A Study to Evaluate the Safety and Immunogenecity of LBVE(Multivalent Pneumococcal Conjugate Vaccine) in Healthy Infants
NCT ID: NCT03467984
Last Updated: 2019-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
230 participants
INTERVENTIONAL
2018-05-25
2019-03-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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LBVE
Infants will receive a 0.5mL intramuscular injection of LBVE at 6,10 and 14 weeks of age
LBVE
Multivalent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh
Prevnar13
Infants will receive a 0.5mL intramuscular injection of Prevnar13 at 6,10 and 14 weeks of age
Prevnar13
13-valent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh
Interventions
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LBVE
Multivalent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh
Prevnar13
13-valent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh
Eligibility Criteria
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Inclusion Criteria
* The parents or LAR(Legally authorized representative) able to understand and comply with planned study procedures.
* Signed informed consent by subject's parents or LAR(Legally authorized representative)
Exclusion Criteria
* Receipt of immunoglobulin or blood-derived product before the study
* Known or suspected immune disorder, or received immunosuppressive therapy
* Known major congenital malformation or serious chronic disorder
* Participation in another interventional trial
6 Weeks
8 Weeks
ALL
Yes
Sponsors
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LG Chem
INDUSTRY
Responsible Party
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Locations
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LG chem
Seoul, Gangseo-Gu, South Korea
Countries
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Other Identifiers
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LG-VECL002
Identifier Type: -
Identifier Source: org_study_id
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