« Back to Search Results Notify Me When Search is Updated

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

ClinicalTrials.gov Identifier: NCT04633226 (view full study on clinicaltrials.gov)
Condition:  Pneumococcal disease
Status:  Completed


Official Title: A Phase 3, Single-Arm, Open-label Clinical Study to Evaluate the Safety and Immunogenicity of 4 doses of V114 Administered to Healthy Infants in South Korea.

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.

Interventional
Phase 3
58
February 2021
November 2022
November 2022
42 days to 90 days
All
Yes


CRITERIA

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 ≥38.1°C [≥100.5°F] or axillary temperature ≥37.8°C [≥100.0°F]) 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

No Contacts or Locations in US/Canada Provided

Click here to access ClinicalTrials.gov site to view results.


Clinical Study Reports

Synopsis  V114-036


Find a Study in US or Canada

Advanced Search    Search All Studies

RELATED INFORMATION





Copyright © 2026 · Merck & Co., Inc., Rahway, NJ, USA, and its affiliates. All rights reserved. · This site is intended only for residents of the United States.
Cookie Preferences  Privacy  Terms of Use  Consumer Health Data Privacy Policy  Your Privacy Choices   Accessibility  U.S. Corporate Site