A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Two Lots of V114 in Healthy Infants (V114-008)

A Phase II, Double-Blind, Randomized, Multicenter Trial to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in Healthy Infants

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™.

Study Overview

• Status: Completed
• Conditions: Pneumococcal Infections
• Intervention / Treatment: Biological: V114 Lot 1; Biological: V114 Lot 2; Biological: Prevnar 13™

• Study Type: Interventional
• Enrollment (Actual): 1051
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, H9H 4M7
    • CHU de Quebec Universite de Laval ( Site 0031)
  • Quebec
    • Montreal, Quebec, Canada, H9H 4M7
      • CHU Ste-Justine ( Site 0084)
    • Pierrefonds, Quebec, Canada, H9H 4M7
      • McGill University Health Centre - Vaccine Study Centre ( Site 0030)
• Denmark
  • Aarhus N, Denmark
    • Aarhus Universitetshospital-Skejby-Forskningsklinikken for Kvindesygdomme ( Site 0025)
  • Odense, Denmark
    • OUH Klinisk Forsk center Gyn Obs D. ( Site 0024)
• Finland
  • Espoo, Finland
    • Tampereen yliopisto Espoon rokotetutkimusklinikka ( Site 0007)
  • Helsinki, Finland
    • Tampereen yliopisto Etelä-Helsingin rokotetutkimusklinikka ( Site 0005)
  • Helsinki, Finland
    • Tampereen yliopisto Ita-Helsingin rokotetutkimusklinikka ( Site 0006)
  • Järvenpää, Finland
    • Tampereen yliopisto Järvenpään rokotetutkimusklinikka ( Site 0003)
  • Oulu, Finland
    • Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 0004)
  • Pori, Finland
    • Tampereen yliopisto Porin rokotetutkimusklinikka ( Site 0008)
  • Tampere, Finland
    • Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 0001)
  • Turku, Finland
    • Tampereen yliopisto Turun rokotetutkimusklinikka ( Site 0002)
• Israel
  • Beer-Sheva, Israel
    • Soroka University Medical Center ( Site 0019)
  • Beer-Sheva, Israel
    • Soroka University Medical Center - Rahat Family health center ( Site 0020)
  • Beer-Sheva, Israel
    • Soroka University Medical Center - Ramot Family health center ( Site 0021)
  • Beer-Sheva, Israel
    • Soroka University Medical Center - Vav Family health center ( Site 0022)
• Spain
  • Santiago de Compostela, Spain
    • Hospital Clinico Universitario de Santiago ( Site 0016)
  • Sevilla, Spain
    • Unidad de Estudios e Investigacion IHP ( Site 0017)
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Birmingham Pediatric Research ( Site 0043)
    • Dothan, Alabama, United States, 36305
      • Southeastern Pediatric Associates, P.A. ( Site 0079)
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • Children's Clinic of Jonesboro, PA ( Site 0054)
  • California
    • Downey, California, United States, 90241
      • Premier Health Research Center, LLC ( Site 0035)
    • Palmdale, California, United States, 93550
      • Sherif Khamis MD, Inc. ( Site 0044)
    • Roseville, California, United States, 95661
      • Kaiser Permanente - Roseville ( Site 0045)
    • Sacramento, California, United States, 95815
      • Kaiser Permanente Clinical Trial - Sacramento ( Site 0076)
  • Kentucky
    • Bardstown, Kentucky, United States, 40004
      • Kentucky Pediatric/Adult Research Inc ( Site 0037)
    • Louisville, Kentucky, United States, 40202
      • University of Louisville: Pediatric Clinical Trials Unit ( Site 0049)
  • Louisiana
    • Haughton, Louisiana, United States, 71037
      • ACC Pediatric Research ( Site 0039)
  • Massachusetts
    • Woburn, Massachusetts, United States, 01801
      • Woburn Pediatric Associates ( Site 0046)
  • Nebraska
    • Omaha, Nebraska, United States, 68132
      • Dundee Clinic ( Site 0063)
  • New York
    • East Syracuse, New York, United States, 13057
      • Child Health Care Associates ( Site 0064)
    • Syracuse, New York, United States, 13210
      • State University of New York Upstate Medical University ( Site 0065)
  • Ohio
    • Cincinnati, Ohio, United States, 45245
      • Pediatric Associates of Mt. Carmel, Inc. ( Site 0052)
    • Cleveland, Ohio, United States, 44121
      • Senders Pediatrics ( Site 0058)
    • Dayton, Ohio, United States, 45414
      • Ohio Pediatric Research Association ( Site 0060)
  • Pennsylvania
    • East Norriton, Pennsylvania, United States, 19401
      • Pediatric Medical Associates ( Site 0059)
    • Hermitage, Pennsylvania, United States, 16148
      • Kid's Way Pediatrics ( Site 0036)
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University ( Site 0067)
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Coastal Pediatric Research ( Site 0070)
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Holston Medical Group [Kingsport, TN] ( Site 0048)
  • Texas
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Branch at Galveston ( Site 0056)
    • League City, Texas, United States, 77573
      • University of Texas Medical Branch at Galveston ( Site 0068)
  • Utah
    • Layton, Utah, United States, 84041
      • Wee Care Pediatrics ( Site 0042)
    • Murray, Utah, United States, 84107
      • Cottonwood Pediatrics ( Site 0041)
    • South Jordan, Utah, United States, 84095
      • Copperview Medical Center ( Site 0062)
  • Virginia
    • Charlottesville, Virginia, United States, 22902
      • Pediatric Research of Charlottesville, LLC ( Site 0066)
    • Midlothian, Virginia, United States, 23113
      • Huguenot Pediatrics ( Site 0057)
  • Washington
    • Ellensburg, Washington, United States, 98926
      • Family Health Care of Ellensburg ( Site 0077)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 2 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: V114 Lot 1; Infants will receive a 0.5 mL intramuscular injection of V114 Lot 1 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)	Biological: V114 Lot 1; Lot 1: Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose; Other Names: V114-1
Experimental: V114 Lot 2; Infants will receive a 0.5 mL intramuscular injection of V114 Lot 2 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)	Biological: V114 Lot 2; Lot 2: Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose; Other Names: V114-2
Active Comparator: Prevnar 13™; Infants will receive a 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)	Biological: Prevnar 13™; Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) in each 0.5 ml dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Serotype-specific pneumococcal IgG antibody was measured using the Meso-Scale Discovery (MSD) Pneumococcal electrochemiluminescence assay (Pn ECL). The percentage of participants with serotype-specific IgG ≥0.35 µg/mL was summarized for each serotype.	1 month post vaccination 3 (Month 5)
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	Serotype-specific pneumococcal IgG antibody will be assayed using the Meso-Scale Discovery (MSD) Pn electrochemiluminescence assay. The geometric mean concentration (GMC) of serotype-specific IgG will be assessed.	1 month post Vaccination 3 (Month 5)
Percentage of Participants Who Experience at Least 1 Adverse Event	An adverse event (AE) is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants with one or more AEs was assessed.	Up to 1 month post Vaccination 4 (up to 14 months)
Percentage of Participants Who Discontinued From the Study Due to an Adverse Event	The percentage of participants who discontinued the study because of an AE (as defined above) was assessed.	Up to 1 month post Vaccination 4 (up to 14 months)
Percentage of Participants With a Solicited Injection-site Adverse Event	Injection-site AEs solicited on the Vaccine Report Card were redness, swelling, hard lump, and pain/tenderness. The percentage of participants with 1 or more solicited injection-site AEs was assessed.	Up to 14 days post any vaccination
Percentage of Participants With a Solicited Systemic Adverse Event	Systemic AEs solicited on the Vaccine Report Card were fever, irritability, drowsiness, hive/welts, and appetite loss. The percentage of participants with 1 or more solicited systemic AEs was assessed.	Up to 14 days post any vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Serotype-specific pneumococcal IgG antibody was assayed using the MSD Pn electrochemiluminescence assay.	Before Vaccination 4 (Month 10 to 13)
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	Serotype-specific pneumococcal IgG antibody was assayed using the MSD Pn electrochemiluminescence assay.	1 month post vaccination 4 (Month 11-14)

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2017
• Primary Completion (Actual): October 4, 2018
• Study Completion (Actual): October 4, 2018

Study Registration Dates

• First Submitted: December 6, 2016
• First Submitted That Met QC Criteria: December 6, 2016
• First Posted (Estimate): December 9, 2016

Study Record Updates

• Last Update Posted (Actual): October 23, 2019
• Last Update Submitted That Met QC Criteria: October 2, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Pneumococcal Infections; Physiological Effects of Drugs; Immunologic Factors; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: V114-008; 2016-001117-25 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No