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

July 20, 2023 updated by: Merck Sharp & Dohme LLC

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1720

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 3 years (Child)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 14 days after each vaccination with either V114 or Prevnar 13™
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.
Up to 14 days after each vaccination with either V114 or Prevnar 13™
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.
From Day 1 up to 6 months after Vaccination 4 (up to 21 months)
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.
One month after Vaccination 3 (Month 7)
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.
One month after Vaccination 3 (Month 7)
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.
One month after Vaccination 4 (Month 13 to Month 16)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One month after Vaccination 3 (Month 7)
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.
One month after Vaccination 3 (Month 7)
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.
One month after Vaccination 4 (Month 13 to Month 16)
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.
One month after Vaccination 4 (Month 13 to Month 16)
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.
One month after Vaccination 4 (Month 13 to Month 16)
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.
One month after Vaccination 4 (Month 13 to Month 16)
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.
One month after Vaccination 3 (Month 7)
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.
One month after Vaccination 3 (Month 7)
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.
One month after Vaccination 4 (Month 13 to Month 16)
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.
One month after Vaccination 3 (Month 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 were measured with MOPA. The percentage of participants meeting ≥0.35 ug/mL are reported for each serotype.
One month after Vaccination 3 (Month 7)
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.
One month after Vaccination 3 (Month 7)
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.
One month after Vaccination 3 (Month 7)
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.
One month after Vaccination 4 (Month 13 to Month 16)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2019

Primary Completion (Actual)

May 24, 2021

Study Completion (Actual)

May 24, 2021

Study Registration Dates

First Submitted

March 26, 2019

First Submitted That Met QC Criteria

March 26, 2019

First Posted (Actual)

March 28, 2019

Study Record Updates

Last Update Posted (Actual)

July 28, 2023

Last Update Submitted That Met QC Criteria

July 20, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V114-029 (Other Identifier: Merck)
  • 2018-004109-21 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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