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A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Adults at Increased Risk for Pneumococcal Disease (V114-017/PNEU-DAY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03547167
Recruitment Status : Active, not recruiting
First Posted : June 6, 2018
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief 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 3) living in a community/environment with increased risk of disease transmission.

Condition or disease Intervention/treatment Phase
Pneumococcal Infections Biological: V114 Biological: Prevnar 13™ Biological: PNEUMOVAX™23 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by Administration of PNEUMOVAX™23 Six Months Later in Immunocompetent Adults Between 18 and 49 Years of Age at Increased Risk for Pneumococcal Disease (PNEU - DAY)
Actual Study Start Date : July 16, 2018
Estimated Primary Completion Date : January 17, 2020
Estimated Study Completion Date : January 17, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: V114
Participants will receive a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2)
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

Biological: 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

Active Comparator: Prevnar 13™
Participants will receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2)
Biological: 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

Biological: 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




Primary Outcome Measures :
  1. Percentage of Participants with a Solicited Injection-site Adverse Event [ Time Frame: Up to Day 5 after Vaccination 1 ]
    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. Solicited injection-site AEs will be redness/erythema, swelling, and pain/tenderness.

  2. Percentage of Participants with a Solicited Systemic Adverse Event [ Time Frame: Up to Day 14 after Vaccination 1 ]
    An 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. Solicited systemic AEs will be muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue.

  3. Percentage of Participants with a Vaccine-related Serious Adverse Event [ Time Frame: Up to Month 6 (before Vaccination 2) ]
    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 will be determined by the investigator.

  4. Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) [ Time Frame: Day 30 ]
    Activity for the 15 serotypes contained in V114 vaccine will be determined using a Multiplex Opsonophagocytic Assay.


Secondary Outcome Measures :
  1. Percentage of Participants with a Solicited Injection-site Adverse Event [ Time Frame: Up to Day 5 after Vaccination 2 (Month 6) ]
    An 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. Solicited injection-site AEs will be redness/erythema, swelling, and pain/tenderness.

  2. Percentage of Participants with a Solicited Systemic Adverse Event [ Time Frame: Up to Day 14 after Vaccination 2 (Month 6) ]
    An 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. Solicited systemic AEs will be muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue.

  3. Percentage of Participants with a Vaccine-related Serious Adverse Event [ Time Frame: From Month 6 (before Vaccination 2) to Month 7 ]
    An 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 will be determined by the investigator.

  4. Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) [ Time Frame: Day 30 ]
    Immunoglobulin G for the 15 serotypes contained in V114 vaccine will be determined using an electrochemiluminescence assay.

  5. Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA [ Time Frame: Day 1 (Baseline) and Day 30 ]
    Activity for the 15 serotypes contained in V114 vaccine will be determined using a Multiplex Opsonophagocytic Assay. GMFR is GMT at Day 30 / GMT at Day 1.

  6. GMFR in Serotype-specific IgG [ Time Frame: Day 1 (Baseline) and Day 30 ]
    Immunoglobulin G for the 15 serotypes contained in V114 vaccine will be determined using an electrochemiluminescence assay. GMFR is GMC at Day 30 / GMC at Day 1.

  7. Percentage of Participants with GMFR ≥4 in Serotype-specific OPA [ Time Frame: Day 1 (Baseline) and Day 30 ]
    Activity for the 15 serotypes contained in V114 vaccine will be determined using a Multiplex Opsonophagocytic Assay.

  8. Percentage of Participants with GMFR ≥4 in Serotype-specific IgG [ Time Frame: Day 1 (Baseline) and Day 30 ]
    Immunoglobulin G for the 15 serotypes contained in V114 vaccine will be determined using an electrochemiluminescence assay.

  9. Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity [ Time Frame: Month 7 ]
    Activity for the 15 serotypes contained in V114 vaccine will be determined using a Multiplex Opsonophagocytic Assay.

  10. Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) [ Time Frame: Month 7 ]
    Immunoglobulin G for the 15 serotypes contained in V114 vaccine will be determined using an electrochemiluminescence assay.

  11. GMFR in Serotype-specific OPA [ Time Frame: Day 1 (Baseline) and Month 7 ]
    Activity for the 15 serotypes contained in V114 vaccine will be determined using a Multiplex Opsonophagocytic Assay. GMFR is GMT at Month 7 / GMT at Day 1.

  12. GMFR in Serotype-specific IgG [ Time Frame: Day 1 (Baseline) and Month 7 ]
    Immunoglobulin G for the 15 serotypes contained in V114 vaccine will be determined using an electrochemiluminescence assay. GMFR is GMC at Month 7 / GMC at Day 1.

  13. Percentage of Participants with GMFR ≥4 in Serotype-specific OPA [ Time Frame: Day 1 (Baseline) and Month 7 ]
    Activity for the 15 serotypes contained in V114 vaccine will be determined using a Multiplex Opsonophagocytic Assay.

  14. Percentage of Participants with GMFR ≥4 in Serotype-specific IgG [ Time Frame: Day 1 (Baseline) and Month 7 ]
    Immunoglobulin G for the 15 serotypes contained in V114 vaccine will be determined using an electrochemiluminescence assay.

  15. GMFR in Serotype-specific OPA [ Time Frame: Month 6 (Baseline before Vaccination 2) and Month 7 ]
    Activity for the 15 serotypes contained in V114 vaccine will be determined using a Multiplex Opsonophagocytic Assay. GMFR is GMT at Month 7 / GMT at Month 6.

  16. GMFR in Serotype-specific IgG [ Time Frame: Month 6 (Baseline before Vaccination 2) and Month 7 ]
    Immunoglobulin G for the 15 serotypes contained in V114 vaccine will be determined using an electrochemiluminescence assay. GMFR is GMC at Month 7 / GMC at Month 6.

  17. Percentage of Participants with GMFR ≥4 in Serotype-specific OPA [ Time Frame: Month 6 (Baseline before Vaccination 2) and Month 7 ]
    Activity for the 15 serotypes contained in V114 vaccine will be determined using a Multiplex Opsonophagocytic Assay.

  18. Percentage of Participants with GMFR ≥4 in Serotype-specific IgG [ Time Frame: Month 6 (Baseline before Vaccination 2) and Month 7 ]
    Immunoglobulin G for the 15 serotypes contained in V114 vaccine will be determined using an electrochemiluminescence assay.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 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 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 - 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 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03547167


  Hide Study Locations
Locations
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United States, Arizona
Chinle Comprehensive Health Care Facility ( Site 0001)
Chinle, Arizona, United States, 86503
Fort Defiance Center for American Indian Health ( Site 0002)
Fort Defiance, Arizona, United States, 86504
Pulmonary Associates, PA ( Site 0043)
Glendale, Arizona, United States, 85306
Central Phoenix Medical Clinic, LLC ( Site 0031)
Phoenix, Arizona, United States, 85020
Whiteriver Center for American Indian Health ( Site 0005)
Whiteriver, Arizona, United States, 85941
United States, California
Inland Empire Clinical Trials, LLC ( Site 0052)
Rialto, California, United States, 92377
United States, Florida
Top Medical Research, Inc ( Site 0033)
Cutler Bay, Florida, United States, 33189
Indago Research & Health Center, Inc ( Site 0054)
Hialeah, Florida, United States, 33012
Renstar Medical Research ( Site 0008)
Ocala, Florida, United States, 34471
Triple O Research Institute, P.A. ( Site 0026)
West Palm Beach, Florida, United States, 33407
United States, Georgia
Emory University School of Medicine at Grady Hospital ( Site 0027)
Atlanta, Georgia, United States, 30303
United States, Idaho
Kootenai Health ( Site 0042)
Coeur d'Alene, Idaho, United States, 83814
United States, Illinois
Evanston Premier Healthcare & Research, LLC. ( Site 0012)
Evanston, Illinois, United States, 60201
Pharmakon Inc ( Site 0049)
Evergreen Park, Illinois, United States, 60805
United States, Indiana
Reid Physician Associates ( Site 0055)
Richmond, Indiana, United States, 47374
United States, Missouri
The Center for Pharmaceutical Research PC ( Site 0050)
Kansas City, Missouri, United States, 64114
United States, Nevada
Clinical Research Consortium ( Site 0053)
Las Vegas, Nevada, United States, 89119
United States, New Jersey
Internal Medicine Associates [Bridgeton, NJ] ( Site 0015)
Bridgeton, New Jersey, United States, 08302
United States, New Mexico
Gallup Center for American Indian Health ( Site 0003)
Gallup, New Mexico, United States, 87301
Shiprock Center for American Indian Health ( Site 0004)
Shiprock, New Mexico, United States, 87420
United States, New York
Corning Center For Clinical Research ( Site 0036)
Corning, New York, United States, 14830
Mid Hudson Medical Research ( Site 0022)
New Windsor, New York, United States, 12553
United States, North Carolina
Wake Research Associates, LLC ( Site 0016)
Raleigh, North Carolina, United States, 27612
United States, Pennsylvania
Lehigh Valley Health Network ( Site 0040)
Allentown, Pennsylvania, United States, 18102
University of Pennsylvania ( Site 0030)
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Mountain View Clinical Research ( Site 0007)
Greer, South Carolina, United States, 29651
United States, Tennessee
Holston Medical Group ( Site 0025)
Kingsport, Tennessee, United States, 37660
United States, Texas
AIM Trials ( Site 0060)
Fort Worth, Texas, United States, 76104
University of Texas Medical Branch at Galveston ( Site 0034)
Galveston, Texas, United States, 77555-1115
Private Practice Leadership, LLC ( Site 0051)
Houston, Texas, United States, 77094
Texas Center For Drug Development ( Site 0041)
Houston, Texas, United States, 77801
Texas Institute Of Cardiology ( Site 0048)
McKinney, Texas, United States, 75071
Village Health Partners ( Site 0006)
Plano, Texas, United States, 75024
United States, Utah
Copperview Medical Center ( Site 0038)
South Jordan, Utah, United States, 84095
United States, Vermont
Timber Lane Allergy & Asthma Research, LLC ( Site 0044)
South Burlington, Vermont, United States, 05403
United States, Washington
Pulmonary & Sleep Research ( Site 0046)
Spokane Valley, Washington, United States, 99216
United States, Wisconsin
Gundersen Health System ( Site 0021)
La Crosse, Wisconsin, United States, 54601
Marshfield Clinic ( Site 0013)
Marshfield, Wisconsin, United States, 54449
Australia, New South Wales
Paratus Clinical Pty Ltd - Blacktown Clinic ( Site 0174)
Blacktown, New South Wales, Australia, 2148
Holdsworth House Medical Practice ( Site 0170)
Sydney, New South Wales, Australia, 2010
Australia, Queensland
Core Research Group Pty limited ( Site 0175)
Brisbane, Queensland, Australia, 4064
Australia, Victoria
Emeritus Research Pty Ltd ( Site 0173)
Camberwell, Victoria, Australia, 3124
Australia
Paratus Clinical Kanwal ( Site 0172)
Kanwal, Australia, 2259
Nepean Hospital ( Site 0176)
Kingswood, Australia, 2747
Canada, British Columbia
The Liver and Intestinal Research Centre (LAIR) ( Site 0302)
Vancouver, British Columbia, Canada, V5Z 1H2
Canada, New Brunswick
GA Research Associates, Ltd/Ltee ( Site 0303)
Moncton, New Brunswick, Canada, E1G 1A7
Canada, Nova Scotia
Colchester Research Group ( Site 0094)
Truro, Nova Scotia, Canada, B2N 1L2
Canada, Ontario
Hamilton Medical Research Group ( Site 0092)
Hamilton, Ontario, Canada, L8M 1K7
SKDS Research Inc. ( Site 0099)
Newmarket, Ontario, Canada, L3Y 5G8
Canada, Quebec
Omnispec Recherche Clinique Inc ( Site 0093)
Mirabel, Quebec, Canada, J7J 2K8
Dynamik Research ( Site 0095)
Pointe-Claire, Quebec, Canada, H9R 3J1
Q & T Research Sherbrooke Inc. ( Site 0097)
Sherbrooke, Quebec, Canada, J1J 2G2
Canada
Diex Recherche Quebec Inc ( Site 0091)
Quebec, Canada, G1N 4V3
Chile
Clinica Arauco Salud ( Site 0100)
Santiago, RM, Chile, 7560994
Centro de Investigacion Clinica UC CICUC ( Site 0104)
Santiago, Chile, 8330034
CECIM ( Site 0101)
Santiago, Chile, 8330336
CESFAM Esmeralda ( Site 0102)
Santiago, Chile, 9351603
Hospital Dr. Hernan Henriquez Aravena ( Site 0105)
Temuco, Chile, 4781151
New Zealand
Southern Clinical Trials - Waitemata ( Site 0183)
Auckland, New Zealand, 0626
Auckland Clinical Studies Limited ( Site 0189)
Auckland, New Zealand, 1010
Optimal Clinical Trials ( Site 0182)
Auckland, New Zealand, 1010
Christchurch Heart Institute ( Site 0280)
Christchurch, New Zealand, 8011
Southern Clinical Trials Ltd ( Site 0180)
Christchurch, New Zealand, 8013
Lakeland Clinical Trials ( Site 0181)
Rotorua, New Zealand, 3010
Bay of Plenty Clinical School ( Site 0186)
Tauranga, New Zealand, 3143
P3 Research Ltd - Wellington ( Site 0184)
Wellington, New Zealand, 6021
Poland
WSOZ im.T.Browicza w Bydgoszczy ( Site 0317)
Bydgoszcz, Poland, 85-030
Centrum Medyczne Pratia Bydgoszcz ( Site 0139)
Bydgoszcz, Poland, 85-796
Synexus Polska Sp. z o.o. ( Site 0238)
Gdansk, Poland, 80-382
Specjalistyczny osrodek .All-Med. Grazyna Pulka ( Site 0233)
Krakow, Poland, 30-033
ID Clinic ( Site 0235)
Myslowice, Poland, 41-400
Centrum Medyczne Ogrodowa Sp. Z o.o. ( Site 0319)
Skierniewice, Poland, 96-100
Niepubliczny Zaklad Opieki Zdrowotnej ( Site 0314)
Sopot, Poland, 81-717
Wroclawskie Centrum Zdrowia SP ZOZ ( Site 0236)
Wroclaw, Poland, 50-136
Synexus Polska Sp. z o.o. oddział we Wrocławiu ( Site 0234)
Wroclaw, Poland, 50-381
Russian Federation
Republican Clinical Hospital of Infectious Diseases n. a. A.F.Agafonov ( Site 0249)
Kazan, Russian Federation, 420140
Saratov State Medical University n.a. V.I.Razumovskiy ( Site 0144)
Saratov, Russian Federation, 410054
Smolensk State Medical University ( Site 0246)
Smolensk, Russian Federation, 214019
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.

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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT03547167     History of Changes
Other Study ID Numbers: V114-017
2017-004915-38 ( EudraCT Number )
V114-017 ( Other Identifier: Merck Protocol Number )
First Posted: June 6, 2018    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs