Clinical trial NCT02987972: A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Two Lots of V114 in Healthy Infants (V114-008)
Official title: A Phase II, Double-Blind, Randomized, Multicenter Trial to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in Healthy Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pneumococcal Infections
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2016-12-09
Enrollment: 1051
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
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, tolerability, and immunogenicity of two different lots of V114 in healthy infants 6 to 12 weeks (\>=42 days to \<=90 days) of age. The primary hypothesis of the study is that the proportion of participants receiving V114 who have serotype specific IgG \>=0.35 mcg/mL for each of pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F at 1 month after Dose 3 is non-inferior to that for recipients of Prevnar 13™.


Eligibility criteria: Inclusion Criteria:

* Infant approximately 2 months of age (42 days to 90 days), inclusive
* In good health

Exclusion Criteria:

* Prior administration of any pneumococcal vaccine
* Known hypersensitivity to any component of the pneumococcal conjugate vaccine or any diphtheria toxoid-containing vaccine
* Known or suspected impairment of immunological function
* History of congenital or acquired immunodeficiency (eg, splenomegaly)
* Mother has documented human immunodeficiency virus (HIV) infection
* Mother has documented hepatitis B surface antigen-positive test result
* Known or history of functional or anatomic asplenia
* History of failure to thrive
* History of a coagulation disorder
* History of autoimmune disease
* Known neurologic or cognitive behavioral disorder
* Expects to require systemic corticosteroids within 30 days after each vaccination during the trial
* Prior administration of a blood transfusion or blood products, including immunoglobulin
* Participated in another clinical trial of an investigational product
* History of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease

Primary outcomes:
measure: Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3
timeFrame: 1 month post vaccination 3 (Month 5)
measure: Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3
timeFrame: 1 month post Vaccination 3 (Month 5)
measure: Percentage of Participants Who Experience at Least 1 Adverse Event
timeFrame: Up to 1 month post Vaccination 4 (up to 14 months)
measure: Percentage of Participants Who Discontinued From the Study Due to an Adverse Event
timeFrame: Up to 1 month post Vaccination 4 (up to 14 months)
measure: Percentage of Participants With a Solicited Injection-site Adverse Event
timeFrame: Up to 14 days post any vaccination
measure: Percentage of Participants With a Solicited Systemic Adverse Event
timeFrame: Up to 14 days post any vaccination
Secondary outcomes:
measure: Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4
timeFrame: Before Vaccination 4 (Month 10 to 13)
measure: Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4
timeFrame: 1 month post vaccination 4 (Month 11-14)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Pediatric Research ( Site 0043)
state: Alabama
city: Dothan
country: United States
facility: Southeastern Pediatric Associates, P.A. ( Site 0079)
state: Alabama
city: Jonesboro
country: United States
facility: Children's Clinic of Jonesboro, PA ( Site 0054)
state: Arkansas
city: Downey
country: United States
facility: Premier Health Research Center, LLC ( Site 0035)
state: California
city: Palmdale
country: United States
facility: Sherif Khamis MD, Inc. ( Site 0044)
state: California
city: Roseville
country: United States
facility: Kaiser Permanente - Roseville ( Site 0045)
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente Clinical Trial - Sacramento ( Site 0076)
state: California
city: Bardstown
country: United States
facility: Kentucky Pediatric/Adult Research Inc ( Site 0037)
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville: Pediatric Clinical Trials Unit ( Site 0049)
state: Kentucky
city: Haughton
country: United States
facility: ACC Pediatric Research ( Site 0039)
state: Louisiana
city: Woburn
country: United States
facility: Woburn Pediatric Associates ( Site 0046)
state: Massachusetts
city: Omaha
country: United States
facility: Dundee Clinic ( Site 0063)
state: Nebraska
city: East Syracuse
country: United States
facility: Child Health Care Associates ( Site 0064)
state: New York
city: Syracuse
country: United States
facility: State University of New York Upstate Medical University ( Site 0065)
state: New York
city: Cincinnati
country: United States
facility: Pediatric Associates of Mt. Carmel, Inc. ( Site 0052)
state: Ohio
city: Cleveland
country: United States
facility: Senders Pediatrics ( Site 0058)
state: Ohio
city: Dayton
country: United States
facility: Ohio Pediatric Research Association ( Site 0060)
state: Ohio
city: East Norriton
country: United States
facility: Pediatric Medical Associates ( Site 0059)
state: Pennsylvania
city: Hermitage
country: United States
facility: Kid's Way Pediatrics ( Site 0036)
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University ( Site 0067)
state: Pennsylvania
city: Charleston
country: United States
facility: Coastal Pediatric Research ( Site 0070)
state: South Carolina
city: Kingsport
country: United States
facility: Holston Medical Group [Kingsport, TN] ( Site 0048)
state: Tennessee
city: Galveston
country: United States
facility: University of Texas Medical Branch at Galveston ( Site 0056)
state: Texas
city: League City
country: United States
facility: University of Texas Medical Branch at Galveston ( Site 0068)
state: Texas
city: Layton
country: United States
facility: Wee Care Pediatrics ( Site 0042)
state: Utah
city: Murray
country: United States
facility: Cottonwood Pediatrics ( Site 0041)
state: Utah
city: South Jordan
country: United States
facility: Copperview Medical Center ( Site 0062)
state: Utah
city: Charlottesville
country: United States
facility: Pediatric Research of Charlottesville, LLC ( Site 0066)
state: Virginia
city: Midlothian
country: United States
facility: Huguenot Pediatrics ( Site 0057)
state: Virginia
city: Ellensburg
country: United States
facility: Family Health Care of Ellensburg ( Site 0077)
state: Washington
city: Montreal
country: Canada
facility: CHU Ste-Justine ( Site 0084)
state: Quebec
city: Pierrefonds
country: Canada
facility: McGill University Health Centre - Vaccine Study Centre ( Site 0030)
state: Quebec
city: Quebec
country: Canada
facility: CHU de Quebec Universite de Laval ( Site 0031)
city: Aarhus N
country: Denmark
facility: Aarhus Universitetshospital-Skejby-Forskningsklinikken for Kvindesygdomme ( Site 0025)
city: Odense
country: Denmark
facility: OUH Klinisk Forsk center Gyn Obs D. ( Site 0024)
city: Espoo
country: Finland
facility: Tampereen yliopisto Espoon rokotetutkimusklinikka ( Site 0007)
city: Helsinki
country: Finland
facility: Tampereen yliopisto Etela-Helsingin rokotetutkimusklinikka ( Site 0005)
city: Helsinki
country: Finland
facility: Tampereen yliopisto Ita-Helsingin rokotetutkimusklinikka ( Site 0006)
city: Järvenpää
country: Finland
facility: Tampereen yliopisto Järvenpään rokotetutkimusklinikka ( Site 0003)
city: Oulu
country: Finland
facility: Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 0004)
city: Pori
country: Finland
facility: Tampereen yliopisto Porin rokotetutkimusklinikka ( Site 0008)
city: Tampere
country: Finland
facility: Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 0001)
city: Turku
country: Finland
facility: Tampereen yliopisto Turun rokotetutkimusklinikka ( Site 0002)
city: Beer-Sheva
country: Israel
facility: Soroka University Medical Center ( Site 0019)
city: Beer-Sheva
country: Israel
facility: Soroka University Medical Center - Rahat Family health center ( Site 0020)
city: Beer-Sheva
country: Israel
facility: Soroka University Medical Center - Ramot Family health center ( Site 0021)
city: Beer-Sheva
country: Israel
facility: Soroka University Medical Center - Vav Family health center ( Site 0022)
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Universitario de Santiago ( Site 0016)
city: Sevilla
country: Spain
facility: Unidad de Estudios e Investigacion IHP ( Site 0017)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Platt HL, Greenberg D, Tapiero B, Clifford RA, Klein NP, Hurley DC, Shekar T, Li J, Hurtado K, Su SC, Nolan KM, Acosta CJ, McFetridge RD, Bickham K, Musey LK; V114-008 Study Group. A Phase II Trial of Safety, Tolerability and Immunogenicity of V114, a 15-Valent Pneumococcal Conjugate Vaccine, Compared With 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants. Pediatr Infect Dis J. 2020 Aug;39(8):763-770. doi: 10.1097/INF.0000000000002765.