Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03547167
Other study ID # V114-017
Secondary ID 2017-004915-38V1
Status Completed
Phase Phase 3
First received
Last updated
Start date July 16, 2018
Est. completion date January 20, 2020

Study information

Verified date December 2020
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is designed to 1) describe the safety, tolerability, and immunogenicity of V114 and Prevnar 13™ in pneumococcal vaccine-naïve adults at increased risk for pneumococcal disease and to 2) describe the safety, tolerability, and immunogenicity of PNEUMOVAX™23 when administered 6 months after receipt of either V114 or Prevnar 13™. Increased risk for pneumococcal disease is defined as 1) an underlying medical condition, 2) behavioral habits such as smoking or alcohol use, or 3) living in a community/environment with increased risk of disease transmission.


Recruitment information / eligibility

Status Completed
Enrollment 1515
Est. completion date January 20, 2020
Est. primary completion date January 20, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 49 Years
Eligibility Inclusion Criteria: - Native American participant enrolled from any of the clinical sites of the Johns Hopkins Center for American Indian Health (CAIH) without any of the pre-specified risk conditions for pneumococcal disease listed below, OR Native American participant enrolled from any of the CAIH sites or participant from a site other than CAIH with =1 of the following risk conditions for pneumococcal disease: 1. Diabetes mellitus Type 1 or Type 2 and with hemoglobin A1c (HgA1c) <10% 2. Chronic liver disease with documented history of compensated cirrhosis (Child-Pugh Score A) 3. Confirmed diagnosis of Chronic Obstructive Pulmonary Disease (COPD) with spirometric Global Initiative for Chronic Obstructive Lung Disease Stage 1 to 3 4. Confirmed diagnosis of mild or moderate persistent asthma receiving guideline directed therapy 5. Confirmed diagnosis of chronic heart disease (New York Heart Association [NYHA] heart failure Class 1 to 3, receiving guideline-directed oral heart failure treatment) due to reduced or preserved ejection fraction or due to non-cyanotic congenital heart disease. 6. Current smoker - Female participant: not pregnant, not breastfeeding and 1) not of childbearing potential, or 2) of childbearing potential and agrees to practice contraception through 6 weeks after last administration of study vaccine. Exclusion Criteria: - History of active hepatitis within the prior 3 months - History of diabetic ketoacidosis, or >1 episodes of severe, symptomatic hypoglycemia within the prior 3 months - Myocardial infarction, acute coronary syndrome, transient ischemic attack, and ischemic or hemorrhagic stroke within the prior 3 months - History of severe pulmonary hypertension or history of Eisenmenger syndrome - History of invasive pneumococcal disease (IPD) or known history of other culture-positive pneumococcal disease within the prior 3 years - Known hypersensitivity to any vaccine component, pneumococcal conjugate vaccine, or diphtheria toxoid-containing vaccine - Known or suspected impairment of immunological function (including human immunodeficiency virus (HIV) infection or autoimmune disease) - History of malignancy within the prior 5 years, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer - History of Stage 4 or 5 Chronic Kidney Disease or nephrotic syndrome - History of alcohol withdrawal or alcohol withdrawal seizure within the prior 12 months - History of coagulation disorder contraindicating intramuscular vaccination - History of hospitalization within the prior 3 months - Planned organ transplantation (heart, liver, lung, kidney, or pancreas) or other planned major surgery during the duration of this study. - Expected survival for less than 1 year according to the investigator's judgment. - Female participant: positive urine or serum pregnancy test - Prior administration of any pneumococcal vaccine - Received systemic corticosteroids (prednisone equivalent of =20 mg/day) for =14 consecutive days and has not completed within the prior 30 days - Received systemic corticosteroids exceeding physiologic replacement doses within 14 days before study vaccination - Receiving immunosuppressive or immunomodulatory therapy with a biological agent - Received any licensed, non-live vaccine within 14 days before receipt of study vaccine or is scheduled to receive any licensed, non-live vaccine within 30 days following receipt of study vaccine - Received any live vaccine within 30 days before receipt of any study vaccine or is scheduled to receive any live vaccine within 30 days following receipt of any study vaccine - Received a blood transfusion or blood products within the prior 6 months - Receiving chronic home oxygen therapy - Participated in another clinical study of an investigational product within the prior 2 months - Current user of recreational or illicit drugs or history of drug abuse or dependence - Diabetes mellitus with HgA1c =10% - Chronic liver disease with Child-Pugh Class B or C cirrhosis - Chronic lung disease with Chronic Obstructive Pulmonary Disease (COPD) GOLD Stage 4 or severe persistent asthma - Chronic heart disease with NYHA heart failure Class 4.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
V114
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and Merck Aluminum Phosphate Adjuvant (125 mcg) in each 0.5 mL dose
Prevnar 13™
13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg), and aluminum phosphate adjuvant (125 mcg aluminum) in each 0.5 ml dose
PNEUMOVAX™23
23-valent pneumococcal polysaccharide vaccine with serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F (25 mcg each) in each 0.5 mL dose

Locations

Country Name City State
Australia Paratus Clinical Pty Ltd - Blacktown Clinic ( Site 0174) Blacktown New South Wales
Australia Core Research Group Pty limited ( Site 0175) Brisbane Queensland
Australia Emeritus Research Pty Ltd ( Site 0173) Camberwell Victoria
Australia Paratus Clinical Kanwal ( Site 0172) Kanwal
Australia Nepean Hospital ( Site 0176) Kingswood
Australia Holdsworth House Medical Practice ( Site 0170) Sydney New South Wales
Canada Hamilton Medical Research Group ( Site 0092) Hamilton Ontario
Canada Omnispec Recherche Clinique Inc ( Site 0093) Mirabel Quebec
Canada GA Research Associates, Ltd/Ltee ( Site 0303) Moncton New Brunswick
Canada SKDS Research Inc. ( Site 0099) Newmarket Ontario
Canada Dynamik Research ( Site 0095) Pointe-Claire Quebec
Canada Diex Recherche Quebec Inc ( Site 0091) Quebec
Canada Q & T Research Sherbrooke Inc. ( Site 0097) Sherbrooke Quebec
Canada Colchester Research Group ( Site 0094) Truro Nova Scotia
Canada The Liver and Intestinal Research Centre (LAIR) ( Site 0302) Vancouver British Columbia
Chile CECIM ( Site 0101) Santiago
Chile Centro de Investigacion Clinica UC CICUC ( Site 0104) Santiago
Chile CESFAM Esmeralda ( Site 0102) Santiago
Chile Clinica Arauco Salud ( Site 0100) Santiago RM
Chile Hospital Dr. Hernan Henriquez Aravena ( Site 0105) Temuco
New Zealand Auckland Clinical Studies Limited ( Site 0189) Auckland
New Zealand Optimal Clinical Trials ( Site 0182) Auckland
New Zealand Southern Clinical Trials - Waitemata ( Site 0183) Auckland
New Zealand Christchurch Heart Institute ( Site 0280) Christchurch
New Zealand Southern Clinical Trials Ltd ( Site 0180) Christchurch
New Zealand Lakeland Clinical Trials ( Site 0181) Rotorua
New Zealand Bay of Plenty Clinical School ( Site 0186) Tauranga
New Zealand P3 Research Ltd - Wellington ( Site 0184) Wellington
Poland Centrum Medyczne Pratia Bydgoszcz ( Site 0139) Bydgoszcz
Poland WSOZ im.T.Browicza w Bydgoszczy ( Site 0317) Bydgoszcz
Poland Synexus Polska Sp. z o.o. ( Site 0238) Gdansk
Poland Specjalistyczny osrodek .All-Med. Grazyna Pulka ( Site 0233) Krakow
Poland ID Clinic ( Site 0235) Myslowice
Poland Centrum Medyczne Ogrodowa Sp. Z o.o. ( Site 0319) Skierniewice
Poland Niepubliczny Zaklad Opieki Zdrowotnej ( Site 0314) Sopot
Poland Synexus Polska Sp. z o.o. oddzial we Wroclawiu ( Site 0234) Wroclaw
Poland Wroclawskie Centrum Zdrowia SP ZOZ ( Site 0236) Wroclaw
Russian Federation Republican Clinical Hospital of Infectious Diseases n. a. A.F.Agafonov ( Site 0249) Kazan
Russian Federation Saratov State Medical University n.a. V.I.Razumovskiy ( Site 0144) Saratov
Russian Federation Smolensk State Medical University ( Site 0246) Smolensk
United States Lehigh Valley Health Network ( Site 0040) Allentown Pennsylvania
United States Emory University School of Medicine at Grady Hospital ( Site 0027) Atlanta Georgia
United States Internal Medicine Associates [Bridgeton, NJ] ( Site 0015) Bridgeton New Jersey
United States Chinle Comprehensive Health Care Facility ( Site 0001) Chinle Arizona
United States Kootenai Health ( Site 0042) Coeur d'Alene Idaho
United States Corning Center For Clinical Research ( Site 0036) Corning New York
United States Top Medical Research, Inc ( Site 0033) Cutler Bay Florida
United States Evanston Premier Healthcare & Research, LLC. ( Site 0012) Evanston Illinois
United States Pharmakon Inc ( Site 0049) Evergreen Park Illinois
United States Fort Defiance Center for American Indian Health ( Site 0002) Fort Defiance Arizona
United States AIM Trials ( Site 0060) Fort Worth Texas
United States Gallup Center for American Indian Health ( Site 0003) Gallup New Mexico
United States University of Texas Medical Branch at Galveston ( Site 0034) Galveston Texas
United States Pulmonary Associates, PA ( Site 0043) Glendale Arizona
United States Mountain View Clinical Research ( Site 0007) Greer South Carolina
United States Indago Research & Health Center, Inc ( Site 0054) Hialeah Florida
United States Private Practice Leadership, LLC ( Site 0051) Houston Texas
United States Texas Center For Drug Development ( Site 0041) Houston Texas
United States The Center for Pharmaceutical Research PC ( Site 0050) Kansas City Missouri
United States Holston Medical Group ( Site 0025) Kingsport Tennessee
United States Gundersen Health System ( Site 0021) La Crosse Wisconsin
United States Clinical Research Consortium ( Site 0053) Las Vegas Nevada
United States Marshfield Clinic ( Site 0013) Marshfield Wisconsin
United States Texas Institute Of Cardiology ( Site 0048) McKinney Texas
United States Mid Hudson Medical Research ( Site 0022) New Windsor New York
United States Renstar Medical Research ( Site 0008) Ocala Florida
United States University of Pennsylvania ( Site 0030) Philadelphia Pennsylvania
United States Central Phoenix Medical Clinic, LLC ( Site 0031) Phoenix Arizona
United States Village Health Partners ( Site 0006) Plano Texas
United States Wake Research Associates, LLC ( Site 0016) Raleigh North Carolina
United States Inland Empire Clinical Trials, LLC ( Site 0052) Rialto California
United States Reid Physician Associates ( Site 0055) Richmond Indiana
United States Shiprock Center for American Indian Health ( Site 0004) Shiprock New Mexico
United States Timber Lane Allergy & Asthma Research, LLC ( Site 0044) South Burlington Vermont
United States Copperview Medical Center ( Site 0038) South Jordan Utah
United States Pulmonary & Sleep Research ( Site 0046) Spokane Valley Washington
United States Triple O Research Institute, P.A. ( Site 0026) West Palm Beach Florida
United States Whiteriver Center for American Indian Health ( Site 0005) Whiteriver Arizona

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Chile,  New Zealand,  Poland,  Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Solicited Injection-site Adverse Events Following V114 or Prevnar 13™ An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following Vaccination 1 with either V114 or Prevnar 13™, the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain. Estimated confidence intervals (CIs) are calculated based on the exact binomial method proposed by Clopper and Pearson. Up to 5 days after Vaccination 1
Primary Percentage of Participants With Solicited Systemic Adverse Events Following V114 or Prevnar 13™ An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following vaccination with V114 or Prevnar 13™, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson. Up to 14 days after Vaccination 1
Primary Percentage of Participants With a Vaccine-related Serious Adverse Event Following V114 or Prevnar 13™ A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine was determined by the investigator. Following vaccination with V114 or Prevnar 13™, the percentage of serious adverse events of V114 compared with Prevnar 13™ was assessed. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson. Up to Month 6 (before Vaccination 2)
Primary Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™ The geometric mean titer (GMT) of serotype-specific opsonophagocytic activity (OPA) for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a multiplex opsonophagocytic assay. The within-group 95% CIs are obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. Day 30
Secondary Percentage of Participants With Solicited Injection-site Adverse Events Following PNEUMOVAX™23 An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following Vaccination 2 with PNEUMOVAX™23, the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson and are provided in accordance with the statistical analysis plan. Up to 5 days after Vaccination 2 (Month 6)
Secondary Percentage of Participants With Solicited Systemic Adverse Events Following PNEUMOVAX™23 An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following Vaccination 2 with PNEUMOVAX™23, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson. Up to 14 days after Vaccination 2 (Month 6)
Secondary Percentage of Participants With a Vaccine-related Serious Adverse Event Following PNEUMOVAX™23 A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine was determined by the investigator. Following vaccination with PNEUMOVAX™23, the percentage of serious adverse events of V114 compared with Prevnar 13™ was assessed. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson. From Month 6 (before Vaccination 2) to Month 7
Secondary Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30 The geometric mean concentration (GMC) of serotype-specific immunoglobulin G (IgG) for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. The within-group 95% CIs are obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. Day 30
Secondary Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplex Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination. Day 1 (Baseline) and Day 30
Secondary GMFR in Serotype-specific IgG Day 1 to Day 30 IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination. Day 1 (Baseline) and Day 30
Secondary Percentage of Participants With =4-Fold Rise in Serotype-specific OPA Day 1 to Day 30 Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. The percentage of participants who had =4-fold rise in OPA titers were calculated from baseline to postvaccination. Day 1 (Baseline) and Day 30
Secondary Percentage of Participants With =4-Fold Rise in Serotype-specific IgG Day 1 to Day 30 IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. The percentage of participants who had = 4-fold rise in IgG concentration are calculated from baseline to postvaccination. Day 1 (Baseline) and Day 30
Secondary Geometric Mean Titer of Serotype-specific OPA at Month 7 The geometric mean titer (GMT) of serotype-specific OPA for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a multiplex opsonophagocytic assay. The within-group 95% CIs are obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. Month 7
Secondary Geometric Mean Concentration of Serotype-specific IgG at Month 7 The geometric mean concentration (GMC) of serotype-specific immunoglobulin G (IgG) for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. Month 7
Secondary GMFR in Serotype-specific OPA Day 1 to Month 7 Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination. Day 1 (Baseline) and Month 7
Secondary GMFR in Serotype-specific IgG Day 1 to Month 7 IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination. Day 1 (Baseline) and Month 7
Secondary Percentage of Participants With =4-Fold Rise in Serotype-specific OPA Day 1 to Month 7 Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. The percentage of participants who had =4-fold rise in OPA titers were calculated from baseline to postvaccination. Day 1 (Baseline) and Month 7
Secondary Percentage of Participants With =4-Fold Rise in Serotype-specific IgG Day 1 to Month 7 IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. The percentage of participants who had = 4-fold rise in IgG concentration are calculated from baseline to postvaccination. Day 1 (Baseline) and Month 7
Secondary GMFR in Serotype-specific OPA Month 6 to Month 7 Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using the Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination. Month 6 (Baseline before Vaccination 2) and Month 7
Secondary GMFR in Serotype-specific IgG Month 6 to Month 7 IgG for the serotypes contained in Prevnar 13™ and V114 and (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination. Month 6 (Baseline before Vaccination 2) and Month 7
Secondary Percentage of Participants With =4-Fold Rise in Serotype-specific OPA Month 6 to Month 7 Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. The percentage of participants who had =4-fold rise in OPA titers were calculated from baseline to postvaccination. Month 6 (Baseline before Vaccination 2) and Month 7
Secondary Percentage of Participants With =4-Fold Rise in Serotype-specific IgG Month 6 to Month 7 IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. The percentage of participants who had = 4-fold rise in IgG concentration are calculated from baseline to postvaccination. Month 6 (Baseline before Vaccination 2) and Month 7
See also
  Status Clinical Trial Phase
Completed NCT02201030 - Immunogenicity and Safety Study of NBP606 in Healthy Infants Phase 3
Completed NCT02787863 - Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology Phase 4
Completed NCT04031846 - Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-025) Phase 3
Recruiting NCT05920499 - The Effect of AUDIT and Feedback on Pneumococcal Vaccination Coverage N/A
Completed NCT01215175 - Safety and Tolerability Study for the Pneumococcal Conjugate Vaccine V114 Versus Prevnar™ (V114-001) Phase 1
Completed NCT02892812 - A Phase I Clinical Trial of a 13-valent Pneumococcal Conjugate Vaccine and 14-valent Pneumococcal Conjugate Vaccine in Adults Phase 1
Completed NCT02116998 - Safety, Tolerability, and Efficacy Study of Prophylactic S. Pneumoniae Vaccine Following Challenge With S. Pneumoniae Phase 2
Completed NCT01446926 - Study of Investigational Pneumococcal Vaccine in Healthy Adults, Toddlers and Infants Phase 1
Completed NCT01193582 - A Study To Assess The Safety And Effectiveness Of Prevenar In Chinese Children Who Have Not Previously Received A Vaccine Against Pneumococcal Bacteria Phase 4
Completed NCT00744263 - Study Evaluating the Effiacy of a 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) in Adults Phase 4
Completed NCT00492557 - Study Evaluating Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine With Influenza Vaccine in Adults Phase 3
Completed NCT00195611 - Study of Streptococcus Pneumoniae in Nose and Throats of Infants With Acute Otitis Media Phase 4
Completed NCT00205803 - Study Evaluating Pneumococcal Vaccine in Healthy Infants Phase 1/Phase 2
Completed NCT00137605 - Early Versus Delayed Pneumococcal Vaccination in HIV Phase 1/Phase 2
Completed NCT02531373 - A Study to Evaluate the Safety, Tolerability and Immunogenicity of V114 in Healthy Adults and Infants (V114-005) Phase 1/Phase 2
Completed NCT03615482 - A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 When Administered Concomitantly With Influenza Vaccine in Healthy Adults 50 Years of Age or Older (V114-021/PNEU-FLU) Phase 3
Completed NCT03565900 - A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Allogeneic Hematopoietic Stem Cell Transplant Recipients (V114-022/PNEU-STEM) Phase 3
Completed NCT04989465 - A Clinical Trial of 23-valent Pneumococcal Polysaccharide Vaccine Phase 4
Completed NCT02547649 - Safety, Tolerability, and Immunogenicity of Two Formulations of V114 in Healthy Adults 50 Years of Age or Older (V114-006) Phase 2
Completed NCT02573181 - Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in PPSV23-vaccinated Healthy Adults ≥65 Years of Age (V114-007) Phase 2