Safety and Immunogenicity of V114 in Healthy Infants in South Korea (V114-036)

  • STATUS
    Recruiting
  • End date
    Mar 2, 2023
  • participants needed
    100
  • sponsor
    Merck Sharp & Dohme Corp.
Updated on 3 July 2021

Summary

The primary purpose of this phase 3, single-arm, open-label study is to evaluate the safety and immunogenicity of a 4-dose regimen of V114 administered to healthy infants in South Korea.

Details
Condition Pneumococcal infection, Pneumococcal Disease, streptococcus pneumoniae infections, pneumococcal infections
Treatment V114
Clinical Study IdentifierNCT04633226
SponsorMerck Sharp & Dohme Corp.
Last Modified on3 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

is a healthy South Korean male or female who is 42 to 90 days of age at the time of signing informed consent
has a parent or legally acceptable representative who understands study procedures, alternative treatments available, and risks involved and voluntarily agrees to participate by signing informed consent

Exclusion Criteria

has a history of invasive pneumococcal disease or known history of other culture positive pneumococcal disease
has known hypersensitivity to pneumococcal conjugate vaccine, any licensed pediatric vaccine to be administered concomitantly, or any diphtheria toxoid-containing vaccine
has had a recent febrile illness (rectal temperature 38.1C [100.5F] or axillary temperature 37.8C [100.0F]) within 72 hours prior to receipt of study vaccine
has known or suspected impairment of immunological function
has or his/her mother has human immunodeficiency virus (HIV) infection
has or his/her mother has hepatitis B surface antigen-positive test
has known or history of functional or anatomic asplenia
has a history of autoimmune disease
has a history or suspected history of neurological disorder
has received a pneumococcal vaccine prior to study entry
has received, or is anticipated to need, corticosteroid therapy
has received a blood transfusion of immunoglobulin products
has participated in another clinical study of an investigational product
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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