Clinical trial NCT03692871: A Study to Evaluate the Safety and Tolerability of V114 and Prevnar 13™ in Healthy Infants (V114-031/PNEU-LINK)
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-controlled Study to Evaluate the Safety and Tolerability of V114 in Healthy Infants (PNEU-LINK)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumococcal Infections
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2018-10-02
Enrollment: 2409
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: This study is designed to evaluate the safety and tolerability of V114 and Prevnar 13™ in healthy infants. This study will include both full-term infants (≥37 weeks gestational age) and premature infants (\<37 weeks gestational age). Premature infants will be included in a Premature Infant Immunogenicity Substudy, which will assess immunogenicity and safety following administration of V114 or Prevnar 13™.


Eligibility criteria: Inclusion Criteria:

* Healthy (based on a review of medical history and physical examination) based on the clinical judgment of the investigator
* Male or female approximately 2 months of age, from 42 days to 90 days inclusive, at the time of obtaining the informed consent
* Have 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:

* 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
* Known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV) or any diphtheria toxoid containing vaccine
* Known or suspected impairment of immunological function
* History of congenital or acquired immunodeficiency
* Has or his/her mother has a documented human immunodeficiency virus (HIV) infection
* Known or history of functional or anatomic asplenia
* Failure to thrive based on the clinical judgment of the investigator
* Known coagulation disorder contraindicating intramuscular vaccination
* 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)
* Known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders
* Received a dose of any pneumococcal vaccine prior to study entry
* Received a blood transfusion or blood products, including immunoglobulins, before receipt of first dose of study vaccine
* Participated in another clinical study of an investigational product before the beginning or anytime during the duration of the current clinical study. Participants enrolled in observational studies may be included.
* 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 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
timeFrame: Up to Day 14 after each study vaccination
measure: Percentage of Participants With a Solicited Systemic Adverse Event
timeFrame: Up to Day 14 after each study vaccination
measure: Percentage of Participants With a Vaccine-related Serious Adverse Event
timeFrame: Up to 6 months after Vaccination 4 (up to 19 months after Vaccination 1)
Secondary outcomes:
measure: Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only)
timeFrame: 30 days after Vaccination 3 (approximately 5 months after Vaccination 1)
measure: GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only)
timeFrame: Before Vaccination 4 (10-13 months after Vaccination 1)
measure: GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only)
timeFrame: 30 days after Vaccination 4 (11-14 months after Vaccination 1)
measure: Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only)
timeFrame: 30 days after Vaccination 3 (approximately 5 months after Vaccination 1)
Other outcomes:
Locations:
city: Downey
country: United States
facility: Premier Health Research Center, LLC ( Site 0005)
state: California
city: Huntington Beach
country: United States
facility: Beach Pediatrics ( Site 0040)
state: California
city: San Diego
country: United States
facility: Khruz Biotechnology Research Institute ( Site 0006)
state: California
city: San Jose
country: United States
facility: Kaiser Permanente - San Jose ( Site 0036)
state: California
city: Santa Clara
country: United States
facility: Kaiser Permanente - Santa Clara ( Site 0027)
state: California
city: Lake Mary
country: United States
facility: Children's Research, LLC ( Site 0025)
state: Florida
city: Naples
country: United States
facility: Advanced Research For Health Improvement LLC ( Site 0030)
state: Florida
city: Overland Park
country: United States
facility: Pediatric Partners, P.A. ( Site 0010)
state: Kansas
city: Louisville
country: United States
facility: Novak Center for Childrens Health ( Site 0033)
state: Kentucky
city: Metairie
country: United States
facility: Medpharmics, LLC ( Site 0037)
state: Louisiana
city: East Syracuse
country: United States
facility: Child Health Care Associates ( Site 0024)
state: New York
city: Dayton
country: United States
facility: Primedical Clinical Research ( Site 0035)
state: Ohio
city: Erie
country: United States
facility: Allegheny Health & Wellness Pavilion West ( Site 0034)
state: Pennsylvania
city: Hermitage
country: United States
facility: CCP- Kid's Way ( Site 0008)
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University ( Site 0029)
state: Pennsylvania
city: Charleston
country: United States
facility: Medical Research South, LLC ( Site 0013)
state: South Carolina
city: Houston
country: United States
facility: Pediatric Associates [Houston, TX] ( Site 0039)
state: Texas
city: League City
country: United States
facility: University of Texas Medical Branch ( Site 0018)
state: Texas
city: Layton
country: United States
facility: Tanner Clinic ( Site 0009)
state: Utah
city: Layton
country: United States
facility: Wee Care Pediatrics ( Site 0031)
state: Utah
city: Roy
country: United States
facility: Wee Care Pediatrics ( Site 0020)
state: Utah
city: Madison
country: United States
facility: University of Wisconsin American Family Children's Hospital ( Site 0023)
state: Wisconsin
city: Clayton
country: Australia
facility: Monash Children s Hospital ( Site 0093)
state: Victoria
city: Nedlands
country: Australia
facility: Perth Children s Hospital ( Site 0092)
city: North Adelaide
country: Australia
facility: Children, Youth and Woman's Health Service ( Site 0094)
city: Calgary
country: Canada
facility: Alberta Children s Hospital ( Site 0048)
state: Alberta
city: Vancouver
country: Canada
facility: Vaccine Evaluation Center BC Children s Hospital Research Institute ( Site 0046)
state: British Columbia
city: Halifax
country: Canada
facility: IWK Health Centre [Halifax, Canada] ( Site 0043)
state: Nova Scotia
city: Hamilton
country: Canada
facility: Hamilton Medical Research Group ( Site 0049)
state: Ontario
city: Sudbury
country: Canada
facility: Medicor Research Inc. ( Site 0041)
state: Ontario
city: Montreal
country: Canada
facility: CHU Sainte Justine ( Site 0047)
state: Quebec
city: Pierrefonds
country: Canada
facility: McGill University Health Centre - Vaccine Study Centre ( Site 0045)
state: Quebec
city: Quebec
country: Canada
facility: CHUQ - Unite de Recherche en Sante Publique ( Site 0042)
city: Espoo
country: Finland
facility: Espoon rokotetutkimuskeskus ( Site 0066)
city: Helsinki
country: Finland
facility: Tampereen yliopisto Etela-Helsingin Rokotetutkimusklinikka ( Site 0064)
city: Helsinki
country: Finland
facility: Ita-Helsingin Rokotetutkimuskeskus ( Site 0065)
city: Jarvenpaa
country: Finland
facility: Jarvenpaan rokotetutkimuskeskus ( Site 0067)
city: Kokkola
country: Finland
facility: Kokkolan rokotetutkimusklinikka ( Site 0071)
city: Oulu
country: Finland
facility: Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 0072)
city: Pori
country: Finland
facility: Porin Rokotetutkimusklinikka ( Site 0069)
city: Seinajoki
country: Finland
facility: Seinajoki Vaccine Research Center ( Site 0070)
city: Tampere
country: Finland
facility: Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 0063)
city: Turku
country: Finland
facility: Turun rokotetutkimuskeskus ( Site 0068)
city: Aschaffenburg
country: Germany
facility: Kinderarztpraxis ( Site 0124)
city: Bramsche
country: Germany
facility: Kinderarztpraxis ( Site 0123)
city: Hamburg
country: Germany
facility: Kinderarztpraxis Dr. Friedrich Kaiser & Dr. Marinesse ( Site 0085)
city: Huerth
country: Germany
facility: Kinderarztpraxis ( Site 0081)
city: Lauffen
country: Germany
facility: Kinderarztpraxis Dr. Muehlschlegel - Dr. Goetz ( Site 0122)
city: Moenchengladbach
country: Germany
facility: Kinderarztpraxis ( Site 0080)
city: Munchengladbach
country: Germany
facility: Kinderarztpraxis Matthias Donner Dr. M. Luechtrath ( Site 0091)
city: Schoenau
country: Germany
facility: Kinderarztpraxis ( Site 0084)
city: Wolfsburg
country: Germany
facility: Kinderaerztliche Gemeinschaftspraxis Drs. Westerholt/Matyas ( Site 0083)
city: Beer Sheva
country: Israel
facility: Soroka University Medical Center ( Site 0077)
city: Beer-Sheva
country: Israel
facility: Soroka University Medical Center - Ramot Family health center ( Site 0078)
city: Haifa
country: Israel
facility: Rambam Medical Center ( Site 0076)
city: Haifa
country: Israel
facility: Rambam Medical Center- Keriat Eliezer Family Health Center ( Site 0138)
city: Haifa
country: Israel
facility: Rambam Medical Center- Neve David Family Health Center ( Site 0139)
city: Hura
country: Israel
facility: Soroka Medical Center_ Hura Family health center ( Site 0137)
city: Rahat
country: Israel
facility: Soroka University Medical Center - Rahat Family health center ( Site 0079)
city: Ipoh
country: Malaysia
facility: Klinik Kesihatan Greentown ( Site 0132)
state: Perak
city: Kuching
country: Malaysia
facility: Sarawak General Hospital ( Site 0107)
state: Sarawak
city: Sibu
country: Malaysia
facility: Hospital Sibu ( Site 0111)
state: Sarawak
city: Kuala Lumpur
country: Malaysia
facility: Universiti Malaya Medical Center-Clinical Investigation Center ( Site 0108)
city: Pelabuhan Klang
country: Malaysia
facility: Klinik Kesihatan Pandamaran ( Site 0110)
city: Lima
country: Peru
facility: Hospital Nacional Docente Madre - Nino San Bartolome ( Site 0057)
city: Lima
country: Peru
facility: Instituto de Investigacion Nutricional ( Site 0058)
city: Trujillo
country: Peru
facility: Clinica Peruano Americana S.A. ( Site 0061)
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital ( Site 0100)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital ( Site 0097)
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital ( Site 0099)
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation. Linkou ( Site 0098)
city: Bangkok
country: Thailand
facility: Chulalongkorn University ( Site 0102)
city: Bangkok
country: Thailand
facility: Siriraj Hospital ( Site 0101)
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital ( Site 0103)
city: Hat Yai
country: Thailand
facility: Prince of Songkla University, Faculty of Medicine ( Site 0105)
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital. Khon Kaen University ( Site 0104)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Banniettis N, Horn M, Sadarangani M, Patel SM, Greenberg D, Oberdorfer P, Klein NP, Rupp R, Dagan R, Richmond P, Lumley J, Zhou W, Shi Y, Tamms G, Feemster K, Lupinacci R, Musey L, Bickham K; V114-031 (PNEU-LINK) study group. Safety and Tolerability of V114 Pneumococcal Vaccine in Infants: A Phase 3 Study. Pediatrics. 2023 Jul 1;152(1):e2022060428. doi: 10.1542/peds.2022-060428.