy Adults

Start date: February 2012
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine if a Streptococcus pneumoniae Whole Cell Vaccine (SPWCV) given with alum is safe and well tolerated by healthy adults.

NCT ID: NCT01392378 Completed - Clinical trials for Pneumococcal Vaccines

Study Assessing the Effect of Medications to Prevent Fever on Prevenar 13®

Start date: August 2011
Phase: Phase 4
Study type: Interventional

The purposes of this study are assess the immunological response (measure the amount of antibodies, i.e. proteins that fight off germs) produced by children after they have been given the 13-valent pneumococcal vaccine (13vPnC) and INFANRIX hexa at 2, 3, 4 and 12 months of age when medications to prevent fever are given on the same day as the vaccination. Also to evaluate the safety of 13-valent pneumococcal conjugate vaccine (13vPnC) in children who receive medications to prevent fever on the day of vaccination.

NCT ID: NCT00824655 Completed - Clinical trials for Pneumococcal Vaccines

Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Children

Start date: March 2009
Phase: Phase 3
Study type: Interventional

The purposes of this study are to evaluate the safety of 13-valent pneumococcal Conjugate Vaccine (13vPnC) in children who have already been vaccinated with Prevenar. The study will also assess the immunological response (measure the amount of antibodies, i.e. proteins that fight off germs) produced by children after they have been given the 13-valent pneumococcal vaccine at 5 and 12 months or 12 months of age. In addition, reactions at the injection site will be assessed during the study.