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Study to Evaluate the Safety, Tolerability, and Immunogenicity of Catch-up Vaccination Regimens of V114 in Healthy Infants, Children, and Adolescents (V114-024) (PNEU-PLAN)

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ClinicalTrials.gov Identifier: NCT03885934
Recruitment Status : Active, not recruiting
First Posted : March 22, 2019
Last Update Posted : February 21, 2020
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Description
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Brief Summary:
This is a study of V114 in healthy children who are either pneumococcal vaccine-naïve or who previously received a partial or full regimen of pneumococcal conjugate vaccine (PCV). Participants will be randomly assigned, in a 1:1 ratio, to receive either V114 or Prevnar 13®. Randomization will be stratified by age (7 months to 11 months, 12 months to 23 months [<2 years], ≥2 years to <6 years, and ≥6 years to 17 years [inclusive]). The primary objectives are to evaluate the safety and tolerability of V114 and to evaluate the anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 30 days following the last dose for each vaccination group. There is no formal hypothesis.

Condition or disease Intervention/treatment Phase
Pneumococcal Infections Biological: V114 Biological: Prevnar 13 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of Catch-up Vaccination Regimens of V114 in Healthy Infants, Children, and Adolescents (PNEU-PLAN)
Actual Study Start Date : June 25, 2019
Estimated Primary Completion Date : February 15, 2021
Estimated Study Completion Date : February 15, 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: V114
Each dose consists of 0.5 mL Intramuscular (IM) injection. Schedule A, 7 to 11 months of age, 3 doses: Dose 1 at randomization, Dose 2 at 1-2 months after Dose 1, and Dose 3 at 2-3 months after Dose 2 and at ≥12 months of age. Schedule B, 12 to 23 months of age, 2 doses: Dose 1 at randomization, and Dose 2 at 2-3 months after Dose 1. Schedule C, 2 to 17 years of age, 1 dose: Single dose at randomization.
 Biological: V114
V114 15-valent PVC containing 13 serotypes present in Prevnar 13® (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) and 2 unique serotypes (22F and 33F) in each 0.5 mL IM administration
Active Comparator: Prevnar 13
Each dose consists of 0.5 mL IM injection. Schedule A, 7 to 11 months of age, 3 doses: Dose 1 at randomization, Dose 2 at 1-2 months after Dose 1, and Dose 3 at 2-3 months after Dose 2 and at ≥12 months of age. Schedule B, 12 to 23 months of age, 2 doses: Dose 1 at randomization, and Dose 2 at 2-3 months after Dose 1. Schedule C, 2 to 17 years of age, 1 dose: Single dose at randomization.
 Biological: Prevnar 13
Prevnar 13® 13-valent PCV containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in each 0.5 mL IM administration.


Outcome Measures
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Primary Outcome Measures :
  1. Immunoglobulin G (IgG) GMCs for Each of the 15 Serotypes [ Time Frame: 30 days post final vaccination ]
    Sera from participants will be used to measure vaccine-induced anti-PnPs serotype-specific IgG for all the 15 serotypes using pneumococcal electrochemiluminescence (PnECL).

  2. Percentage of Participants that Report at Least 1 Solicited Injection-site Adverse Event (AE) [ Time Frame: Up to 14 days post any vaccination ]
    An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study drug or protocol-specified procedure is also an AE. The parent/guardian of the participant are to record the presence of any vaccination report card (VRC)-prompted injection-site AEs that occur in the 14 days after any vaccination. The percentage of participants with an injection-site AE prompted on the VRC (erythema, pain, and swelling) will be summarized.

  3. Percentage of Participants that Report at Least 1 Solicited Systemic AE [ Time Frame: Up to 14 days post any vaccination ]
    An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study vaccine or protocol-specified procedure is also an AE. The parent/guardian of the participant are to record the presence of any VRC-prompted systemic AEs that occur in the 14 days after any vaccination. The percentage of participants with a systemic AE will be summarized.

  4. Percentage of Participants that Report at Least 1 Vaccine-related AE [ Time Frame: 30 days post final vaccination ]
    An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study vaccine or protocol-specified procedure is also an AE. The percentage of participants that report at least 1 AE that was considered at least possibly related to the study vaccine will be summarized.


Secondary Outcome Measures :
  1. Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes [ Time Frame: 30 days post final vaccination ]
    Sera from participants will be used to measure vaccine-induced anti-PnPs serotype-specific IgG for all the 15 serotypes using PnECL. The percentage that achieve the GMC threshold value of ≥0.35 μg/mL will be summarized.


Eligibility Criteria
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Ages Eligible for Study:   7 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • Healthy
  • Not be pregnant or breastfeeding
  • Not be a woman of childbearing potential
  • If of a woman of childbearing potential, agree to follow the contraceptive guidance during the treatment period and for at least 6 weeks after the last dose of study intervention
  • Has 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)
  • Known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV) or any diphtheria toxoid-containing vaccine
  • Had a recent febrile illness occurring within 72 hours prior to receipt of study 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
  • Has failure to thrive based on the clinical judgement of the investigator
  • Has a bleeding disorder contraindicating intramuscular vaccination
  • Has a 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)
  • Has known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders
  • Is 7 to 23 months of age and has received a dose of a pneumococcal vaccine prior to study entry based on medical record. Participants ≥2 years of age could have received a PCV at least 8 weeks prior to study entry as follows: a partial regimen of Prevnar™,Synflorix™, or Prevnar 13™ or a full regimen of Prevnar™ or Synflorix™ based on local guidelines. Participants should not have received any dose of a pneumococcal polysaccharide vaccine
  • Meets one or more of the following systemic corticosteroid exclusion criteria: has received systemic corticosteroids (equivalent of ≥2 mg/kg total daily dose of prednisone or ≥20 mg/day for persons weighing >10 kg) for ≥14 consecutive days and has not completed this course of treatment at least 30 days prior to the first dose of study vaccine at randomization; has received or is expected to receive systemic corticosteroids exceeding physiologic replacement doses (approximately 5 mg/day prednisone equivalent) within 14 days prior to any dose of study vaccine; or is expected to require systemic corticosteroids within 30 days after any study vaccination during conduct of the study (Note: Topical, ophthalmic and inhaled steroids are permitted)
  • Has received other licensed non-live vaccines within 14 days before receipt of study vaccine. Exception: Inactivated influenza vaccine may be administered but must be given at least 7 days before receipt of study vaccine or at least 15 days after receipt of study vaccine
  • Has received a licensed live vaccine within 30 days before receipt of study vaccine
  • Has received a blood transfusion or blood products, including immunoglobulins, within 6 months before receipt of study vaccine
  • Has participated in another clinical study of an investigational product before the beginning or anytime during the duration of the current clinical study
Contacts and Locations
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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): NCT03885934


Locations
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Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Study Director Merck Sharp & Dohme Corp.
More Information
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT03885934    
Other Study ID Numbers: V114-024
V114-024 ( Other Identifier: Merck )
2018-003706-88 ( EudraCT Number )
First Posted: March 22, 2019    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
 Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs