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Trial record 1 of 4 for:    v114 | Phase 1
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Safety, Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants (V114-028)

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ClinicalTrials.gov Identifier: NCT03848065
Recruitment Status : Completed
First Posted : February 20, 2019
Last Update Posted : September 20, 2021
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Brief Summary:
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V114 administered subcutaneously or intramuscularly in healthy Japanese infants (3 months of age).

Condition or disease Intervention/treatment Phase
Pneumococcal Infections Biological: V114 Biological: Pneumococcal 13-valent Conjugate Vaccine (PCV13) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 133 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Phase I, Double-Blind, Randomized, Multicenter Trial of the Safety,Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants
Actual Study Start Date : April 2, 2019
Actual Primary Completion Date : June 24, 2020
Actual Study Completion Date : June 24, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: V114-SC
Infant participants will receive a single 0.5 mL subcutaneous (SC) injection of V114 on Visit 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age).
Biological: V114
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.
Other Names:
  • VAXNEUVANCE™
  • Pneumococcal 15-Valent Conjugate Vaccine

Experimental: V114-IM
Infant participants will receive a single 0.5 mL intramuscular (IM) injection of V114 at Visit 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age).
Biological: V114
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.
Other Names:
  • VAXNEUVANCE™
  • Pneumococcal 15-Valent Conjugate Vaccine

Active Comparator: PCV13-SC
Infant participants will receive a single 0.5 mL subcutaneous (SC) injection of pneumococcal 13-valent conjugate vaccine (PCV13) at Visit 1, 2, 3 and 5(approximately 3, 4, 5, and 12 to 15 months of age).
Biological: Pneumococcal 13-valent Conjugate Vaccine (PCV13)
13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F, serotype 6B in each 0.5. mL dose.
Other Name: PREVNAR 13®




Primary Outcome Measures :
  1. Percentage of Participants with a Solicited Injection-site Adverse Event [ Time Frame: Day 1 to Day 14 postvaccination ]
    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, swelling, and pain/tenderness.

  2. Percentage of Participants with a Solicited Systemic Adverse Event [ Time Frame: Day 1 to Day 14 postvaccination ]
    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 muscle pain, joint pain, headache, and tiredness.

  3. Percentage of Participants with a Vaccine-related Serious Adverse Event [ Time Frame: Day 1 to 1 month postvaccination (post-dose 4) ]
    A serious adverse event (SAE) is an AE that 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.


Secondary Outcome Measures :
  1. Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL [ Time Frame: One month postvaccination (post-dose 3) ]
    Assess the antipneumococcal polysaccharide (PnPs) serotype-specific IgG response rates (percentage of participants meeting serotype-specific IgG threshold value of ≥0.35 μg/mL) as measured by the pneumococcal polysaccharide electrochemiluminescence (Pn ECL) assay

  2. Serotype-specific IgG Geometric Mean Concentrations (GMCs) [ Time Frame: One month postvaccination (post-dose 3) ]
    Assess the anti-PnPs serotype-specific IgG GMCs as measured in the Pn ECL assay.



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy (based on a review of medical history and physical examination) based on the clinical judgment of the investigator.
  • Male or female 3 months of age inclusive (3 months of age to1 day prior to 4 months of age), at the time of obtaining the informed consent.
  • 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:

  • Has a history of invasive pneumococcal disease (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease.
  • Has a known hypersensitivity to vaccines, any component of the pneumococcal conjugate vaccine or any diphtheria toxoid-containing vaccine
  • Has any contraindication to the PCV13 and/or diphtheria, tetanus, acellular pertussis, inactivated polio vaccine (DTaP-IPV) being administered in the study (Refer to approved labeling for contraindication details on PCV13 and DTaPIPV vaccine).
  • Has a recent febrile illness (axillary temperature ≥37.5°C) occurring within 72 hours prior to receipt of study vaccine.
  • Has a known or suspected impairment of immunological function.
  • Has a history of congenital or acquired immunodeficiency.
  • Has or his/her mother has a documented hepatitis B surface antigen - positive test.
  • Has a known functional or anatomic asplenia.
  • Has failure to thrive based on the clinical judgement of the investigator.
  • Has thrombocytopenia or a known coagulation disorder contraindicating intramuscular vaccination.
  • Has a history of autoimmune disease (including but not limited to systemic lupus erythematosus, antiphospholipid syndrome, Bechet's disease, autoimmune thyroid disease, polymyositis and dermatomyositis, scleroderma, type 1 diabetes mellitus, or other autoimmune disorders).
  • Has a known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders.
  • Has received a dose of any pneumococcal and/or DTaP-IPV vaccine (or vaccine containing any DTaP-IPV component) prior to study entry.
  • 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/d for persons weighing > 10 kg) for ≥ 14 consecutive days and has not completed this course of treatment at least 30 days prior to trial randomization, has received systemic corticosteroids within 14 days prior to the first dose of study vaccine at randomization, and is expected to require systemic corticosteroids (equivalent of ≥ 2 mg/kg total daily dose of prednisone or ≥ 20 mg/d for persons weighing > 10 kg) for ≥ 14 consecutive days within 14 days prior to or 30 days after each vaccination during conduct of the study.(Topical, ophthalmic and inhaled steroids are permitted.)
  • Has received other licensed non-live vaccines within the 14 days before receipt of first dose of study vaccine.
  • Has received a licensed live virus vaccine within the 28 days before receipt of first dose of study vaccine.
  • Has received a blood transfusion or blood products, including immunoglobulins before receipt of first dose 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. Participants enrolled in observational studies may be included; these will be reviewed on a case by case basis for approval by the Sponsor.
  • Has any other reason that, in the opinion of the investigator, may interfere with the evaluation required by the study. (Refer to the Vaccination Guideline in Japan). Reasons may include, but are not limited to, being unable to keep appointments or planning to relocate during the study.
  • Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.

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): NCT03848065


Locations
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Japan
Meitetsu Hospital ( Site 2805)
Nagoya, Aichi, Japan, 451-8511
Sotobo Children's Clinic ( Site 2807)
Isumi, Chiba, Japan, 299-4503
Hidaka Children's Clinic ( Site 2803)
Dazaifu, Fukuoka, Japan, 818-0134
Isesaki Municipal Hospital ( Site 2806)
Isesaki, Gunma, Japan, 372-0817
Kawasaki Municipal Hospital ( Site 2802)
Kawasaki, Kanagawa, Japan, 210-0013
Yokosuka Kyosai Hospital ( Site 2804)
Yokosuka, Kanagawa, Japan, 238-8558
Suita Municipal Hospital ( Site 2801)
Suita, Osaka, Japan, 564-8567
Kobayashi Pediatric Clinic ( Site 2816)
Fujieda, Shizuoka, Japan, 426-0067
Nishida Kodomo Clinic ( Site 2811)
Tama, Tokyo, Japan, 206-0025
Fukui Aiiku Hospital ( Site 2809)
Fukui, Japan, 910-0833
Fukui-ken Saiseikai Hospital ( Site 2813)
Fukui, Japan, 918-8503
Kubota Children's Clinic ( Site 2815)
Osaka, Japan, 544-0033
Japanese Red Cross Shizuoka Hospital ( Site 2817)
Shizuoka, Japan, 420-0853
Hosaka Children's Clinic ( Site 2814)
Tokyo, Japan, 112-0001
Sponsors and Collaborators
Merck Sharp & Dohme LLC
Investigators
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Study Director: Medical Director Merck Sharp & Dohme LLC
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Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT03848065    
Other Study ID Numbers: V114-028
V114-028 ( Other Identifier: Merck Protocol Number )
194669 ( Registry Identifier: JAPIC-CTI )
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: September 20, 2021
Last Verified: September 2021
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: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Merck Sharp & Dohme LLC:
Pneumococcal Vaccines
Additional relevant MeSH terms:
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Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs