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- ||||||| Capvaxive (V116) / Merck (MSD)
Trial completion: Safety and Immunogenicity of V116 in Pneumococcal Vaccine-na (clinicaltrials.gov) - Mar 4, 2025
P3, N=1484, Completed, Sponsor: Merck Sharp & Dohme LLC
Active, not recruiting --> Completed
- | Capvaxive (V116) / Merck (MSD), Pneumovax 23 (23-valent pneumococcal polysaccharide) / Merck (MSD)
Biomarker, Clinical, Review, Journal: Establishing a new human pneumococcal standard reference serum, MPRSS-01. (Pubmed Central) - Jan 28, 2025
With the development of next-generation PCVs, a new S. pneumoniae reference serum standard was needed to include serotypes beyond the existing 24 in 007sp. In this study, antibody concentrations to 33 pneumococcal serotypes were assigned in a new Merck Pneumococcal Reference Serum Standard (MPRSS-01) using the pneumococcal electrochemiluminescence assay, enabling V116 to maintain the link to the historical human pneumococcal standard reference serum while utilizing the new human pneumococcal reference serum.
- | Journal: Expanded Recommendations for Use of Pneumococcal Conjugate Vaccines Among Adults Aged ?50 Years: Recommendations of the Advisory Committee on Immunization Practices - United States, 2024. (Pubmed Central) - Jan 12, 2025
Options included either 20-valent PCV (PCV20; Prevnar20; Wyeth Pharmaceuticals) or 21-valent PCV (PCV21; CAPVAXIVE; Merck Sharp & Dohme) alone or 15-valent PCV (PCV15; VAXNEUVANCE; Merck Sharp & Dohme) in series with 23-valent pneumococcal polysaccharide vaccine (PPSV23; Pneumovax23; Merck Sharp & Dohme)...Recommendations for PCVs among adults aged 19-49 years with risk conditions and PCV13-vaccinated adults have not changed from previous recommendations. This report summarizes evidence considered for these recommendations and provides updated clinical guidance for use of PCV.
- | Capvaxive (V116) / Merck (MSD)
Journal, HEOR: Health and economic impact of the 21-Valent pneumococcal conjugate vaccine (V116) for adults in Japan: A delta price approach. (Pubmed Central) - Jan 3, 2025
This report summarizes evidence considered for these recommendations and provides updated clinical guidance for use of PCV. V116 was found to be cost-saving at price premiums up to
- ||| Capvaxive (V116) / Merck (MSD), Pneumovax 23 (23-valent pneumococcal polysaccharide) / Merck (MSD), Vaxneuvance (15-valent pneumococcal conjugate vaccine) / Merck (MSD)
P3 data, Journal, Pneumococcal vaccines: 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 (Stride-6). (Pubmed Central) - Dec 17, 2024
P3
V116 was found to be cost-saving at price premiums up to V116 is well tolerated with a safety profile comparable to currently licensed pneumococcal vaccines and generates IgG and functional immune responses to all V116 serotypes, regardless of prior pneumococcal vaccine received.
- | Capvaxive (V116) / Merck (MSD), Vaxneuvance (15-valent pneumococcal conjugate vaccine) / Merck (MSD)
Journal, HEOR, Cost-effectiveness, Cost effectiveness: Cost-Effectiveness Analysis of the Use of V116, a 21-Valent Pneumococcal Conjugate Vaccine, in Vaccine-Na (Pubmed Central) - Nov 15, 2024
V116 is well tolerated with a safety profile comparable to currently licensed pneumococcal vaccines and generates IgG and functional immune responses to all V116 serotypes, regardless of prior pneumococcal vaccine received. These results demonstrated that using V116 in adults aged???65
- Capvaxive (V116) / Merck (MSD)
Evaluating the Potential Health and Economic Impact of V116, an Adult Specific 21-Valent Pneumococcal Conjugate Vaccine, on Invasive Pneumococcal Disease in Germany () - Nov 4, 2024 - Abstract #ISPOREU2024ISPOR_EU_3037;
These results demonstrated that using V116 in adults aged???65 V116 led to a greater reduction (compared to PCV20) of both the health and economic burden associated with IPD among adults aged 50+years in Germany
- Capvaxive (V116) / Merck (MSD)
Estimating the Potential Lifetime Health and Economic Impact of V116 on Pneumococcal Disease in Brazil () - Nov 4, 2024 - Abstract #ISPOREU2024ISPOR_EU_2804;
V116 led to a greater reduction (compared to PCV20) of both the health and economic burden associated with IPD among adults aged 50+years in Germany Comparing with PCV20, V116 led to a greater reduction of both the health and economic burden associated with pneumococcal disease in Brazil 60+ population.
- Capvaxive (V116) / Merck (MSD)
Predicting the Public Health Impact of Different Adult Pneumococcal Vaccines in Japan Using a Dynamic Transmission Model () - Nov 4, 2024 - Abstract #ISPOREU2024ISPOR_EU_2799;
Comparing with PCV20, V116 led to a greater reduction of both the health and economic burden associated with pneumococcal disease in Brazil 60+ population. The model predicted that V116 in 65+ year-olds led to greater reductions in IPD than PPSV23 and PCV20, underscoring that V116 offers greater protection against IPD to older adults than other vaccines.
- Capvaxive (V116) / Merck (MSD)
Estimating the Potential Lifetime Health and Economic Impact of V116 on Pneumococcal Disease in Mexico () - Nov 4, 2024 - Abstract #ISPOREU2024ISPOR_EU_2593;
The model predicted that V116 in 65+ year-olds led to greater reductions in IPD than PPSV23 and PCV20, underscoring that V116 offers greater protection against IPD to older adults than other vaccines. Compared to PCV13, V116 demonstrated more than twice the reduction averted by PCV20 in both the health and economic burden of pneumococcal disease in older adults in Mexico.
- Capvaxive (V116) / Merck (MSD)
Evaluating the Potential Health and Economic Impact of V116, an Adult Specific 21-Valent Pneumococcal Conjugate Vaccine, on Invasive Pneumococcal Disease in Spain () - Nov 4, 2024 - Abstract #ISPOREU2024ISPOR_EU_2313;
Compared to PCV13, V116 demonstrated more than twice the reduction averted by PCV20 in both the health and economic burden of pneumococcal disease in older adults in Mexico. In both age groups, V116 resulted in a greater reduction of both the health and economic burden associated with IPD, as compared to PCV20.
- Capvaxive (V116) / Merck (MSD)
Estimating the Potential Lifetime Health and Economic Impact of V116, an Adult Specific 21-Valent Pneumococcal Conjugate Vaccine, on Invasive Pneumococcal Disease in the Netherlands () - Nov 4, 2024 - Abstract #ISPOREU2024ISPOR_EU_2232;
In both age groups, V116 resulted in a greater reduction of both the health and economic burden associated with IPD, as compared to PCV20. In both age groups, comparing with PCV20, V116 led to a greater reduction of both the health and economic burden associated with IPD in the Netherlands.
- Capvaxive (V116) / Merck (MSD)
Estimating the Potential Lifetime Health and Economic Impact of V116, an Adult Specific 21-Valent Pneumococcal Conjugate Vaccine, on Invasive Pneumococcal Disease in Greece () - Nov 4, 2024 - Abstract #ISPOREU2024ISPOR_EU_227;
In both age groups, comparing with PCV20, V116 led to a greater reduction of both the health and economic burden associated with IPD in the Netherlands. In both age groups, comparing with PCV20, V116 led to a greater reduction of both the health and economic burden associated with IPD in Greece.
- Capvaxive (V116) / Merck (MSD)
Evaluating the Potential Health and Economic Impact of V116, an Adult Specific 21-Valent Pneumococcal Conjugate Vaccine, on Invasive Pneumococcal Disease in Switzerland () - Nov 4, 2024 - Abstract #ISPOREU2024ISPOR_EU_90;
In both age groups, comparing with PCV20, V116 led to a greater reduction of both the health and economic burden associated with IPD in Greece. V116 led to a greater reduction (compared to PCV20) of both the health and economic burden associated with IPD among adults aged 50+ years in Switzerland.
- | Vaxneuvance (15-valent pneumococcal conjugate vaccine) / Merck (MSD)
Journal: Prevalence, Clinical Severity, and Serotype Distribution of Pneumococcal Pneumonia Among Adults Hospitalized With Community-Acquired Pneumonia in Tennessee and Georgia, 2018-2022. (Pubmed Central) - Oct 15, 2024
Approximately 12% of adults hospitalized with CAP had S. pneumoniae detected, and approximately one-third of the detected pneumococcal serotypes were not contained in PCV15 or PCV20. Development of new pneumococcal vaccines with expanded serotype coverage has the potential to prevent a substantial burden of disease.
- Capvaxive (V116) / Merck (MSD), Vaxneuvance (15-valent pneumococcal conjugate vaccine) / Merck (MSD)
A phase III randomized study to evaluate the safety, tolerability and immunogenicity of V116, an adult-specific pneumococcal conjugate vaccine (PCV), followed by PCV15, in adults living with HIV (STRIDE-7) () - Oct 15, 2024 - Abstract #HIVGlasgow2024HIV_Glasgow_105;
P3
Development of new pneumococcal vaccines with expanded serotype coverage has the potential to prevent a substantial burden of disease. In adults living with HIV, V116 was well tolerated and induced comparable immune responses to PCV15 + PPSV23 for common serotypes and higher responses for V116-unique serotypes.
- | Capvaxive (V116) / Merck (MSD), Vaxneuvance (15-valent pneumococcal conjugate vaccine) / Merck (MSD)
Journal: Capvaxive - A 21-valent pneumococcal conjugate vaccine. (Pubmed Central) - Oct 9, 2024
In adults living with HIV, V116 was well tolerated and induced comparable immune responses to PCV15 + PPSV23 for common serotypes and higher responses for V116-unique serotypes. No abstract available
- ||||| Capvaxive (V116) / Merck (MSD)
Enrollment closed: STRIDE-13: A Clinical Study of the V116 Vaccine for Children and Teenagers (V116-013) (clinicaltrials.gov) - Sep 19, 2024
P3, N=820, Active, not recruiting, Sponsor: Merck Sharp & Dohme LLC
No abstract available Recruiting --> Active, not recruiting
- ||| Vaxneuvance (15-valent pneumococcal conjugate vaccine) / Merck (MSD)
Clinical guideline, Journal: Use of 21-Valent Pneumococcal Conjugate Vaccine Among U.S. Adults: Recommendations of the Advisory Committee on Immunization Practices - United States, 2024. (Pubmed Central) - Sep 12, 2024
Previously, options included either 20-valent PCV (PCV20; Prevnar20; Wyeth Pharmaceuticals, Inc.) alone or a 15-valent PCV (PCV15; VAXNEUVANCE; Merck Sharp & Dohme, LLC) in series with 23-valent pneumococcal polysaccharide vaccine (PPSV23; Pneumovax23; Merck Sharp & Dohme, LLC)...Indications for PCV have not changed from previous recommendations. This report summarizes evidence considered for these recommendations and provides clinical guidance for use of PCV21.
- Capvaxive (V116) / Merck (MSD)
Cost-Effectiveness of V116, an Adult Specific 21-Valent Pneumococcal Conjugate Vaccine, vs. PCV20 on Pneumococcal Disease in Japan--A Delta-Price Approach (Halls JK) - Sep 4, 2024 - Abstract #IDWeek2024IDWEEK_2950;
- Quantifying the impact of introducing a new adult-focused PCV in the United States (Halls JK) - Sep 4, 2024 - Abstract #IDWeek2024IDWEEK_1056;
- Assessing the Epidemiological Impact of an Age-Based Pneumococcal Vaccine Recommendation in France (Halls JK) - Sep 4, 2024 - Abstract #IDWeek2024IDWEEK_1045;
- Evaluating the Epidemiological Impact of Lowering the Recommended Age for Adult Pneumococcal Vaccination in the United States (Halls JK) - Sep 4, 2024 - Abstract #IDWeek2024IDWEEK_1044;
- Modeling the Epidemiological Impact of Different Adult Vaccination Strategies in the United Kingdom (Halls JK) - Sep 4, 2024 - Abstract #IDWeek2024IDWEEK_1024;
- Capvaxive (V116) / Merck (MSD)
A Phase 3, Randomized Trial Investigating the Safety, Tolerability, and Immunogenicity of V116, an Investigational Adult-Specific Pneumococcal Conjugate Vaccine, in Pneumococcal Vaccine-Na (Halls JK) - Sep 4, 2024 - Abstract #IDWeek2024IDWEEK_1017;
- | pneumococcal vaccine (V116) / Merck (MSD)
Journal, HEOR: Lifetime Health and Economic Burden of Invasive Pneumococcal Diseases Attributable to V116 Serotypes Among Adults in the United States. (Pubmed Central) - May 26, 2024
These results show that V116 serotypes (compared to PCV20) are associated with substantially higher clinical and economic burden of IPD. The addition of V116 to vaccination recommendations can help to reduce the residual burden of IPD in US adults.
- pneumococcal vaccine (V116) / Merck (MSD)
Evaluating the Potential Health and Economic Impact of V116, an Adult Specific 21-Valent Pneumococcal Conjugate Vaccine, on Invasive Pneumococcal Disease in the United States () - Mar 8, 2024 - Abstract #ISPOR2024ISPOR_864;
The addition of V116 to vaccination recommendations can help to reduce the residual burden of IPD in US adults. In both age groups, comparing with PCV20, V116 led to a greater reduction of both the health and economic burden associated with IPD.
- ||||||| Capvaxive (V116) / Merck (MSD), Vaxneuvance (15-valent pneumococcal conjugate vaccine) / Merck (MSD)
Trial completion: STRIDE-8: Safety and Immunogenicity of V116 in Adults With Increased Risk for Pneumococcal Disease (V116-008) (clinicaltrials.gov) - Feb 28, 2024
P3, N=518, Completed, Sponsor: Merck Sharp & Dohme LLC
In both age groups, comparing with PCV20, V116 led to a greater reduction of both the health and economic burden associated with IPD. Active, not recruiting --> Completed
- pneumococcal vaccine (V116) / Merck (MSD), Vaxneuvance (15-valent pneumococcal conjugate vaccine) / Merck (MSD)
IMMUNOGENICITY OF V116 (21-VALENT PCV) IN ADULTS ?50 YEARS OF AGE BY TIME SINCE PRIOR PNEUMOCOCCAL VACCINATION: SUBGROUP ANALYSIS OF A PHASE 3 TRIAL (STRIDE-6) (Poster Area; Board 302) - Feb 24, 2024 - Abstract #ISPPD2024ISPPD_694;
P3
In pneumococcal vaccine-experienced adults, V116 elicits immune responses for all 21 serotypes, regardless of time since prior pneumococcal vaccination. These findings support V116 as a novel population-specific vaccine for the prevention of PD in adults.
- pneumococcal vaccine (V116) / Merck (MSD)
A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF V116 ADMINISTERED CONCOMITANTLY WITH INFLUENZA VACCINE IN ADULTS ?50 YEARS (STRIDE-5) (Poster Area; Board 330) - Feb 24, 2024 - Abstract #ISPPD2024ISPPD_602;
In healthy adults, V116 is well tolerated and immunogenic when given concomitantly with QIV. Study results support use of V116 with QIV in adults ?50 years of age.
- pneumococcal vaccine (V116) / Merck (MSD)
ESTIMATES OF THE HEALTH AND ECONOMIC BURDEN OF PNEUMOCOCCAL DISEASES ATTRIBUTABLE TO V116 VS PCV20 SEROTYPES AMONG ADULTS IN FINLAND (Poster Area; Board 402) - Feb 24, 2024 - Abstract #ISPPD2024ISPPD_567;
V116 serotypes accounted for 16.5% more IPD/NBPP cases and deaths. Based on these results, V116 may help to reduce the health and economic burden associated with pneumococcal disease among older adults in Finland.
- Vaxneuvance (15-valent pneumococcal conjugate vaccine) / Merck (MSD)
NO IMPACT OF INTRINSIC KILLING POSITIVE SAMPLES ON PNEUMOCOCCAL PCV FUNCTIONAL ANTIBODY TITER RESULT IN HEALTHY POPULATIONS (Poster Area; Board 318) - Feb 24, 2024 - Abstract #ISPPD2024ISPPD_543;
A total of 20201 clinical samples from Merck's 15- and 21-valent PCVs, V114 and V116, were tested in IK assays (group 1: healthy children, n=3250; group 2: healthy adults, n=16951). The use of IK screening as a prerequisite to MOPA testing has limited benefit.
- pneumococcal vaccine (V116) / Merck (MSD)
A PHASE 3 RANDOMIZED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF V116 (A 21-VALENT PCV) IN ADULTS LIVING WITH HIV (STRIDE7: PART A) (Poster Area; Board 313) - Feb 24, 2024 - Abstract #ISPPD2024ISPPD_524;
P3
The use of IK screening as a prerequisite to MOPA testing has limited benefit. In adults living with HIV, V116 was well tolerated and induced comparable immune responses to PCV15 + PPSV23 for common serotypes and higher responses for V116-unique serotypes.
- pneumococcal vaccine (V116) / Merck (MSD)
PNEUMOCOCCAL SEROTYPE DISTRIBUTION IN ADULTS 65 YEARS AND OLDER AROUND THE WORLD, 2013-2023 (Virtual) - Feb 24, 2024 - Abstract #ISPPD2024ISPPD_464;
Even after pediatric PCV adoption in various countries, the burden of PD in adults remains high. V116, an investigational PCV specific to adults, has the potential to prevent more adult PD than other licensed adult PCVs, including PCV20.
- pneumococcal vaccine (V116) / Merck (MSD)
IMMUNOGENICITY OF V116 (21-VALENT PCV) IN PNEUMOCOCCAL-NA (Poster Area; Board 309) - Feb 24, 2024 - Abstract #ISPPD2024ISPPD_438;
P3
V116 was immunogenic for all 21 vaccine serotypes across all age subgroups, with responses higher than PCV20 for serotypes unique to V116. These findings support V116 as a novel population-specific vaccine for the prevention of PD in older adults.
- pneumococcal vaccine (V116) / Merck (MSD)
PHASE 3 RANDOMIZED STUDY TO EVALUATE LOT-TO-LOT CONSISTENCY, SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF V116 (A 21-VALENT PCV) IN ADULTS 18 (Poster Area; Board 315) - Feb 24, 2024 - Abstract #ISPPD2024ISPPD_352;
V116 is comparable to PPSV23 for common serotypes and higher for serotypes unique to V116, and is generally well tolerated, with a safety profile comparable to PPSV23. These data support the use of V116 in adults.
- pneumococcal vaccine (V116) / Merck (MSD)
ANTICIPATED IMPACT OF NEW ADULT-SPECIFIC PNEUMOCOCCAL VACCINE IN LATE DEVELOPMENT (Poster Area; Board 391) - Feb 24, 2024 - Abstract #ISPPD2024ISPPD_326;
Based on IPD surveillance data from key countries, serotype coverage by V116 was ~16-32% higher than that by PCV20 among adults 65+ years in 2019. V116 includes serotypes responsible for the majority of IPD and is expected to prevent more IPD cases than PCV20 among 65+.
- pneumococcal vaccine (V116) / Merck (MSD)
A PHASE 3 STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF V116 IN PNEUMOCOCCAL VACCINE-NA (Poster Area; Board 326) - Feb 24, 2024 - Abstract #ISPPD2024ISPPD_284;
V116 elicits immune responses that are noninferior to PPSV23 for the common serotypes and 15B, superior to PPSV23 for the unique serotypes in V116 and has a safety profile comparable to PPSV23. V116, specifically designed for adults, is expected to protect against the majority of serotypes responsible for pneumococcal disease.
- |||||| Capvaxive (V116) / Merck (MSD)
Enrollment open: STRIDE-13: A Clinical Study of the V116 Vaccine for Children and Teenagers (V116-013) (clinicaltrials.gov) - Jan 25, 2024
P3, N=820, Recruiting, Sponsor: Merck Sharp & Dohme LLC
V116, specifically designed for adults, is expected to protect against the majority of serotypes responsible for pneumococcal disease. Not yet recruiting --> Recruiting
- ||||||| Capvaxive (V116) / Merck (MSD)
Trial completion: Safety and Immunogenicity of V116 in Adults Living With Human Immunodeficiency Virus (HIV) (V116-007, STRIDE-7) (clinicaltrials.gov) - Jan 25, 2024
P3, N=313, Completed, Sponsor: Merck Sharp & Dohme LLC
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- pneumococcal vaccine (V116) / Merck (MSD), Vaxneuvance (15-valent pneumococcal conjugate vaccine) / Merck (MSD)
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 (STRIDE-6) (Station 02; Board 009) - Jan 4, 2024 - Abstract #ISPPD2024ISPPD_150;
Active, not recruiting --> Completed V116 is well tolerated with a safety profile comparable to currently licensed pneumococcal vaccines, and generates functional immune responses to all V116 serotypes, regardless of prior pneumococcal vaccine received.
- Vaxneuvance (15-valent pneumococcal conjugate vaccine) / Merck (MSD)
PNEUMOCOCCAL SEROTYPE DISTRIBUTION AMONG OLDER ADULTS HOSPITALIZED WITH COMMUNITY-ACQUIRED PNEUMONIA IN THE UNITED STATES, 2018-2022 (Meeting Room 1.40) - Jan 4, 2024 - Abstract #ISPPD2024ISPPD_99;
Among the 267 serotype detections, 145 (54.3%) were within PCV15 coverage, 170 (63.7%) were within PCV20 coverage, and 225 (84.3%) were within V116 coverage; 97 (36.3%) of the detected serotypes were contained within V116 coverage only and not PCV15 or PCV20 (Table). Conclusions Based on testing for 30 pneumococcal serotypes with novel SSUAD assays, more than 10% of adults ?50 years old hospitalized with community-acquired pneumonia had pneumococcal etiology and over one-third of these patients had pneumococcal serotypes not contained within currently licensed pneumococcal conjugate vaccines.
- |||||||||| Capvaxive (V116) / Merck (MSD)
New P3 trial: STRIDE-13: A Clinical Study of the V116 Vaccine for Children and Teenagers (V116-013) (clinicaltrials.gov) - Dec 20, 2023
P3, N=820, Not yet recruiting, Sponsor: Merck Sharp & Dohme LLC
- ||||| Capvaxive (V116) / Merck (MSD), Vaxneuvance (15-valent pneumococcal conjugate vaccine) / Merck (MSD)
Enrollment closed: STRIDE-8: Safety and Immunogenicity of V116 in Adults With Increased Risk for Pneumococcal Disease (V116-008) (clinicaltrials.gov) - Aug 24, 2023
P3, N=500, Active, not recruiting, Sponsor: Merck Sharp & Dohme LLC
Conclusions Based on testing for 30 pneumococcal serotypes with novel SSUAD assays, more than 10% of adults ?50 years old hospitalized with community-acquired pneumonia had pneumococcal etiology and over one-third of these patients had pneumococcal serotypes not contained within currently licensed pneumococcal conjugate vaccines. Recruiting --> Active, not recruiting
- || pneumococcal vaccine (V116) / Merck (MSD)
P1 data, Journal: Safety, tolerability, and immunogenicity of a 21-valent pneumococcal conjugate vaccine, V116, in Japanese healthy adults: A Phase I study. (Pubmed Central) - Jul 4, 2023
The OPA and IgG findings showed that the immunogenicity of V116 and PPSV23 were comparable for the 12 common serotypes and V116 was more immunogenic for the nine unique serotypes compared with PPSV23. V116 was well tolerated, with a safety profile similar to PPSV23, and induced functional antibodies against all 21 serotypes.
- ||||||| Capvaxive (V116) / Merck (MSD)
Trial completion: 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) (clinicaltrials.gov) - Jun 27, 2023
P3, N=1080, Completed, Sponsor: Merck Sharp & Dohme LLC
V116 was well tolerated, with a safety profile similar to PPSV23, and induced functional antibodies against all 21 serotypes. Active, not recruiting --> Completed
- ||||||| Capvaxive (V116) / Merck (MSD)
Trial completion: 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) (clinicaltrials.gov) - Jun 12, 2023
P3, N=2157, Completed, Sponsor: Merck Sharp & Dohme LLC
Active, not recruiting --> Completed Active, not recruiting --> Completed
- ||||||| Capvaxive (V116) / Merck (MSD)
Trial completion, Pneumococcal vaccines: Safety and Immunogenicity of V116 in Pneumococcal Vaccine-na (clinicaltrials.gov) - Jun 5, 2023
P3, N=2664, Completed, Sponsor: Merck Sharp & Dohme LLC
Active, not recruiting --> Completed Active, not recruiting --> Completed
- ||||||| Capvaxive (V116) / Merck (MSD)
Trial completion, Pneumococcal vaccines: Safety and Immunogenicity of V116 in Vaccine-na (clinicaltrials.gov) - May 31, 2023
P3, N=450, Completed, Sponsor: Merck Sharp & Dohme LLC
Active, not recruiting --> Completed Active, not recruiting --> Completed
- ||||||| Capvaxive (V116) / Merck (MSD), Vaxneuvance (15-valent pneumococcal conjugate vaccine) / Merck (MSD)
Trial completion, Pneumococcal vaccines: A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-experienced Adults (V116-006, STRIDE-6) (clinicaltrials.gov) - May 23, 2023
P3, N=717, Completed, Sponsor: Merck Sharp & Dohme LLC
Active, not recruiting --> Completed Active, not recruiting --> Completed