Clinical trial NCT03893448: Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-029)
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumococcal Infections
Pneumococcal Vaccines
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2019-03-28
Enrollment: 1720
Sex: ALL
Minimum age (years): 42
Maximum age (years): 90
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) in V114 Versus Prevnar 13™
timeFrame: Up to 14 days after each vaccination with either V114 or Prevnar 13™
measure: Percentage of Participants With Solicited Systemic AEs
timeFrame: Up to 14 days after each vaccination with either V114 or Prevnar 13™
measure: Percentage of Participants With Vaccine-Related Serious Adverse Events (SAEs)
timeFrame: From Day 1 up to 6 months after Vaccination 4 (up to 21 months)
measure: Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3
timeFrame: One month after Vaccination 3 (Month 7)
measure: Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3
timeFrame: One month after Vaccination 3 (Month 7)
measure: GMC of Anti-PnP IgG Ab One Month After Vaccination 4
timeFrame: One month after Vaccination 4 (Month 13 to Month 16)
Secondary outcomes:
measure: 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
timeFrame: One month after Vaccination 3 (Month 7)
measure: Pertussis Antigen Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3
timeFrame: One month after Vaccination 3 (Month 7)
measure: Hepatitis A Antibody Response Rate One Month After Vaccination 4
timeFrame: One month after Vaccination 4 (Month 13 to Month 16)
measure: Measles, Mumps, and Rubella Antibody Response Rate One Month After Vaccination 4
timeFrame: One month after Vaccination 4 (Month 13 to Month 16)
measure: Varicella-Zoster Virus (VZV) Antibody Response Rate One Month After Vaccination 4
timeFrame: One month after Vaccination 4 (Month 13 to Month 16)
measure: Haemophilus Influenzae Type B Antibody Response Rate One Month After Vaccination 4
timeFrame: One month after Vaccination 4 (Month 13 to Month 16)
measure: Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 3 for 2 Unique V114 Seroptypes
timeFrame: One month after Vaccination 3 (Month 7)
measure: Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Response Rates One Month After Vaccination 3 for 2 Unique V114 Seroptypes
timeFrame: One month after Vaccination 3 (Month 7)
measure: Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMC) One Month After Vaccination 4 for 2 Unique V114 Seroptypes
timeFrame: One month after Vaccination 4 (Month 13 to Month 16)
measure: Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3
timeFrame: One month after Vaccination 3 (Month 7)
measure: Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3
timeFrame: One month after Vaccination 3 (Month 7)
measure: Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype 3-Specific Immunoglobulin G (IgG) Response Rate One Month After Vaccination 3
timeFrame: One month after Vaccination 3 (Month 7)
measure: Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype 3-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 3
timeFrame: One month after Vaccination 3 (Month 7)
measure: Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype 3-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 4
timeFrame: One month after Vaccination 4 (Month 13 to Month 16)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics ( Site 0159)
state: Alabama
city: Dothan
country: United States
facility: Southeastern Pediatric Associates, P.A. ( Site 0107)
state: Alabama
city: Opp
country: United States
facility: South Alabama Pediatrics ( Site 0263)
state: Alabama
city: Fayetteville
country: United States
facility: Northwest Arkansas Pediatric Clinic ( Site 0172)
state: Arkansas
city: Jonesboro
country: United States
facility: Children's Clinic of Jonesboro, PA ( Site 0184)
state: Arkansas
city: Banning
country: United States
facility: Advanced Clinical Research - Rancho Paseo ( Site 0163)
state: California
city: Bellflower
country: United States
facility: Altissima Clinical Research LLC ( Site 0213)
state: California
city: Bellflower
country: United States
facility: Southland Clinical Research Center ( Site 0187)
state: California
city: Downey
country: United States
facility: Premier Health Research Center, LLC ( Site 0121)
state: California
city: Oakland
country: United States
facility: Kaiser Permanente Vaccine Study Center - Oakland ( Site 0282)
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente - Sacramento ( Site 0257)
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente Vaccine Study Center - South Sacramento ( Site 0256)
state: California
city: San Jose
country: United States
facility: Kaiser Permanente - San Jose ( Site 0258)
state: California
city: Santa Clara
country: United States
facility: Kaiser Permanente - Santa Clara ( Site 0244)
state: California
city: Colorado Springs
country: United States
facility: Davita Medical Group ( Site 0141)
state: Colorado
city: Miami
country: United States
facility: Suncoast Research Associates, LLC ( Site 0250)
state: Florida
city: North Miami Beach
country: United States
facility: Suncoast Research Associates, LLC ( Site 0249)
state: Florida
city: Tampa
country: United States
facility: Children's Health Center ( Site 0272)
state: Florida
city: Nampa
country: United States
facility: Saltzer Medical Group ( Site 0215)
state: Idaho
city: Bardstown
country: United States
facility: Kentucky Pediatric/Adult Research Inc ( Site 0136)
state: Kentucky
city: Nicholasville
country: United States
facility: Michael W Simon, MD., Pediatric & Adolescent Medicine ( Site 0276)
state: Kentucky
city: Haughton
country: United States
facility: ACC Pediatric Research ( Site 0147)
state: Louisiana
city: Metairie
country: United States
facility: Medpharmics, LLC ( Site 0157)
state: Louisiana
city: Silver Spring
country: United States
facility: Virgo-Carter Pediatrics ( Site 0275)
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center-Floating Hospital for Children ( Site 0129)
state: Massachusetts
city: Fall River
country: United States
facility: Pediatric Associates of Fall River ( Site 0183)
state: Massachusetts
city: Petal
country: United States
facility: MediSync Clinical Research Hattiesburg Clinic ( Site 0259)
state: Mississippi
city: Kansas City
country: United States
facility: Children's Mercy Clinics on Broadway ( Site 0171)
state: Missouri
city: Lincoln
country: United States
facility: Midwest Children's Health Research Institute, LLC ( Site 0109)
state: Nebraska
city: Lincoln
country: United States
facility: Midwest Children's Health Research Institute, LLC ( Site 0106)
state: Nebraska
city: Omaha
country: United States
facility: Children's Physicians, UNMC ( Site 0252)
state: Nebraska
city: Santa Fe
country: United States
facility: Southwest CARE Center ( Site 0161)
state: New Mexico
city: Bronx
country: United States
facility: Advantage Clinical Trials ( Site 0274)
state: New York
city: East Syracuse
country: United States
facility: Child Health Care Associates ( Site 0242)
state: New York
city: Liverpool
country: United States
facility: Child Health Care Associates ( Site 0267)
state: New York
city: Clyde
country: United States
facility: Haywood Pediatric and Adolescent Medicine Group ( Site 0248)
state: North Carolina
city: Raleigh
country: United States
facility: Capitol Pediatrics & Adolescent Center ( Site 0223)
state: North Carolina
city: Cleveland
country: United States
facility: Senders Pediatrics ( Site 0190)
state: Ohio
city: Dayton
country: United States
facility: Dayton Clinical Research ( Site 0188)
state: Ohio
city: Gresham
country: United States
facility: Cyn3rgy Research ( Site 0246)
state: Oregon
city: East Norriton
country: United States
facility: Pediatric Medical Associates ( Site 0239)
state: Pennsylvania
city: Erie
country: United States
facility: Allegheny Health & Wellness Pavilion West ( Site 0210)
state: Pennsylvania
city: Fort Washington
country: United States
facility: Lockman & Lubell Pediatrics ( Site 0166)
state: Pennsylvania
city: Hermitage
country: United States
facility: CCP- Kid's Way ( Site 0130)
state: Pennsylvania
city: Charleston
country: United States
facility: Palmetto Pediatrics, PA ( Site 0164)
state: South Carolina
city: Cheraw
country: United States
facility: Cheraw Pediatrics ( Site 0280)
state: South Carolina
city: Greenville
country: United States
facility: Parkside Pediatric ( Site 0125)
state: South Carolina
city: Kingsport
country: United States
facility: Holston Medical Group ( Site 0165)
state: Tennessee
city: Dallas
country: United States
facility: DFW Clinical Research ( Site 0111)
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch ( Site 0185)
state: Texas
city: Houston
country: United States
facility: Ventavia Research Group LLC ( Site 0142)
state: Texas
city: Houston
country: United States
facility: Pediatric Associates ( Site 0209)
state: Texas
city: Houston
country: United States
facility: Houston Clinical Research Network ( Site 0266)
state: Texas
city: Keller
country: United States
facility: Ventavia Research Group LLC ( Site 0139)
state: Texas
city: Lampasas
country: United States
facility: FMC Science ( Site 0115)
state: Texas
city: League City
country: United States
facility: University of Texas Medical Branch ( Site 0170)
state: Texas
city: Longview
country: United States
facility: DCOL Center for Clinical Research ( Site 0247)
state: Texas
city: Layton
country: United States
facility: Wee Care Pediatrics ( Site 0154)
state: Utah
city: Murray
country: United States
facility: Cottonwood Pediatrics ( Site 0153)
state: Utah
city: Provo
country: United States
facility: Pediatric Care ( Site 0138)
state: Utah
city: Roy
country: United States
facility: Wee Care Pediatrics-Roy ( Site 0174)
state: Utah
city: Saint George
country: United States
facility: Dixie Pediatrics ( Site 0260)
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah ( Site 0214)
state: Utah
city: Syracuse
country: United States
facility: Wee Care Pediatrics ( Site 0193)
state: Utah
city: Cheney
country: United States
facility: MultiCare Rockwood Cheney Clinic ( Site 0195)
state: Washington
city: Spokane
country: United States
facility: Multicare / Rockwood Clinic ( Site 0167)
state: Washington
city: Bayamon
country: Puerto Rico
facility: Cooperativa de Facultad Medica Sanacoop ( Site 0077)
city: Guayama
country: Puerto Rico
facility: Clinical Research of Puerto Rico ( Site 0075)
city: Ponce
country: Puerto Rico
facility: CAIMED Center - Ponce School of Medicine ( Site 0076)
city: San Juan
country: Puerto Rico
facility: San Juan Hospital ( Site 0079)
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico - Medical Science Campus ( Site 0078)
city: Trujillo Alto
country: Puerto Rico
facility: Elba Antoniette Perez Vargas MD-Private Practice ( Site 0081)
city: Muang
country: Thailand
facility: Khon Kaen University ( Site 0031)
state: Khon Kaen
city: Bangkok
country: Thailand
facility: Phramongkutklao Hospital ( Site 0033)
city: Bangkok
country: Thailand
facility: Siriraj Hospital ( Site 0032)
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital ( Site 0030)
city: Adana
country: Turkey
facility: Cukurova Uni Tip Fak Cocuk Saglıgı ve Hasta ABD ( Site 0060)
city: Ankara
country: Turkey
facility: Ankara Universitesi Tip Fakultesi ( Site 0053)
city: Izmir
country: Turkey
facility: Ege University Medical Faculty Hospital ( Site 0050)
city: Izmir
country: Turkey
facility: Dokuz Eylul University Faculty of Medicine ( Site 0054)
city: Kayseri
country: Turkey
facility: Erciyes Universitesi Tip Fakultesi ( Site 0057)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
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.