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A Study to Evaluate the Safety and Tolerability of V114 and Prevnar 13™ in Healthy Infants (V114-031/PNEU-LINK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03692871
Recruitment Status : Completed
First Posted : October 2, 2018
Last Update Posted : April 19, 2021
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE September 28, 2018
First Posted Date  ICMJE October 2, 2018
Last Update Posted Date April 19, 2021
Actual Study Start Date  ICMJE December 14, 2018
Actual Primary Completion Date March 26, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2018)
  • Percentage of Participants with a Solicited Injection-site Adverse Event [ Time Frame: Up to Day 14 after each study vaccination ]
    An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs will be redness/erythema, swelling, pain/tenderness, and hard lump/induration.
  • Percentage of Participants with a Solicited Systemic Adverse Event [ Time Frame: Up to Day 14 after each study vaccination ]
    An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs will be irritability, drowsiness/somnolence, appetite lost/decreased appetite, and hives or welts/urticaria.
  • Percentage of Participants with a Vaccine-related Serious Adverse Event [ Time Frame: Up to 6 months after Dose 4 (Month 19) ]
    A serious adverse event (SAE) is an AE that results in death, is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine will be determined by the investigator.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2018)
  • Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) at 30 days after Dose 3 [ Time Frame: 30 days after Dose 3 (Month 5) ]
    Immunoglobulin G for the 15 serotypes contained in V114 vaccine will be determined using a pneumococcal electrochemiluminescence (PnECL) assay. This Outcome Measure is part of the Premature Infant Substudy and will include premature infant participants only.
  • Geometric Mean Concentration of Serotype-specific IgG before Dose 4 [ Time Frame: Before dose 4 (Month 10-13) ]
    Immunoglobulin G for the 15 serotypes contained in V114 vaccine will be determined using a PnECL assay. This Outcome Measure is part of the Premature Infant Substudy and will include premature infant participants only.
  • Geometric Mean Concentration of Serotype-specific IgG at 30 Days after Dose 4 [ Time Frame: 30 days after Dose 4 (Month 11-14) ]
    Immunoglobulin G for the 15 serotypes contained in V114 vaccine will be determined using a PnECL assay. This Outcome Measure is part of the Premature Infant Substudy and will include premature infant participants only.
  • Percentage of Participants Meeting the Serotype-specific IgG Threshold of ≥0.35 µg/mL [ Time Frame: 30 days after Dose 3 (Month 5) ]
    Immunoglobulin G for the 15 serotypes contained in V114 vaccine will be determined using a PnECL assay. This Outcome Measure is part of the Premature Infant Substudy and will include premature infant participants only.
Original Secondary Outcome Measures  ICMJE Same as current
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 and Tolerability of V114 and Prevnar 13™ in Healthy Infants (V114-031/PNEU-LINK)
Official Title  ICMJE A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator Controlled Study to Evaluate the Safety and Tolerability of V114 in Healthy Infants (PNEU -LINK)
Brief Summary This study is designed to evaluate the safety and tolerability of V114 and Prevnar 13™ in healthy infants. This study will include both full-term infants (≥37 weeks gestational age) and premature infants (<37 weeks gestational age). Premature infants will be included in a Premature Infant Immunogenicity Substudy, which will assess immunogenicity and safety following administration of V114 or Prevnar 13™.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
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
    V114 pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose
  • Biological: Prevnar 13™
    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
    Participants will receive a single 0.5 mL intramuscular (IM) injection of double-blind V114 at approximately 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13). Nonstudy pediatric vaccines are permitted and should be administered according to the local recommended schedule.
    Intervention: Biological: V114
  • Active Comparator: Prevnar 13™
    Participants will receive a single 0.5 mL IM injection of double-blind Prevnar 13™ at approximately 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13). Nonstudy pediatric vaccines are permitted and should be administered according to the local recommended schedule.
    Intervention: Biological: Prevnar 13™
Publications * Not Provided

*   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: April 16, 2021)
2409
Original Estimated Enrollment  ICMJE
 (submitted: September 28, 2018)
2400
Actual Study Completion Date  ICMJE March 26, 2021
Actual Primary Completion Date March 26, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy (based on a review of medical history and physical examination) based on the clinical judgment of the investigator
  • Male or female approximately 2 months of age, from 42 days to 90 days inclusive, at the time of obtaining the informed consent
  • Have a legally acceptable representative who understands the study procedures, alternate treatments available, and risks involved with the study and voluntarily agrees to participate by giving written informed consent.

Exclusion Criteria:

  • History of Invasive Pneumococcal Disease (IPD) (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease
  • Known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV) or any diphtheria toxoid containing vaccine
  • Known or suspected impairment of immunological function
  • History of congenital or acquired immunodeficiency
  • Has or his/her mother has a documented human immunodeficiency virus (HIV) infection
  • Known or history of functional or anatomic asplenia
  • Failure to thrive based on the clinical judgment of the investigator
  • Known coagulation disorder contraindicating intramuscular vaccination
  • History of autoimmune disease (including but not limited to systemic lupus erythematosus, antiphospholipid syndrome, Behcet's disease, autoimmune thyroid disease, polymyositis and dermatomyositis, scleroderma, type 1 diabetes mellitus, or other autoimmune disorders)
  • Known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders
  • Received a dose of any pneumococcal vaccine prior to study entry
  • Received a blood transfusion or blood products, including immunoglobulins, before receipt of first dose of study vaccine
  • Participated in another clinical study of an investigational product before the beginning or anytime during the duration of the current clinical study. Participants enrolled in observational studies may be included.
  • Has any other reason that, in the opinion of the investigator, may interfere with the evaluation required by the study
  • Has an immediate family member who is investigational site or Sponsor staff directly involved with this study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 42 Days to 90 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Australia,   Finland,   Germany,   Israel,   Malaysia,   Peru,   Taiwan,   Thailand,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03692871
Other Study ID Numbers  ICMJE V114-031
V114-031 ( Other Identifier: Merck Protocol Number )
2018-003308-38 ( 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 April 2021

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