Clinical trial NCT03620162: A Study to Evaluate the Interchangeability of V114 and Prevnar 13™ in Healthy Infants (V114-027/PNEU-DIRECTION)
Official title: A Phase 3, Multicenter, Randomized, Double-blind Study to Evaluate the Interchangeability of V114 and Prevnar 13™ With Respect to Safety, Tolerability, and Immunogenicity in Healthy Infants (PNEU-DIRECTION)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumococcal Infections
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2018-08-08
Enrollment: 900
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 goal of this study is to evaluate the safety, tolerability, and immunogenicity of the Pneumococcal Conjugate Vaccines (PCVs) V114 and Prevnar 13™ in healthy infants switched from Prevnar 13™ to V114 during the four-dose PCV immunization schedule.


Eligibility criteria: Inclusion Criteria:

* Is Healthy, based on clinical judgment 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 (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
* Has a known or suspected impairment of immunological function
* Has a history of congenital or acquired immunodeficiency
* Has or his/her mother has a documented human immunodeficiency virus (HIV) infection
* Has or his/her mother has a documented hepatitis B surface antigen - positive test
* Has known or history of functional or anatomic asplenia
* Has failure to thrive based on the clinical judgment of the investigator
* Has a known coagulation disorder contraindicating intramuscular vaccination
* Has a history of autoimmune disease (including but not limited to systemic lupus erythematosus, antiphospholipid syndrome, Behcet's disease, autoimmune thyroid disease, polymyositis and dermatomyositis, scleroderma, type 1 diabetes mellitus, or other autoimmune disorders)
* Has a known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders
* Has received a dose of any pneumococcal vaccine prior to study entry
* Has received \>1 dose of monovalent hepatitis B vaccine or hepatitis B based combination vaccine prior to study entry
* Has received a dose of rotavirus vaccine prior to study entry
* Has received a blood transfusion or blood products, including immunoglobulins
* Has participated in another clinical study of an investigational product before the beginning or anytime during the duration of the current clinical study
* Has any other reason that, in the opinion of the investigator, may interfere with the evaluation required by the study
* Has an immediate family member (e.g., parent/legal guardian or sibling) who is investigational site or Sponsor staff directly involved with this study.

Primary outcomes:
measure: Percentage of Participants With a Solicited Injection-site Adverse Event (AE)
timeFrame: Up to ~14 days after each vaccination
measure: Percentage of Participants With a Solicited Systemic AE
timeFrame: Up to ~14 days after each vaccination
measure: Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE)
timeFrame: Up to ~6 months after Vaccination 4 (up to ~19 months)
measure: Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4
timeFrame: 30 Days after Vaccination 4 (Months 11-14)
Secondary outcomes:
measure: Group 5 Versus Group 1 + Group 2: Percentage of Participants With Anti-Hepatitis B Surface Antigen (HBsAg) ≥10 mIU/mL at 30 Days Post Vaccination 3
timeFrame: 30 Days after Vaccination 3 (Month 5)
measure: Group 5 Versus Group 1 + Group 2: Geometric Mean Titer (GMT) of Anti-Rotavirus Immunoglobulin A (IgA) at 30 Days Post Vaccination 3
timeFrame: 30 Days after Vaccination 3 (Month 5)
measure: GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3
timeFrame: 30 Days after Vaccination 3 (Month 5)
measure: Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3
timeFrame: 30 Days after Vaccination 3 (Month 5)
measure: Group 5 Versus Group 1: GMC of Anti-PnP IgG For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4
timeFrame: 30 Days after Vaccination 4 (Months 11-14)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics ( Site 0015)
state: Alabama
city: Dothan
country: United States
facility: Southeastern Pediatric Associates, P.A. ( Site 0002)
state: Alabama
city: Jonesboro
country: United States
facility: Children's Clinic of Jonesboro, PA ( Site 0022)
state: Arkansas
city: Colorado Springs
country: United States
facility: Davita Medical Group ( Site 0012)
state: Colorado
city: Miami
country: United States
facility: Suncoast Research Associates, LLC ( Site 0035)
state: Florida
city: Bardstown
country: United States
facility: Kentucky Pediatric/Adult Research Inc ( Site 0011)
state: Kentucky
city: Fall River
country: United States
facility: Pediatric Associates of Fall River ( Site 0021)
state: Massachusetts
city: Lincoln
country: United States
facility: Midwest Children's Health Research Institute, LLC ( Site 0024)
state: Nebraska
city: Lincoln
country: United States
facility: Midwest Children's Health Research Institute, LLC ( Site 0003)
state: Nebraska
city: Lincoln
country: United States
facility: Midwest Children's Health Research Institute, LLC ( Site 0004)
state: Nebraska
city: Lincoln
country: United States
facility: Midwest Children's Health Research Institute, LLC ( Site 0001)
state: Nebraska
city: Liverpool
country: United States
facility: Summerwood Pediatrics ( Site 0009)
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center ( Site 0029)
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University ( Site 0008)
state: New York
city: Statesville
country: United States
facility: Piedmont Healthcare, PA ( Site 0025)
state: North Carolina
city: Charleston
country: United States
facility: Coastal Pediatric Research ( Site 0006)
state: South Carolina
city: Greenville
country: United States
facility: Parkside Pediatric ( Site 0007)
state: South Carolina
city: Kingsport
country: United States
facility: Holston Medical Group ( Site 0018)
state: Tennessee
city: Fort Worth
country: United States
facility: Ventavia Research Group LLC ( Site 0017)
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch ( Site 0023)
state: Texas
city: Murray
country: United States
facility: Wasatch Pediatrics-Cottonwood Office ( Site 0014)
state: Utah
city: Spokane
country: United States
facility: Multicare ( Site 0019)
state: Washington
city: Bayamon
country: Puerto Rico
facility: Cooperativa de Facultad Medica Sanacoop ( Site 0057)
city: Guayama
country: Puerto Rico
facility: Clinical Research of Puerto Rico ( Site 0050)
city: Ponce
country: Puerto Rico
facility: CAIMED Center - Ponce School of Medicine ( Site 0053)
city: San Juan
country: Puerto Rico
facility: San Juan Hospital ( Site 0056)
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico ( Site 0051)
city: Muang
country: Thailand
facility: Srinagarind Hospital. Khon Kaen University ( Site 0093)
state: Khon Kaen
city: Bangkok
country: Thailand
facility: Chulalongkorn University ( Site 0092)
city: Bangkok
country: Thailand
facility: Siriaj Hospital ( Site 0091)
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital ( Site 0090)
city: Ankara
country: Turkey
facility: Hacettepe University Faculty of Medicine ( Site 0070)
city: Eskisehir
country: Turkey
facility: Eskisehir Osmangazi University Faculty of Medicine ( Site 0071)
city: Izmir
country: Turkey
facility: Ege University Medical Faculty Hospital ( Site 0072)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Bili A, Dobson S, Quinones J, Phongsamart W, Oberdorfer P, Kosalaraksa P, Dagan R, Richmond P, Wilck M, Vallejos W, Nunn C, McFetridge R, Tamms G, Fu R, Lupinacci R, Musey L, Banniettis N, Bickham K; V114-027 PNEU-DIRECTION study group. A phase 3, multicenter, randomized, double-blind study to evaluate the interchangeability of V114, a 15-valent pneumococcal conjugate vaccine, and PCV13 with respect to safety, tolerability, and immunogenicity in healthy infants (PNEU-DIRECTION). Vaccine. 2023 Jan 16;41(3):657-665. doi: 10.1016/j.vaccine.2022.10.072. Epub 2022 Dec 13.