Study to Evaluate the Safety Tolerability and Immunogenicity of V114 in Healthy Japanese Infants (V114-033)

  • STATUS
    Recruiting
  • participants needed
    660
  • sponsor
    Merck Sharp & Dohme Corp.
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Updated on 16 February 2024
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polysaccharide
immunoglobulins
conjugate vaccine
immunoglobulin
immunoglobulin g (igg)

Summary

The purpose of this clinical study is to evaluate the safety and immunogenicity of a 4-dose schedule (3-dose primary series followed by a toddler dose) of V114 compared with Pneumococcal 13-valent Conjugate Vaccine (PCV13). The hypothesis is that V114 is non-inferior to PCV13 for the 13 shared serotypes between V114 and PCV13 based on response rates at 30 days following Dose 3 and that V114 is superior to PCV13 for the 2 serotypes unique to V114 based on the response rates at 30 days following Dose 3.

Details
Condition Pneumococcal infection
Age 1years - 1years
Treatment PCV13, V114
Clinical Study IdentifierNCT04384107
SponsorMerck Sharp & Dohme Corp.
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Japanese male or female
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. The legally acceptable representative may also provide consent for future biomedical research. However, the participant may participate in the main study without participating in future biomedical research

Exclusion Criteria

Has a 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
Has a known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV), or any diphtheria toxoid containing 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 human immunodeficiency virus (HIV) infection
Has or his/her mother has a documented hepatitis B surface antigen - positive test
Has known or history of functional or anatomic asplenia
Has failure to thrive based on the clinical judgement of the investigator
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 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 vaccine prior to study entry
Has received a blood transfusion or blood products, including immunoglobulins
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. Reasons may include, but are not limited to, being unable to keep appointments or planning to relocate far away during the study
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
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