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

Primary Purpose

Pneumococcal Infections, Pneumococcal Vaccines

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
V114
Prevnar 13™
RotaTeq™
Pentacel™
RECOMBIVAX HB™
VAQTA™
MMR II™
VARIVAX™
HIBERIX™
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumococcal Infections

Eligibility Criteria

42 Days - 90 Days (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Alabama Clinical Therapeutics ( Site 0159)
  • Southeastern Pediatric Associates, P.A. ( Site 0107)
  • South Alabama Pediatrics ( Site 0263)
  • Northwest Arkansas Pediatric Clinic ( Site 0172)
  • Children's Clinic of Jonesboro, PA ( Site 0184)
  • Advanced Clinical Research - Rancho Paseo ( Site 0163)
  • Altissima Clinical Research LLC ( Site 0213)
  • Southland Clinical Research Center ( Site 0187)
  • Premier Health Research Center, LLC ( Site 0121)
  • Kaiser Permanente Vaccine Study Center - Oakland ( Site 0282)
  • Kaiser Permanente - Sacramento ( Site 0257)
  • Kaiser Permanente Vaccine Study Center - South Sacramento ( Site 0256)
  • Kaiser Permanente - San Jose ( Site 0258)
  • Kaiser Permanente - Santa Clara ( Site 0244)
  • Davita Medical Group ( Site 0141)
  • Suncoast Research Associates, LLC ( Site 0250)
  • Suncoast Research Associates, LLC ( Site 0249)
  • Children's Health Center ( Site 0272)
  • Saltzer Medical Group ( Site 0215)
  • Kentucky Pediatric/Adult Research Inc ( Site 0136)
  • Michael W Simon, MD., Pediatric & Adolescent Medicine ( Site 0276)
  • ACC Pediatric Research ( Site 0147)
  • Medpharmics, LLC ( Site 0157)
  • Virgo-Carter Pediatrics ( Site 0275)
  • Tufts Medical Center-Floating Hospital for Children ( Site 0129)
  • Pediatric Associates of Fall River ( Site 0183)
  • MediSync Clinical Research Hattiesburg Clinic ( Site 0259)
  • Children's Mercy Clinics on Broadway ( Site 0171)
  • Midwest Children's Health Research Institute, LLC ( Site 0109)
  • Midwest Children's Health Research Institute, LLC ( Site 0106)
  • Children's Physicians, UNMC ( Site 0252)
  • Southwest CARE Center ( Site 0161)
  • Advantage Clinical Trials ( Site 0274)
  • Child Health Care Associates ( Site 0242)
  • Child Health Care Associates ( Site 0267)
  • Haywood Pediatric and Adolescent Medicine Group ( Site 0248)
  • Capitol Pediatrics & Adolescent Center ( Site 0223)
  • Senders Pediatrics ( Site 0190)
  • Dayton Clinical Research ( Site 0188)
  • Cyn3rgy Research ( Site 0246)
  • Pediatric Medical Associates ( Site 0239)
  • Allegheny Health & Wellness Pavilion West ( Site 0210)
  • Lockman & Lubell Pediatrics ( Site 0166)
  • CCP- Kid's Way ( Site 0130)
  • Palmetto Pediatrics, PA ( Site 0164)
  • Cheraw Pediatrics ( Site 0280)
  • Parkside Pediatric ( Site 0125)
  • Holston Medical Group ( Site 0165)
  • DFW Clinical Research ( Site 0111)
  • University of Texas Medical Branch ( Site 0185)
  • Ventavia Research Group LLC ( Site 0142)
  • Pediatric Associates ( Site 0209)
  • Houston Clinical Research Network ( Site 0266)
  • Ventavia Research Group LLC ( Site 0139)
  • FMC Science ( Site 0115)
  • University of Texas Medical Branch ( Site 0170)
  • DCOL Center for Clinical Research ( Site 0247)
  • Wee Care Pediatrics ( Site 0154)
  • Cottonwood Pediatrics ( Site 0153)
  • Pediatric Care ( Site 0138)
  • Wee Care Pediatrics-Roy ( Site 0174)
  • Dixie Pediatrics ( Site 0260)
  • University of Utah ( Site 0214)
  • Wee Care Pediatrics ( Site 0193)
  • MultiCare Rockwood Cheney Clinic ( Site 0195)
  • Multicare / Rockwood Clinic ( Site 0167)
  • Cooperativa de Facultad Medica Sanacoop ( Site 0077)
  • Clinical Research of Puerto Rico ( Site 0075)
  • CAIMED Center - Ponce School of Medicine ( Site 0076)
  • San Juan Hospital ( Site 0079)
  • University of Puerto Rico - Medical Science Campus ( Site 0078)
  • Elba Antoniette Perez Vargas MD-Private Practice ( Site 0081)
  • Khon Kaen University ( Site 0031)
  • Phramongkutklao Hospital ( Site 0033)
  • Siriraj Hospital ( Site 0032)
  • Maharaj Nakorn Chiang Mai Hospital ( Site 0030)
  • Cukurova Uni Tip Fak Cocuk Saglıgı ve Hasta ABD ( Site 0060)
  • Ankara Universitesi Tip Fakultesi ( Site 0053)
  • Ege University Medical Faculty Hospital ( Site 0050)
  • Dokuz Eylul University Faculty of Medicine ( Site 0054)
  • Erciyes Universitesi Tip Fakultesi ( Site 0057)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

V114

Prevnar 13™

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) in V114 Versus 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
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)
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
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
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
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
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
Pertussis antibody GMCs were measured using Luminex Assay.
Hepatitis A Antibody Response Rate One Month After Vaccination 4
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
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
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
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
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
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
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
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
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
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
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
Serotype 3-specific anti-PnP GMC were measured with PnECL.

Full Information

First Posted
March 26, 2019
Last Updated
July 20, 2023
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03893448
Brief Title
Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-029)
Acronym
PNEU-PED
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 19, 2019 (Actual)
Primary Completion Date
May 24, 2021 (Actual)
Study Completion Date
May 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumococcal Infections, Pneumococcal Vaccines

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
1720 (Actual)

8. Arms, Groups, and Interventions

Arm Title
V114
Arm Type
Experimental
Arm Description
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.
Arm Title
Prevnar 13™
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
V114
Other Intervention Name(s)
VAXNEUVANCE™, Pneumococcal 15-Valent Conjugate Vaccine
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Prevnar 13™
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
RotaTeq™
Intervention Description
A total of 3 RotaTeq™ 2 mL oral dosings at ~2, ~4, and ~6 months of age.
Intervention Type
Biological
Intervention Name(s)
Pentacel™
Intervention Description
A total of 3 Pentacel™ 0.5 mL IM dosings at ~2, ~4, and ~6 months of age.
Intervention Type
Biological
Intervention Name(s)
RECOMBIVAX HB™
Intervention Description
A total of 3 RECOMBIVAX HB™ 0.5 mL IM dosings at ~2, ~4, and ~6 months of age.
Intervention Type
Biological
Intervention Name(s)
VAQTA™
Intervention Description
One VAQTA™ 0.5 mL IM dosing at 12 to 15 months of age.
Intervention Type
Biological
Intervention Name(s)
MMR II™
Intervention Description
One MMR II™ 0.5 mL subcutaneous (SC) dosing at 12 to 15 months of age.
Intervention Type
Biological
Intervention Name(s)
VARIVAX™
Intervention Description
One VARIVAX™ 0.5 mL SC dosing at 12 to 15 months of age.
Intervention Type
Biological
Intervention Name(s)
HIBERIX™
Intervention Description
One HIBERIX™ 0.5 mL IM dosing at Visit 5.
Primary Outcome Measure Information:
Title
Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) in V114 Versus Prevnar 13™
Description
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.
Time Frame
Up to 14 days after each vaccination with either V114 or Prevnar 13™
Title
Percentage of Participants With Solicited Systemic AEs
Description
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.
Time Frame
Up to 14 days after each vaccination with either V114 or Prevnar 13™
Title
Percentage of Participants With Vaccine-Related Serious Adverse Events (SAEs)
Description
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.
Time Frame
From Day 1 up to 6 months after Vaccination 4 (up to 21 months)
Title
Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3
Description
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.
Time Frame
One month after Vaccination 3 (Month 7)
Title
Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3
Description
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.
Time Frame
One month after Vaccination 3 (Month 7)
Title
GMC of Anti-PnP IgG Ab One Month After Vaccination 4
Description
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.
Time Frame
One month after Vaccination 4 (Month 13 to Month 16)
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
One month after Vaccination 3 (Month 7)
Title
Pertussis Antigen Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3
Description
Pertussis antibody GMCs were measured using Luminex Assay.
Time Frame
One month after Vaccination 3 (Month 7)
Title
Hepatitis A Antibody Response Rate One Month After Vaccination 4
Description
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.
Time Frame
One month after Vaccination 4 (Month 13 to Month 16)
Title
Measles, Mumps, and Rubella Antibody Response Rate One Month After Vaccination 4
Description
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.
Time Frame
One month after Vaccination 4 (Month 13 to Month 16)
Title
Varicella-Zoster Virus (VZV) Antibody Response Rate One Month After Vaccination 4
Description
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.
Time Frame
One month after Vaccination 4 (Month 13 to Month 16)
Title
Haemophilus Influenzae Type B Antibody Response Rate One Month After Vaccination 4
Description
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.
Time Frame
One month after Vaccination 4 (Month 13 to Month 16)
Title
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 3 for 2 Unique V114 Seroptypes
Description
Serotype-specific anti-PnP IgG GMCs for the 2 unique V114 serotypes were measured with PnECL. The GMCs for each serotype are reported.
Time Frame
One month after Vaccination 3 (Month 7)
Title
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Response Rates One Month After Vaccination 3 for 2 Unique V114 Seroptypes
Description
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.
Time Frame
One month after Vaccination 3 (Month 7)
Title
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMC) One Month After Vaccination 4 for 2 Unique V114 Seroptypes
Description
Serotype-specific anti-PnP GMCs were measured with PnECL. The GMC for each serotype is reported.
Time Frame
One month after Vaccination 4 (Month 13 to Month 16)
Title
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3
Description
Serotype-specific anti-PnP OPA GMTs were measured with multiplex opsonophagocytic assay (MOPA). The GMTs for each serotype are summarized.
Time Frame
One month after Vaccination 3 (Month 7)
Title
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3
Description
Serotype-specific anti-PnP OPA GMTs were measured with MOPA. The percentage of participants meeting ≥0.35 ug/mL are reported for each serotype.
Time Frame
One month after Vaccination 3 (Month 7)
Title
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype 3-Specific Immunoglobulin G (IgG) Response Rate One Month After Vaccination 3
Description
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.
Time Frame
One month after Vaccination 3 (Month 7)
Title
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype 3-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 3
Description
Serotype 3-specific anti-PnP GMC was measured with PnECL.
Time Frame
One month after Vaccination 3 (Month 7)
Title
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype 3-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 4
Description
Serotype 3-specific anti-PnP GMC were measured with PnECL.
Time Frame
One month after Vaccination 4 (Month 13 to Month 16)

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
36621410
Citation
Lupinacci R, Rupp R, Wittawatmongkol O, Jones J, Quinones J, Ulukol B, Dagan R, Richmond P, Stek JE, Romero L, Koseoglu S, Tamms G, McFetridge R, Li J, Cheon K, Musey L, Banniettis N, Bickham K; V114-029 PNEU-PED study group. 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, a 15-valent pneumococcal conjugate vaccine, in healthy infants (PNEU-PED). Vaccine. 2023 Jan 27;41(5):1142-1152. doi: 10.1016/j.vaccine.2022.12.054. Epub 2023 Jan 6.
Results Reference
result

Learn more about this trial

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

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