A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Two Lots of V114 in Healthy Infants (V114-008)
- Conditions
- Pneumococcal Infections
- Interventions
- Biological: V114 Lot 1Biological: V114 Lot 2Biological: Prevnar 13™
- Registration Number
- NCT02987972
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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™.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1051
- Infant approximately 2 months of age (42 days to 90 days), inclusive
- In good health
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description V114 Lot 1 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) V114 Lot 2 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) Prevnar 13™ 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)
- Primary Outcome Measures
Name Time Method 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 1 month post vaccination 3 (Month 5) 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.
Percentage of Participants Who Discontinued From the Study Due to an Adverse Event Up to 1 month post Vaccination 4 (up to 14 months) The percentage of participants who discontinued the study because of an AE (as defined above) was assessed.
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 1 month post Vaccination 3 (Month 5) 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.
Percentage of Participants With a Solicited Injection-site Adverse Event Up to 14 days post any vaccination 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.
Percentage of Participants With a Solicited Systemic Adverse Event Up to 14 days post any vaccination 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.
Percentage of Participants Who Experience at Least 1 Adverse Event Up to 1 month post Vaccination 4 (up to 14 months) 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.
- Secondary Outcome Measures
Name Time Method 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) Serotype-specific pneumococcal IgG antibody was assayed using the MSD Pn electrochemiluminescence assay.
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) Serotype-specific pneumococcal IgG antibody was assayed using the MSD Pn electrochemiluminescence assay.
Trial Locations
- Locations (49)
Hospital Clinico Universitario de Santiago ( Site 0016)
🇪🇸Santiago de Compostela, Spain
Unidad de Estudios e Investigacion IHP ( Site 0017)
🇪🇸Sevilla, Spain
Premier Health Research Center, LLC ( Site 0035)
🇺🇸Downey, California, United States
Sherif Khamis MD, Inc. ( Site 0044)
🇺🇸Palmdale, California, United States
Kaiser Permanente - Roseville ( Site 0045)
🇺🇸Roseville, California, United States
Kaiser Permanente Clinical Trial - Sacramento ( Site 0076)
🇺🇸Sacramento, California, United States
University of Louisville: Pediatric Clinical Trials Unit ( Site 0049)
🇺🇸Louisville, Kentucky, United States
ACC Pediatric Research ( Site 0039)
🇺🇸Haughton, Louisiana, United States
Woburn Pediatric Associates ( Site 0046)
🇺🇸Woburn, Massachusetts, United States
Ohio Pediatric Research Association ( Site 0060)
🇺🇸Dayton, Ohio, United States
Pediatric Medical Associates ( Site 0059)
🇺🇸East Norriton, Pennsylvania, United States
Kid's Way Pediatrics ( Site 0036)
🇺🇸Hermitage, Pennsylvania, United States
Coastal Pediatric Research ( Site 0070)
🇺🇸Charleston, South Carolina, United States
Wee Care Pediatrics ( Site 0042)
🇺🇸Layton, Utah, United States
University of Texas Medical Branch at Galveston ( Site 0068)
🇺🇸League City, Texas, United States
Copperview Medical Center ( Site 0062)
🇺🇸South Jordan, Utah, United States
Cottonwood Pediatrics ( Site 0041)
🇺🇸Murray, Utah, United States
Pediatric Research of Charlottesville, LLC ( Site 0066)
🇺🇸Charlottesville, Virginia, United States
Huguenot Pediatrics ( Site 0057)
🇺🇸Midlothian, Virginia, United States
Family Health Care of Ellensburg ( Site 0077)
🇺🇸Ellensburg, Washington, United States
Tampereen yliopisto Järvenpään rokotetutkimusklinikka ( Site 0003)
🇫🇮Järvenpää, Finland
Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 0004)
🇫🇮Oulu, Finland
Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 0001)
🇫🇮Tampere, Finland
Aarhus Universitetshospital-Skejby-Forskningsklinikken for Kvindesygdomme ( Site 0025)
🇩🇰Aarhus N, Denmark
OUH Klinisk Forsk center Gyn Obs D. ( Site 0024)
🇩🇰Odense, Denmark
Southeastern Pediatric Associates, P.A. ( Site 0079)
🇺🇸Dothan, Alabama, United States
Pediatric Associates of Mt. Carmel, Inc. ( Site 0052)
🇺🇸Cincinnati, Ohio, United States
Senders Pediatrics ( Site 0058)
🇺🇸Cleveland, Ohio, United States
Holston Medical Group [Kingsport, TN] ( Site 0048)
🇺🇸Kingsport, Tennessee, United States
University of Texas Medical Branch at Galveston ( Site 0056)
🇺🇸Galveston, Texas, United States
Birmingham Pediatric Research ( Site 0043)
🇺🇸Birmingham, Alabama, United States
State University of New York Upstate Medical University ( Site 0065)
🇺🇸Syracuse, New York, United States
Kentucky Pediatric/Adult Research Inc ( Site 0037)
🇺🇸Bardstown, Kentucky, United States
Children's Clinic of Jonesboro, PA ( Site 0054)
🇺🇸Jonesboro, Arkansas, United States
Child Health Care Associates ( Site 0064)
🇺🇸East Syracuse, New York, United States
Thomas Jefferson University ( Site 0067)
🇺🇸Philadelphia, Pennsylvania, United States
Tampereen yliopisto Etela-Helsingin rokotetutkimusklinikka ( Site 0005)
🇫🇮Helsinki, Finland
Tampereen yliopisto Ita-Helsingin rokotetutkimusklinikka ( Site 0006)
🇫🇮Helsinki, Finland
Soroka University Medical Center - Vav Family health center ( Site 0022)
🇮🇱Beer-Sheva, Israel
Tampereen yliopisto Espoon rokotetutkimusklinikka ( Site 0007)
🇫🇮Espoo, Finland
Tampereen yliopisto Porin rokotetutkimusklinikka ( Site 0008)
🇫🇮Pori, Finland
Tampereen yliopisto Turun rokotetutkimusklinikka ( Site 0002)
🇫🇮Turku, Finland
Soroka University Medical Center - Rahat Family health center ( Site 0020)
🇮🇱Beer-Sheva, Israel
Soroka University Medical Center ( Site 0019)
🇮🇱Beer-Sheva, Israel
Soroka University Medical Center - Ramot Family health center ( Site 0021)
🇮🇱Beer-Sheva, Israel
CHU Ste-Justine ( Site 0084)
🇨🇦Montreal, Quebec, Canada
McGill University Health Centre - Vaccine Study Centre ( Site 0030)
🇨🇦Pierrefonds, Quebec, Canada
CHU de Quebec Universite de Laval ( Site 0031)
🇨🇦Quebec, Canada
Dundee Clinic ( Site 0063)
🇺🇸Omaha, Nebraska, United States