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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03893448
Recruitment Status : Recruiting
First Posted : March 28, 2019
Last Update Posted : December 6, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 superior to Prevnar 13™ for the 2 serotypes unique to V114 based on response rates at 30 days following Dose 3; 3) V114 is non-inferior to Prevnar 13™ based on anti-pneumococcal polysaccharide (PnPs) serotype-specific immunoglobulin g (IgG) geometric mean concentrations (GMCs) at 30 days following Dose 3; 4) V114 is superior to Prevnar 13™ for the 2 serotypes unique to V114 based on anti-PnPs serotype-specific IgG GMCs 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 superior to Prevnar 13™ for the 2 serotypes unique to V114 based on anti-PnPs serotype-specific IgG GMCs at 30 days following Dose 4.

Condition or disease Intervention/treatment Phase
Pneumococcal Infections Pneumococcal Vaccines Biological: V114 Biological: Prevnar 13™ Biological: RotaTeq™ Biological: Pentacel™ Biological: RECOMBIVAX HB™ Biological: VAQTA™ Biological: M-M-R™ Biological: VARIVAX™ Biological: HIBERIX™ Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1720 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 a 4-dose Regimen of V114 in Healthy Infants (PNEU-PED)
Actual Study Start Date : June 19, 2019
Estimated Primary Completion Date : December 22, 2020
Estimated Study Completion Date : May 20, 2021

Arm Intervention/treatment
Experimental: V114
Participants receive 4 total 0.5 mL intramuscular (IM) vaccinations at ~2, 4, 6, and 12 to 15 months of age. Participants will receive other vaccinations (i.e., RotaTeq™, Pentacel™, RECOMBIVAX HB™, VAQTA™, M-M-R II™, VARIVAX™, and HIBERIX™) as part of their vaccination schedule.
Biological: V114
V114 15-valent pneumococcal conjugate vaccine containing 13 serotypes present in Prevnar 13® (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) and 2 unique serotypes (22F and 33F) in each 0.5 mL intramuscular administration.

Biological: RotaTeq™
A total of 3 RotaTeq™ 2 mL oral dosings at ~2, 4, and 6 months of age.

Biological: Pentacel™
A total of 3 Pentacel™ 0.5 mL IM dosings at ~2, 4, and 6 months of age.

Biological: RECOMBIVAX HB™
A total of 3 RECOMBIVAX HB™ 0.5 mL IM dosings at ~2, 4, and 6 months of age.

Biological: VAQTA™
One VAQTA™ 0.5 mL IM dosing at 12 to 15 months of age.

Biological: M-M-R™
One M-M-R™ 0.5 mL subcutaneous (SC) dosing at 12 to 15 months of age.

Biological: VARIVAX™
One VARIVAX™ 0.5 mL SC dosing at 12 to 15 months of age.

Biological: HIBERIX™
One HIBERIX™ 0.5 mL IM dosing at Visit 5.

Active Comparator: Prevnar 13™
Participants receive 4 total 0.5 mL IM vaccinations at ~2, 4, 6, and 12 to 15 months of age. Participants will also receive other vaccines (i.e., RotaTeq™, Pentacel™, RECOMBIVAX HB™, VAQTA™, M-M-R II™, VARIVAX™, and HIBERIX™) as part of their vaccination schedule.
Biological: Prevnar 13™
Prevnar 13™ 13-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in each 0.5 mL IM administration.

Biological: RotaTeq™
A total of 3 RotaTeq™ 2 mL oral dosings at ~2, 4, and 6 months of age.

Biological: Pentacel™
A total of 3 Pentacel™ 0.5 mL IM dosings at ~2, 4, and 6 months of age.

Biological: RECOMBIVAX HB™
A total of 3 RECOMBIVAX HB™ 0.5 mL IM dosings at ~2, 4, and 6 months of age.

Biological: VAQTA™
One VAQTA™ 0.5 mL IM dosing at 12 to 15 months of age.

Biological: M-M-R™
One M-M-R™ 0.5 mL subcutaneous (SC) dosing at 12 to 15 months of age.

Biological: VARIVAX™
One VARIVAX™ 0.5 mL SC dosing at 12 to 15 months of age.

Biological: HIBERIX™
One HIBERIX™ 0.5 mL IM dosing at Visit 5.




Primary Outcome Measures :
  1. Percentage of Participants with Solicited Injection-Site Adverse Events (AEs) [ Time Frame: Up to 14 days after each vaccination ]
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs will consist of swelling, redness, pain or tenderness, and hard lump.

  2. Percentage of Participants with Solicited Systemic Adverse Events (AEs) [ Time Frame: Up to 6 months after Vaccination 4 (up to 21 months) ]
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs will consist of irritability, drowsiness, appetite lost, and hives or welts.

  3. Percentage of Participants with Vaccine-Related Serious Adverse Events (SAEs) [ Time Frame: Up to 6 months after Vaccination 4 (up to 21 months) ]
    An SAE is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an other important medical event. Any SAEs that are at least possibly related to vaccination will be summarized.

  4. Percentage of Participants with Anti-Pneumococcal Polysaccharide (anti-PNP) Immunoglobulin G (IgG) Antibody (Ab) Titers ≥0.35 µg/mL One Month After Vaccination 3 [ Time Frame: One month after Vaccination 3 (Month 7) ]
    Anti-PNP serotype-specific IgG responses for the 15 serotypes contained in V114 will be measured with pneumococcal electrochemiluminescence (PnECL). The percentage of participants with IgG Ab titers ≥0.35 µg/mL will be reported for each serotype.

  5. Geometric Mean Concentrations (GMCs) of Anti-Pneumococcal Polysaccharide (anti-PNP) Immunoglobulin G (IgG) Antibody (Ab) Titers One Month After Vaccination 3 [ Time Frame: One month after Vaccination 3 (Month 7) ]
    Antibody levels will be measured with pneumococcal electrochemiluminescence (PnECL).

  6. Geometric Mean Concentrations (GMCs) of Anti-Pneumococcal Polysaccharide (anti-PNP) Immunoglobulin G (IgG) Antibody (Ab) Titers One Month After Vaccination 4 [ Time Frame: One month after Vaccination 4 (Month 13 to Month 16) ]
    Antibody levels will be measured with pneumococcal electrochemiluminescence (PnECL).


Secondary Outcome Measures :
  1. Percentage of Participants with Pentacel™-Specific Anti-Pneumococcal Polysaccharide (anti-PNP) Immunoglobulin G (IgG) Antibody (Ab) Titers Meeting Seotype-Specific Response Rate Criteria One Month After Vaccination 3 [ Time Frame: One month after Vaccination 3 (Month 7) ]
    Antibody responses to each antigen contained in Pentacel™ will be determined among participants in each arm who receive Pentacel™ as part of routine vaccination using pneumococcal electrochemiluminescence (PnECL). The percentage of participants meeting specific criteria will be summarized for each serotype. The serotype-specific response rate criteria are as follows: diphtheria toxoid: % ≥0.1 IU/mL; tetanus toxoid: % ≥0.1 IU/mL; pertussis toxin (PT): % ≥ 5 EU/mL; pertussis filamentous hemagglutinin (FHA): % ≥5 EU/mL; pertussis fimbrae types 2/3 (FIM 2/3): % ≥20 EU/mL; pertussis pertactin (PRN): % ≥5 EU/mL; poliovirus 1: % ≥1:8 dilution; poliovirus 2: % ≥1:8 dilution, poliovirus 3: % ≥1:8 dilution; and Haemophilus influenzae Type B polyribosylribitol phosphate (Hib PRP): % ≥0.15 µg/mL.

  2. Hepatitis A Antibody Response Rate One Month After Vaccination 4 [ Time Frame: One month after Vaccination 4 (Month 13 to Month 16) ]
    Antibody response rates to hepatitis A will be measured with hepatitis A virus enzyme immunoassay (HAV EIA). The percentage of participants with hepatitis A antigen ≥10 mIU/mL will be determined.

  3. Measles, Mumps, and Rubella Antibody Response Rate One Month After Vaccination 4 [ Time Frame: One month after Vaccination 4 (Month 13 to Month 16) ]
    Antibody responses to measles will be measured with the bulk measles immunoglobulin G (IgG) enzyme immunoassay (EIA). Antibody responses to mumps will be measured with enzyme-linked immunosorbent assay (ELISA). Antibody responses to rubella will be measured with Bulk Rubella IgG EIA. The percentage of participants with measles antigen ≥255 mIU/ML; mumps antigen ≥10 mumps Ab units/mL; and rubella antigen ≥10 IU/mL, will be determined.

  4. Varicella-Zoster Virus (VZV) Antibody Response Rate One Month After Vaccination 4 [ Time Frame: One month after Vaccination 4 (Month 13 to Month 16) ]
    Antibody responses to varicella-zoster virus will be measured with glycoprotein enzyme-linked immunosorbent assay (gpELISA). The percentage of participants with VZV antigen ≥5 gpELISA units/mL will be determined.

  5. Haemophilus Influenzae Type B Antibody Response Rate One Month After Vaccination 4 [ Time Frame: One month after Vaccination 4 (Month 13 to Month 16) ]
    Antibody responses to Haemophilus influenzae Type B polyribosylribitol phosphate (Hib PRP) will be measured with enzyme-linked immunosorbent assay (ELISA). The percentage of participants with anti-HiB PRP antigen ≥0.15 µg/mL will be determined.

  6. Anti-Pneumococcal Polysaccharide (anti-PNP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) One Month After Vaccination 3 [ Time Frame: One month after Vaccination 3 (Month 7) ]
    Serotype-specific anti-PNP OPA GMTs will be measured with pneumococcal electrochemiluminescence (PnECL). The GMTs for each serotype will be summarized.

  7. Anti-Pneumococcal Polysaccharide (anti-PNP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3 [ Time Frame: One month after Vaccination 3 (Month 7) ]
    Serotype-specific anti-PNP OPA GMTs will be measured with pneumococcal electrochemiluminescence (PnECL). The percentage of participants with OPA GMTs ≥0.35 µg/mL will be reported for each serotype.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   42 Days to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Is healthy (based on a review of medical history and physical examination) in the clinical judgement of the investigator
  • Has a legally acceptable representative who understands the study procedures, alternate treatments available, and risks involved with the study and voluntarily agrees to participate by giving written informed consent.

Exclusion Criteria:

  • Has a history of invasive pneumococcal disease (IPD; positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease.
  • Has a known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV), any component of the licensed pediatric vaccines to be administered concomitantly in the study, or any diphtheria toxoid-containing vaccine.
  • Has any contraindication to the concomitant study vaccines being administered in the study.
  • Had a recent febrile illness (rectal temperature =38.1°C [=100.5°F] or axillary temperature =37.8°C [=100.0°F]) occurring within 72 hours prior to receipt of study vaccine.

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): NCT03893448


Contacts
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Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com

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Locations
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United States, Alabama
Alabama Clinical Therapeutics ( Site 0159) Recruiting
Birmingham, Alabama, United States, 35205
Contact: Study Coordinator    205-933-8522      
Southeastern Pediatric Associates, P.A. ( Site 0107) Recruiting
Dothan, Alabama, United States, 36305
Contact: Study Coordinator    334-794-8656      
South Alabama Pediatrics ( Site 0263) Recruiting
Opp, Alabama, United States, 36467
Contact: Study Coordinator    251-533-6554      
United States, Arkansas
Northwest Arkansas Pediatric Clinic ( Site 0172) Recruiting
Fayetteville, Arkansas, United States, 72703
Contact: Study Coordinator    479-571-7192      
Children's Clinic of Jonesboro, PA ( Site 0184) Recruiting
Jonesboro, Arkansas, United States, 72401
Contact: Study Coordinator    870-934-3133      
United States, California
Advanced Clinical Research - Rancho Paseo ( Site 0163) Recruiting
Banning, California, United States, 92220
Contact: Study Coordinator    951-755-0223      
Altissima Clinical Research LLC ( Site 0213) Recruiting
Bellflower, California, United States, 90706
Contact: Study Coordinator    562-229-6562      
Southland Clinical Research Center ( Site 0187) Recruiting
Bellflower, California, United States, 90706
Contact: Study Coordinator    562-925-2625      
Premier Health Research Center, LLC ( Site 0121) Recruiting
Downey, California, United States, 90240
Contact: Study Coordinator    562-904-2123      
Kaiser Permanente - Sacramento ( Site 0257) Recruiting
Sacramento, California, United States, 95815
Contact: Study Coordinator    510-267-7538      
Kaiser Permanente Vaccine Study Center - South Sacramento ( Site 0256) Recruiting
Sacramento, California, United States, 95823
Contact: Study Coordinator    510-267-7538      
Kaiser Permanente - San Jose ( Site 0258) Recruiting
San Jose, California, United States, 95119
Contact: Study Coordinator    510-267-7538      
Kaiser Permanente - Santa Clara ( Site 0244) Recruiting
Santa Clara, California, United States, 95051
Contact: Study Coordinator    510-267-7538      
Kaiser Permanente - Santa Clara ( Site 0282) Recruiting
Santa Clara, California, United States, 95051
Contact: Study Coordinator    510-267-7538      
United States, Colorado
Davita Medical Group ( Site 0141) Recruiting
Colorado Springs, Colorado, United States, 80922
Contact: Study Coordinator    719-570-0607      
United States, Florida
Suncoast Research Associates, LLC ( Site 0250) Recruiting
Miami, Florida, United States, 33184
Contact: Study Coordinator    786-623-3135      
Suncoast Research Associates, LLC ( Site 0249) Recruiting
North Miami Beach, Florida, United States, 33160
Contact: Study Coordinator    786-623-3135      
Children's Health Center ( Site 0272) Recruiting
Tampa, Florida, United States, 33617
Contact: Study Coordinator    813-899-1394      
United States, Idaho
Saltzer Medical Group ( Site 0215) Recruiting
Nampa, Idaho, United States, 83686
Contact: Study Coordinator    208-463-3163      
United States, Kentucky
Kentucky Pediatric/Adult Research Inc ( Site 0136) Recruiting
Bardstown, Kentucky, United States, 40004
Contact: Study Coordinator    502-349-1569      
Michael W Simon, MD., Pediatric & Adolescent Medicine ( Site 0276) Recruiting
Nicholasville, Kentucky, United States, 40356
Contact: Study Coordinator    859-277-6516      
United States, Louisiana
ACC Pediatric Research ( Site 0147) Recruiting
Haughton, Louisiana, United States, 71037
Contact: Study Coordinator    318-949-0539      
Medpharmics, LLC ( Site 0157) Recruiting
Metairie, Louisiana, United States, 70006
Contact: Study Coordinator    504-304-7197      
United States, Maryland
Virgo-Carter Pediatrics ( Site 0275) Recruiting
Silver Spring, Maryland, United States, 20910
Contact: Study Coordinator    301-275-5571      
United States, Massachusetts
Tufts Medical Center-Floating Hospital for Children ( Site 0129) Recruiting
Boston, Massachusetts, United States, 02111
Contact: Study Coordinator    617-636-4192      
Pediatric Associates of Fall River ( Site 0183) Recruiting
Fall River, Massachusetts, United States, 02721
Contact: Study Coordinator    401-580-8202      
United States, Mississippi
MediSync Clinical Research Hattiesburg Clinic ( Site 0259) Recruiting
Petal, Mississippi, United States, 39465
Contact: Study Coordinator    601-296-2987      
United States, Missouri
Children's Mercy Clinics on Broadway ( Site 0171) Recruiting
Kansas City, Missouri, United States, 64111
Contact: Study Coordinator    816-760-8845      
United States, Nebraska
Midwest Children's Health Research Institute, LLC ( Site 0109) Recruiting
Lincoln, Nebraska, United States, 68505
Contact: Study Coordinator    402-327-6065      
Midwest Children's Health Research Institute, LLC ( Site 0106) Recruiting
Lincoln, Nebraska, United States, 68522
Contact: Study Coordinator    402-327-6065      
Children's Physicians, UNMC ( Site 0252) Recruiting
Omaha, Nebraska, United States, 68198
Contact: Study Coordinator    402-280-4961      
United States, New Mexico
Southwest CARE Center ( Site 0161) Recruiting
Santa Fe, New Mexico, United States, 87501
Contact: Study Coordinator    505-216-1996      
United States, New York
Advantage Clinical Trials ( Site 0274) Recruiting
Bronx, New York, United States, 10468
Contact: Study Coordinator    917-962-0234      
Child Health Care Associates ( Site 0242) Recruiting
East Syracuse, New York, United States, 13057
Contact: Study Coordinator    315-464-6331      
Child Health Care Associates ( Site 0267) Recruiting
Liverpool, New York, United States, 13090
Contact: Study Coordinator    315-464-6331      
United States, North Carolina
Haywood Pediatric and Adolescent Medicine Group ( Site 0248) Recruiting
Clyde, North Carolina, United States, 28721
Contact: Study Coordinator    828-452-2211      
Capitol Pediatrics & Adolescent Center ( Site 0223) Active, not recruiting
Raleigh, North Carolina, United States, 27609
United States, Ohio
Senders Pediatrics ( Site 0190) Recruiting
Cleveland, Ohio, United States, 44121
Contact: Study Coordinator    216-291-9210      
Dayton Clinical Research ( Site 0188) Recruiting
Dayton, Ohio, United States, 45406
Contact: Study Coordinator    937-276-4311      
United States, Oregon
Cyn3rgy Research ( Site 0246) Recruiting
Gresham, Oregon, United States, 97030
Contact: Study Coordinator    503-907-2179      
United States, Pennsylvania
Allegheny Health & Wellness Pavilion West ( Site 0210) Recruiting
Erie, Pennsylvania, United States, 16506
Contact: Study Coordinator    814-838-8724      
Lockman & Lubell Pediatrics ( Site 0166) Recruiting
Fort Washington, Pennsylvania, United States, 19034
Contact: Study Coordinator    215-964-2862      
CCP- Kid's Way ( Site 0130) Recruiting
Hermitage, Pennsylvania, United States, 16148
Contact: Study Coordinator    724-981-1219      
United States, South Carolina
Palmetto Pediatrics, PA ( Site 0164) Recruiting
Charleston, South Carolina, United States, 29406-9170
Contact: Study Coordinator    843-797-5600      
Cheraw Pediatrics ( Site 0280) Recruiting
Cheraw, South Carolina, United States, 29520
Contact: Study Coordinator    843-537-1811      
Parkside Pediatric ( Site 0125) Recruiting
Greenville, South Carolina, United States, 29607
Contact: Study Coordinator    863-272-0388      
United States, Tennessee
Holston Medical Group ( Site 0165) Recruiting
Kingsport, Tennessee, United States, 37660
Contact: Study Coordinator    423-230-2421      
United States, Texas
DFW Clinical Research ( Site 0111) Recruiting
Dallas, Texas, United States, 75234
Contact: Study Coordinator    469-225-5800      
University of Texas Medical Branch ( Site 0185) Recruiting
Galveston, Texas, United States, 77555
Contact: Study Coordinator    409-772-5278      
Ventavia Research Group LLC ( Site 0142) Recruiting
Houston, Texas, United States, 77008
Contact: Study Coordinator    832-404-1688      
Pediatric Associates ( Site 0209) Recruiting
Houston, Texas, United States, 77087
Contact: Study Coordinator    713-777-5343      
Houston Clinical Research Network ( Site 0266) Recruiting
Houston, Texas, United States, 77090
Contact: Study Coordinator    281-650-1846      
Ventavia Research Group LLC ( Site 0139) Recruiting
Keller, Texas, United States, 76248
Contact: Study Coordinator    682-774-8013      
FMC Science ( Site 0115) Recruiting
Lampasas, Texas, United States, 76550
Contact: Study Coordinator    512-556-4130      
University of Texas Medical Branch ( Site 0170) Recruiting
League City, Texas, United States, 77573
Contact: Study Coordinator    832-340-2310      
DCOL Center for Clinical Research ( Site 0247) Recruiting
Longview, Texas, United States, 75605
Contact: Study Coordinator    903-238-8854      
United States, Utah
Wee Care Pediatrics ( Site 0154) Recruiting
Layton, Utah, United States, 84041
Contact: Study Coordinator    801-773-8644      
Cottonwood Pediatrics ( Site 0153) Recruiting
Murray, Utah, United States, 84107
Contact: Study Coordinator    801-294-9911      
Pediatric Care ( Site 0138) Recruiting
Provo, Utah, United States, 84604
Contact: Study Coordinator    801-377-8000      
Wee Care Pediatrics-Roy ( Site 0174) Recruiting
Roy, Utah, United States, 84067
Contact: Study Coordinator    801-773-8644      
Dixie Pediatrics ( Site 0260) Recruiting
Saint George, Utah, United States, 84790
Contact: Study Coordinator    435-628-8232      
Wee Care Pediatrics ( Site 0193) Recruiting
Syracuse, Utah, United States, 84075
Contact: Study Coordinator    801-773-8644      
United States, Washington
MultiCare Rockwood Cheney Clinic ( Site 0195) Recruiting
Cheney, Washington, United States, 99004
Contact: Study Coordinator    509-342-3429      
Multicare / Rockwood Clinic ( Site 0167) Recruiting
Spokane, Washington, United States, 99202
Contact: Study Coordinator    509-342-3773      
Puerto Rico
Cooperativa de Facultad Medica Sanacoop ( Site 0077) Recruiting
Bayamon, Puerto Rico, 00961
Contact: Study Coordinator    7877809196      
Clinical Research of Puerto Rico ( Site 0075) Recruiting
Guayama, Puerto Rico, 00784
Contact: Study Coordinator    7877235945      
CAIMED Center - Ponce School of Medicine ( Site 0076) Recruiting
Ponce, Puerto Rico, 00716
Contact: Study Coordinator    7878402505      
San Juan Hospital ( Site 0079) Recruiting
San Juan, Puerto Rico, 00935
Contact: Study Coordinator    7877643083      
University of Puerto Rico - Medical Science Campus ( Site 0078) Recruiting
San Juan, Puerto Rico, 00935
Contact: Study Coordinator    7876450397      
Elba Antoniette Perez Vargas MD-Private Practice ( Site 0081) Recruiting
Trujillo Alto, Puerto Rico, 00976
Contact: Study Coordinator    +7877487120      
Thailand
Khon Kaen University ( Site 0031) Active, not recruiting
Muang, Khon Kaen, Thailand, 40002
Phramongkutklao Hospital ( Site 0033) Recruiting
Bangkok, Thailand, 10400
Contact: Study Coordinator    +66897988361      
Siriraj Hospital ( Site 0032) Recruiting
Bangkok, Thailand, 10700
Contact: Study Coordinator    +6624180545      
Maharaj Nakorn Chiang Mai Hospital ( Site 0030) Recruiting
Chiang Mai, Thailand, 50200
Contact: Study Coordinator    +66891927004      
Turkey
Cukurova Uni Tip Fak Cocuk Saglıgı ve Hasta ABD ( Site 0060) Recruiting
Adana, Turkey, 01330
Contact: Study Coordinator    +905323826869      
Ankara Universitesi Tip Fakultesi ( Site 0053) Recruiting
Ankara, Turkey, 06590
Contact: Study Coordinator    +903125957291      
Ege University Medical Faculty Hospital ( Site 0050) Recruiting
Izmir, Turkey, 35040
Contact: Study Coordinator    +905372501536      
Dokuz Eylul University Faculty of Medicine ( Site 0054) Recruiting
Izmir, Turkey, 35340
Contact: Study Coordinator    +905053190158      
Erciyes Universitesi Tip Fakultesi ( Site 0057) Recruiting
Kayseri, Turkey, 38039
Contact: Study Coordinator    +905057011878      
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: NCT03893448     History of Changes
Other Study ID Numbers: V114-029
V114-029 ( Other Identifier: Merck )
2018-004109-21 ( EudraCT Number )
First Posted: March 28, 2019    Key Record Dates
Last Update Posted: December 6, 2019
Last Verified: December 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