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. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT03893448

Recruitment Status : Completed

First Posted : March 28, 2019

Results First Posted : March 25, 2022

Last Update Posted : March 25, 2022

Sponsor:

Information provided by (Responsible Party):

Merck Sharp & Dohme LLC

Study Description

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 non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on the response rate of the 2 unique V114 serotypes compared with the lowest response rate of any of the shared serotypes in Prevnar 13™, excluding serotype 3, at 30 days following Dose 3; 3) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes based on anti-pneumococcal polysaccharide (PnPs) serotype-specific immunoglobulin g (IgG) geometric mean concentrations (GMCs) at 30 days following Dose 3; 4) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on the anti-PnPs serotype-specific IgG GMCs of the 2 unique V114 serotypes compared with the lowest IgG GMC of any of the shared serotypes in Prevnar 13™, excluding serotype 3, at 30 days following Dose 3; 5) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes between V114 and Prevnar 13™ based on anti-PnPs serotype-specific IgG GMCs at 30 days following Dose 4; and 6) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on anti-PnPs serotype-specific IgG GMCs of the 2 unique V114 serotypes compared with the lowest IgG GMC of any of the shared serotypes in Prevnar 13, excluding serotype 3, at 30 days following Dose 4.

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: MMR II™ Biological: VARIVAX™ Biological: HIBERIX™	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual 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
Actual Primary Completion Date :	May 24, 2021
Actual Study Completion Date :	May 24, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

U.S. FDA Resources

Arms and Interventions

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. Other Names: VAXNEUVANCE™ Pneumococcal 15-Valent Conjugate Vaccine 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: MMR II™ One MMR II™ 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: MMR II™ One MMR II™ 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.

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.

Other Names:

VAXNEUVANCE™
Pneumococcal 15-Valent Conjugate Vaccine

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: MMR II™

One MMR II™ 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: MMR II™

One MMR II™ 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.

Outcome Measures

Primary Outcome Measures :

Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) in V114 Versus Prevnar 13™ [ Time Frame: Up to 14 days after each vaccination with either V114 or Prevnar 13™ ]
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 consisted of swelling, redness, pain or tenderness, and hard lump.
Percentage of Participants With Solicited Systemic AEs [ Time Frame: Up to 14 days after each vaccination with either V114 or Prevnar 13™ ]
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 consisted of irritability, drowsiness, appetite lost, and hives or welts.
Percentage of Participants With Vaccine-Related Serious Adverse Events (SAEs) [ Time Frame: From Day 1 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 are summarized.
Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3 [ Time Frame: One month after Vaccination 3 (Month 7) ]
Anti-PnP serotype-specific IgG response rates for the 15 serotypes contained in V114 were measured with pneumococcal electrochemiluminescence (PnECL). The percentage of participants with IgG Ab ≥0.35 ug/mL are reported for each serotype.
Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3 [ Time Frame: One month after Vaccination 3 (Month 7) ]
The GMC of anti-PnP IgG Ab were measured with PnECL one month after vaccination 3 and reported for the 15 serotypes contained in V114. IgG GMCs were compared to the lowest in recipients of Prevnar 13™ excluding serotype 3 for the 2 serotypes unique to V114, and compared to the same serotypes for the 13 shared serotypes.
GMC of Anti-PnP IgG Ab One Month After Vaccination 4 [ Time Frame: One month after Vaccination 4 (Month 13 to Month 16) ]
The GMC of anti-PnP IgG Ab were measured with PnECL one month after vaccination 4 and reported for the 15 serotypes contained in V114. IgG GMCs were compared to the lowest in recipients of Prevnar 13™ excluding serotype 3 for the 2 serotypes unique to V114, and compared to the same serotypes for the 13 shared serotypes.

Secondary Outcome Measures :

Percentage of Participants Meeting Response Rate Criteria for Pentacel™-Specific (Anti-Diptheria Toxoid, Tetanus Toxoid, and Pertussis Antigens) Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3 [ Time Frame: One month after Vaccination 3 (Month 7) ]
Antibody responses to diphtheria toxoid, tetanus toxoid, and pertussis antigens were measured using Luminex Assay. The percentage of participants meeting specific criteria are 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: % neutralizing antibody (NAb) ≥1:8 dilution; poliovirus 2: % NAb ≥1:8 dilution, poliovirus 3: % NAb ≥1:8 dilution; and Haemophilus influenzae Type B polyribosylribitol phosphate (Hib-PRP): % ≥0.15 ug/mL.
Pertussis Antigen Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3 [ Time Frame: One month after Vaccination 3 (Month 7) ]
Pertussis antibody GMCs were measured using Luminex Assay.
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 were measured with hepatitis A virus enzyme immunoassay (HAV EIA). The percentage of participants with hepatitis A antigen ≥10 mIU/mL are reported.
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 were measured with the bulk measles IgG enzyme immunoassay (EIA). Antibody responses to mumps were measured with enzyme-linked immunosorbent assay (ELISA). Antibody responses to rubella were 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, are reported.
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 were measured with glycoprotein enzyme-linked immunosorbent assay (gpELISA). The percentage of participants with VZV antigen ≥5 gpELISA units/mL are reported.
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) were measured with ELISA. The percentage of participants with anti-HiB PRP antigen ≥0.15 ug/mL are reported.
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 3 for 2 Unique V114 Seroptypes [ Time Frame: One month after Vaccination 3 (Month 7) ]
Serotype-specific anti-PnP IgG GMCs for the 2 unique V114 serotypes were measured with PnECL. The GMCs for each serotype are reported.
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Response Rates One Month After Vaccination 3 for 2 Unique V114 Seroptypes [ Time Frame: One month after Vaccination 3 (Month 7) ]
Serotype-specific anti-PnP IgG response rates for the 2 unique V114 serotypes were measured with PnECL. The percentage of participants with IgG Ab ≥0.35 ug/mL are reported for each serotype.
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMC) One Month After Vaccination 4 for 2 Unique V114 Seroptypes [ Time Frame: One month after Vaccination 4 (Month 13 to Month 16) ]
Serotype-specific anti-PnP GMCs were measured with PnECL. The GMC for each serotype is reported.
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3 [ Time Frame: One month after Vaccination 3 (Month 7) ]
Serotype-specific anti-PnP OPA GMTs were measured with multiplex opsonophagocytic assay (MOPA). The GMTs for each serotype are summarized.
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 were measured with MOPA. The percentage of participants meeting ≥0.35 ug/mL are reported for each serotype.
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype 3-Specific Immunoglobulin G (IgG) Response Rate One Month After Vaccination 3 [ Time Frame: One month after Vaccination 3 (Month 7) ]
Serotype 3-specific anti-PnP IgG response rates were measured with PnECL. The percentage of participants with IgG Ab ≥0.35 ug/mL are reported for Serotype 3.
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype 3-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 3 [ Time Frame: One month after Vaccination 3 (Month 7) ]
Serotype 3-specific anti-PnP GMC was measured with PnECL.
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype 3-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 4 [ Time Frame: One month after Vaccination 4 (Month 13 to Month 16) ]
Serotype 3-specific anti-PnP GMC were measured with PnECL.

Eligibility Criteria

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 Days (Child)
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.

Contacts and Locations

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

Locations

Show 81 study locations

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United States, Alabama
Alabama Clinical Therapeutics ( Site 0159)
Birmingham, Alabama, United States, 35205
Southeastern Pediatric Associates, P.A. ( Site 0107)
Dothan, Alabama, United States, 36305
South Alabama Pediatrics ( Site 0263)
Opp, Alabama, United States, 36467
United States, Arkansas
Northwest Arkansas Pediatric Clinic ( Site 0172)
Fayetteville, Arkansas, United States, 72703
Children's Clinic of Jonesboro, PA ( Site 0184)
Jonesboro, Arkansas, United States, 72401
United States, California
Advanced Clinical Research - Rancho Paseo ( Site 0163)
Banning, California, United States, 92220
Altissima Clinical Research LLC ( Site 0213)
Bellflower, California, United States, 90706
Southland Clinical Research Center ( Site 0187)
Bellflower, California, United States, 90706
Premier Health Research Center, LLC ( Site 0121)
Downey, California, United States, 90240
Kaiser Permanente Vaccine Study Center - Oakland ( Site 0282)
Oakland, California, United States, 94612
Kaiser Permanente - Sacramento ( Site 0257)
Sacramento, California, United States, 95815
Kaiser Permanente Vaccine Study Center - South Sacramento ( Site 0256)
Sacramento, California, United States, 95823
Kaiser Permanente - San Jose ( Site 0258)
San Jose, California, United States, 95119
Kaiser Permanente - Santa Clara ( Site 0244)
Santa Clara, California, United States, 95051
United States, Colorado
Davita Medical Group ( Site 0141)
Colorado Springs, Colorado, United States, 80922
United States, Florida
Suncoast Research Associates, LLC ( Site 0250)
Miami, Florida, United States, 33184
Suncoast Research Associates, LLC ( Site 0249)
North Miami Beach, Florida, United States, 33160
Children's Health Center ( Site 0272)
Tampa, Florida, United States, 33617
United States, Idaho
Saltzer Medical Group ( Site 0215)
Nampa, Idaho, United States, 83686
United States, Kentucky
Kentucky Pediatric/Adult Research Inc ( Site 0136)
Bardstown, Kentucky, United States, 40004
Michael W Simon, MD., Pediatric & Adolescent Medicine ( Site 0276)
Nicholasville, Kentucky, United States, 40356
United States, Louisiana
ACC Pediatric Research ( Site 0147)
Haughton, Louisiana, United States, 71037
Medpharmics, LLC ( Site 0157)
Metairie, Louisiana, United States, 70006
United States, Maryland
Virgo-Carter Pediatrics ( Site 0275)
Silver Spring, Maryland, United States, 20910
United States, Massachusetts
Tufts Medical Center-Floating Hospital for Children ( Site 0129)
Boston, Massachusetts, United States, 02111
Pediatric Associates of Fall River ( Site 0183)
Fall River, Massachusetts, United States, 02721
United States, Mississippi
MediSync Clinical Research Hattiesburg Clinic ( Site 0259)
Petal, Mississippi, United States, 39465
United States, Missouri
Children's Mercy Clinics on Broadway ( Site 0171)
Kansas City, Missouri, United States, 64111
United States, Nebraska
Midwest Children's Health Research Institute, LLC ( Site 0109)
Lincoln, Nebraska, United States, 68505
Midwest Children's Health Research Institute, LLC ( Site 0106)
Lincoln, Nebraska, United States, 68522
Children's Physicians, UNMC ( Site 0252)
Omaha, Nebraska, United States, 68198
United States, New Mexico
Southwest CARE Center ( Site 0161)
Santa Fe, New Mexico, United States, 87501
United States, New York
Advantage Clinical Trials ( Site 0274)
Bronx, New York, United States, 10468
Child Health Care Associates ( Site 0242)
East Syracuse, New York, United States, 13057
Child Health Care Associates ( Site 0267)
Liverpool, New York, United States, 13090
United States, North Carolina
Haywood Pediatric and Adolescent Medicine Group ( Site 0248)
Clyde, North Carolina, United States, 28721
Capitol Pediatrics & Adolescent Center ( Site 0223)
Raleigh, North Carolina, United States, 27609
United States, Ohio
Senders Pediatrics ( Site 0190)
Cleveland, Ohio, United States, 44121
Dayton Clinical Research ( Site 0188)
Dayton, Ohio, United States, 45406
United States, Oregon
Cyn3rgy Research ( Site 0246)
Gresham, Oregon, United States, 97030
United States, Pennsylvania
Pediatric Medical Associates ( Site 0239)
East Norriton, Pennsylvania, United States, 19401
Allegheny Health & Wellness Pavilion West ( Site 0210)
Erie, Pennsylvania, United States, 16506
Lockman & Lubell Pediatrics ( Site 0166)
Fort Washington, Pennsylvania, United States, 19034
CCP- Kid's Way ( Site 0130)
Hermitage, Pennsylvania, United States, 16148
United States, South Carolina
Palmetto Pediatrics, PA ( Site 0164)
Charleston, South Carolina, United States, 29406-9170
Cheraw Pediatrics ( Site 0280)
Cheraw, South Carolina, United States, 29520
Parkside Pediatric ( Site 0125)
Greenville, South Carolina, United States, 29607
United States, Tennessee
Holston Medical Group ( Site 0165)
Kingsport, Tennessee, United States, 37660
United States, Texas
DFW Clinical Research ( Site 0111)
Dallas, Texas, United States, 75234
University of Texas Medical Branch ( Site 0185)
Galveston, Texas, United States, 77555
Ventavia Research Group LLC ( Site 0142)
Houston, Texas, United States, 77008
Pediatric Associates ( Site 0209)
Houston, Texas, United States, 77087
Houston Clinical Research Network ( Site 0266)
Houston, Texas, United States, 77090
Ventavia Research Group LLC ( Site 0139)
Keller, Texas, United States, 76248
FMC Science ( Site 0115)
Lampasas, Texas, United States, 76550
University of Texas Medical Branch ( Site 0170)
League City, Texas, United States, 77573
DCOL Center for Clinical Research ( Site 0247)
Longview, Texas, United States, 75605
United States, Utah
Wee Care Pediatrics ( Site 0154)
Layton, Utah, United States, 84041
Cottonwood Pediatrics ( Site 0153)
Murray, Utah, United States, 84107
Pediatric Care ( Site 0138)
Provo, Utah, United States, 84604
Wee Care Pediatrics-Roy ( Site 0174)
Roy, Utah, United States, 84067
Dixie Pediatrics ( Site 0260)
Saint George, Utah, United States, 84790
University of Utah ( Site 0214)
Salt Lake City, Utah, United States, 84113
Wee Care Pediatrics ( Site 0193)
Syracuse, Utah, United States, 84075
United States, Washington
MultiCare Rockwood Cheney Clinic ( Site 0195)
Cheney, Washington, United States, 99004
Multicare / Rockwood Clinic ( Site 0167)
Spokane, Washington, United States, 99202
Puerto Rico
Cooperativa de Facultad Medica Sanacoop ( Site 0077)
Bayamon, Puerto Rico, 00961
Clinical Research of Puerto Rico ( Site 0075)
Guayama, Puerto Rico, 00784
CAIMED Center - Ponce School of Medicine ( Site 0076)
Ponce, Puerto Rico, 00716
San Juan Hospital ( Site 0079)
San Juan, Puerto Rico, 00935
University of Puerto Rico - Medical Science Campus ( Site 0078)
San Juan, Puerto Rico, 00935
Elba Antoniette Perez Vargas MD-Private Practice ( Site 0081)
Trujillo Alto, Puerto Rico, 00976
Thailand
Khon Kaen University ( Site 0031)
Muang, Khon Kaen, Thailand, 40002
Phramongkutklao Hospital ( Site 0033)
Bangkok, Thailand, 10400
Siriraj Hospital ( Site 0032)
Bangkok, Thailand, 10700
Maharaj Nakorn Chiang Mai Hospital ( Site 0030)
Chiang Mai, Thailand, 50200
Turkey
Cukurova Uni Tip Fak Cocuk Saglıgı ve Hasta ABD ( Site 0060)
Adana, Turkey, 01330
Ankara Universitesi Tip Fakultesi ( Site 0053)
Ankara, Turkey, 06590
Ege University Medical Faculty Hospital ( Site 0050)
Izmir, Turkey, 35040
Dokuz Eylul University Faculty of Medicine ( Site 0054)
Izmir, Turkey, 35340
Erciyes Universitesi Tip Fakultesi ( Site 0057)
Kayseri, Turkey, 38039

Sponsors and Collaborators

Merck Sharp & Dohme LLC

Investigators

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Study Director:	Medical Director	Merck Sharp & Dohme LLC

Study Documents (Full-Text)

Documents provided by Merck Sharp & Dohme LLC:

Study Protocol and Statistical Analysis Plan [PDF] March 16, 2021

More Information

Publications of Results:

Buchwald UK, Andrews CP, Ervin J, Peterson JT, Tamms GM, Krupa D, Ajiboye P, Roalfe L, Krick AL, Sterling TM, Wang M, Martin JC, Stek JE, Kohn MA, Folaranmi T, Abeygunawardana C, Hartzel J, Musey LK; V110-029 Study Group. Sequential administration of Prevnar 13™ and PNEUMOVAX™ 23 in healthy participants 50 years of age and older. Hum Vaccin Immunother. 2021 Aug 3;17(8):2678-2690. doi: 10.1080/21645515.2021.1888621. Epub 2021 May 21.

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Responsible Party:	Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier:	NCT03893448
Other Study ID Numbers:	V114-029 V114-029 ( Other Identifier: Merck ) 2018-004109-21 ( EudraCT Number )
First Posted:	March 28, 2019 Key Record Dates
Results First Posted:	March 25, 2022
Last Update Posted:	March 25, 2022
Last Verified:	February 2022
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 Bacterial Infections and Mycoses	Infections Heptavalent Pneumococcal Conjugate Vaccine Immunologic Factors Physiological Effects of Drugs

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