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

NCT02987972 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: V114-0082016-001117-25
• Study Type: interventional
• Target: 1,051
• Locations: 6 countries
• Sites: 49

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™.

Conditions

Pneumococcal Infections

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• 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

  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

  1 month post vaccination 4 (Month 11-14)

Study Arms (3)

V114 Lot 1

EXPERIMENTAL

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

V114 Lot 2

EXPERIMENTAL

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

Prevnar 13™

ACTIVE COMPARATOR

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™

Interventions

V114 Lot 1 BIOLOGICAL

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

Also known as: V114-1

V114 Lot 1

V114 Lot 2 BIOLOGICAL

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

Also known as: V114-2

V114 Lot 2

Prevnar 13™ BIOLOGICAL

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

Prevnar 13™

Eligibility Criteria

• Age: 6 Weeks - 12 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (49)

Birmingham Pediatric Research ( Site 0043)

Birmingham, Alabama, 35205, United States

Location

Southeastern Pediatric Associates, P.A. ( Site 0079)

Dothan, Alabama, 36305, United States

Location

Children's Clinic of Jonesboro, PA ( Site 0054)

Jonesboro, Arkansas, 72401, United States

Location

Premier Health Research Center, LLC ( Site 0035)

Downey, California, 90241, United States

Location

Sherif Khamis MD, Inc. ( Site 0044)

Palmdale, California, 93550, United States

Location

Kaiser Permanente - Roseville ( Site 0045)

Roseville, California, 95661, United States

Location

Kaiser Permanente Clinical Trial - Sacramento ( Site 0076)

Sacramento, California, 95815, United States

Location

Kentucky Pediatric/Adult Research Inc ( Site 0037)

Bardstown, Kentucky, 40004, United States

Location

University of Louisville: Pediatric Clinical Trials Unit ( Site 0049)

Louisville, Kentucky, 40202, United States

Location

ACC Pediatric Research ( Site 0039)

Haughton, Louisiana, 71037, United States

Location

Woburn Pediatric Associates ( Site 0046)

Woburn, Massachusetts, 01801, United States

Location

Dundee Clinic ( Site 0063)

Omaha, Nebraska, 68132, United States

Location

Child Health Care Associates ( Site 0064)

East Syracuse, New York, 13057, United States

Location

State University of New York Upstate Medical University ( Site 0065)

Syracuse, New York, 13210, United States

Location

Pediatric Associates of Mt. Carmel, Inc. ( Site 0052)

Cincinnati, Ohio, 45245, United States

Location

Senders Pediatrics ( Site 0058)

Cleveland, Ohio, 44121, United States

Location

Ohio Pediatric Research Association ( Site 0060)

Dayton, Ohio, 45414, United States

Location

Pediatric Medical Associates ( Site 0059)

East Norriton, Pennsylvania, 19401, United States

Location

Kid's Way Pediatrics ( Site 0036)

Hermitage, Pennsylvania, 16148, United States

Location

Thomas Jefferson University ( Site 0067)

Philadelphia, Pennsylvania, 19107, United States

Location

Coastal Pediatric Research ( Site 0070)

Charleston, South Carolina, 29414, United States

Location

Holston Medical Group [Kingsport, TN] ( Site 0048)

Kingsport, Tennessee, 37660, United States

Location

University of Texas Medical Branch at Galveston ( Site 0056)

Galveston, Texas, 77555, United States

Location

University of Texas Medical Branch at Galveston ( Site 0068)

League City, Texas, 77573, United States

Location

Wee Care Pediatrics ( Site 0042)

Layton, Utah, 84041, United States

Location

Cottonwood Pediatrics ( Site 0041)

Murray, Utah, 84107, United States

Location

Copperview Medical Center ( Site 0062)

South Jordan, Utah, 84095, United States

Location

Pediatric Research of Charlottesville, LLC ( Site 0066)

Charlottesville, Virginia, 22902, United States

Location

Huguenot Pediatrics ( Site 0057)

Midlothian, Virginia, 23113, United States

Location

Family Health Care of Ellensburg ( Site 0077)

Ellensburg, Washington, 98926, United States

Location

CHU Ste-Justine ( Site 0084)

Montreal, Quebec, H9H 4M7, Canada

Location

McGill University Health Centre - Vaccine Study Centre ( Site 0030)

Pierrefonds, Quebec, H9H 4M7, Canada

Location

CHU de Quebec Universite de Laval ( Site 0031)

Québec, Quebec, H9H 4M7, Canada

Location

Aarhus Universitetshospital-Skejby-Forskningsklinikken for Kvindesygdomme ( Site 0025)

Aarhus N, Denmark

Location

OUH Klinisk Forsk center Gyn Obs D. ( Site 0024)

Odense, Denmark

Location

Tampereen yliopisto Espoon rokotetutkimusklinikka ( Site 0007)

Espoo, Finland

Location

Tampereen yliopisto Etela-Helsingin rokotetutkimusklinikka ( Site 0005)

Helsinki, Finland

Location

Tampereen yliopisto Ita-Helsingin rokotetutkimusklinikka ( Site 0006)

Helsinki, Finland

Location

Tampereen yliopisto Järvenpään rokotetutkimusklinikka ( Site 0003)

Jarvenpaa, Finland

Location

Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 0004)

Oulu, Finland

Location

Tampereen yliopisto Porin rokotetutkimusklinikka ( Site 0008)

Pori, Finland

Location

Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 0001)

Tampere, Finland

Location

Tampereen yliopisto Turun rokotetutkimusklinikka ( Site 0002)

Turku, Finland

Location

Soroka University Medical Center ( Site 0019)

Beersheba, Israel

Location

Soroka University Medical Center - Rahat Family health center ( Site 0020)

Beersheba, Israel

Location

Soroka University Medical Center - Ramot Family health center ( Site 0021)

Beersheba, Israel

Location

Soroka University Medical Center - Vav Family health center ( Site 0022)

Beersheba, Israel

Location

Hospital Clinico Universitario de Santiago ( Site 0016)

Santiago de Compostela, Spain

Location

Unidad de Estudios e Investigacion IHP ( Site 0017)

Seville, Spain

Location

Related Publications (1)

• 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.

  PMID: 32639460 DERIVED

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

13-valent pneumococcal vaccine

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: December 9, 2016
• Study Start: March 21, 2017
• Primary Completion: October 4, 2018
• Study Completion: October 4, 2018
• Last Updated: October 23, 2019
• Results First Posted: October 23, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share

Locations

DK (2); FI (8); IL (4); ES (2); CA (3); US (30)