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

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ClinicalTrials.gov Identifier: NCT02987972
Recruitment Status : Completed
First Posted : December 9, 2016
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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™.

Condition or disease Intervention/treatment Phase
Pneumococcal Infections Biological: V114 Lot 1 Biological: V114 Lot 2 Biological: Prevnar 13™ Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1052 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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
Actual Study Start Date : March 21, 2017
Actual Primary Completion Date : October 4, 2018
Actual Study Completion Date : October 4, 2018


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 Name: 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 Name: 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




Primary Outcome Measures :
  1. Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of >=0.35 mcg/mL for the 13 Common Serotypes [ Time Frame: 1 month after Dose 3 (Month 5) ]
    Serotype-specific pneumococcal IgG antibody will be measured using the Meso-Scale Discovery MSD Pn electrochemiluminescence assay (Pn ECL). The percentage of participants with serotype-specific IgG >=0.35 mcg/mL will be assessed.

  2. Percentage of Participants with an Adverse Event [ Time Frame: Up to 1 month after Dose 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 adverse event. The percentage of participants with one or more AEs will be assessed.

  3. Percentage of Participants who Discontinued the Study Due to an Adverse Event [ Time Frame: Up to 1 month after Dose 4 (up to 14 months) ]
    The percentage of participants who discontinued the study because of an AE (as defined above) will be assessed.

  4. Percentage of Participants with a Solicited Injection-site Adverse Event [ Time Frame: Up to 14 days after any vaccination ]
    Injection-site AEs solicited on the Vaccine Report Card will be redness, swelling, hard lump, and pain/tenderness. The percentage of participants with one or more solicited injection-site AEs will be assessed.

  5. Percentage of Participants with a Solicited Systemic Adverse Event [ Time Frame: Up to 14 days after any vaccination ]
    Systemic AEs solicited on the Vaccine Report Card will be fever, irritability, drowsiness, hive/welts, and appetite loss. The percentage of participants with one or more solicited systemic AEs will be assessed.

  6. Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common and the 2 V114-Unique Serotypes [ Time Frame: 1 month after Dose 3 (Month 5) ]
    Serotype-specific pneumococcal IgG antibody will be assayed using the Meso-Scale Discovery MSD Pn electrochemiluminescence assay. The geometric mean concentration of serotype-specific IgG will be assessed.


Secondary Outcome Measures :
  1. Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody [ Time Frame: Before Dose 4 (Month 10 to 13) and 1 month after Dose 4 (Month 11 to 14) ]
    Serotype-specific pneumococcal IgG antibody will be assayed using the Meso-Scale Discovery MSD Pn electrochemiluminescence assay. The geometric mean concentration of serotype-specific IgG will be assessed.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Weeks to 12 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02987972


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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02987972     History of Changes
Other Study ID Numbers: V114-008
2016-001117-25 ( EudraCT Number )
First Posted: December 9, 2016    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs