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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
Results First Posted : October 23, 2019
Last Update Posted : October 23, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE December 6, 2016
First Posted Date  ICMJE December 9, 2016
Results First Submitted Date  ICMJE October 2, 2019
Results First Posted Date  ICMJE October 23, 2019
Last Update Posted Date October 23, 2019
Actual Study Start Date  ICMJE March 21, 2017
Actual Primary Completion Date October 4, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 2, 2019)
  • 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 [ Time Frame: 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.
  • 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 [ Time Frame: 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 Who Experience at Least 1 Adverse Event [ Time Frame: 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.
  • Percentage of Participants Who Discontinued From the Study Due to an Adverse Event [ Time Frame: 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.
  • Percentage of Participants With a Solicited Injection-site Adverse Event [ Time Frame: 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 [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 6, 2016)
  • Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of >=0.35 mcg/mL [ Time Frame: 1 month after Dose 3 (Month 5) ]
  • Percentage of Participants with an Adverse Event [ Time Frame: Up to 1 month after Dose 4 (up to 14 months) ]
  • 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) ]
  • Percentage of Participants With a Solicited Injection-site Adverse Event [ Time Frame: Up to 14 days after any vaccination ]
  • Percentage of Participants With a Solicited Systemic Adverse Event [ Time Frame: Up to 14 days after any vaccination ]
  • Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody [ Time Frame: 1 month after Dose 3 (Month 5) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2019)
  • 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 [ Time Frame: 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 [ Time Frame: 1 month post vaccination 4 (Month 11-14) ]
    Serotype-specific pneumococcal IgG antibody was assayed using the MSD Pn electrochemiluminescence assay.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 6, 2016)
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) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Two Lots of V114 in Healthy Infants (V114-008)
Official Title  ICMJE A Phase II, Double-Blind, Randomized, Multicenter Trial to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in Healthy Infants
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Pneumococcal Infections
Intervention  ICMJE
  • 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
  • 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
  • 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
Study Arms  ICMJE
  • 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)
    Intervention: Biological: V114 Lot 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)
    Intervention: Biological: V114 Lot 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)
    Intervention: Biological: Prevnar 13™
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 2, 2019)
1051
Original Estimated Enrollment  ICMJE
 (submitted: December 6, 2016)
1050
Actual Study Completion Date  ICMJE October 4, 2018
Actual Primary Completion Date October 4, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Weeks to 12 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Denmark,   Finland,   Israel,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02987972
Other Study ID Numbers  ICMJE V114-008
2016-001117-25 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP