A Study to Evaluate the Safety and Immunogeneicity of Multivalent Pneumococcal Conjugate Vaccine in Healthy Adults
Single-blind, Single-center, Randomized, Active-controlled, Parallel Group, Phase I Study to Evaluate the Safety and Immunogenicity of Intramuscular Single Injection With Pneumococcal Conjugate Vaccine or Prevnar13 in Healthy Adults
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
phase-1 study pneumococcal conjugate vaccine study in healthy adults
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2018
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 25, 2018
CompletedFirst Posted
Study publicly available on registry
June 7, 2018
CompletedStudy Start
First participant enrolled
July 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 25, 2019
CompletedJune 13, 2018
May 1, 2018
9 months
May 25, 2018
June 11, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
Solicited adverse events
Solicited adverse events
Baseline(pre-vaccination) up to 7 days after
Unsolicited adverse events
Unsolicited adverse events
Baseline(pre-vaccination) up to 4 weeks after vaccination
Immediate reactions after vaccination
Immediate reactions after vaccination
Baseline(pre-vaccination) up to 30 minutes after vaccination
Secondary Outcomes (3)
Serotype-Specific Pneumococcal immunoglobulin G antibody Geometric Mean Concentrations (GMCs) 4 weeks After Vaccination
4 weeks After Vaccination
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 4 weeks After Vaccination
4 weeks After Vaccination
Proportion of subjects achieving 4-fold rise in Pneumococcal Opsonophagocytic Activity (OPA) titer at 4 weeks after vaccination
4 weeks after vaccination
Study Arms (3)
LBVE01
EXPERIMENTALMultivalent pneumococcal conjugate vaccine
LBVE02
EXPERIMENTALMultivalent pneumococcal conjugate vaccine
Prevnar13
ACTIVE COMPARATORMultivalent pneumococcal conjugate vaccine Prevnar13
Interventions
Multivalent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh
Multivalent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh
13-valent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh
Eligibility Criteria
You may qualify if:
- Healthy adult older than 19 years old and younger than 50 years old
- A subject who was informed of the purpose, method, and efficacy of the clinical study and signed the written informed consent form
You may not qualify if:
- A subject who participated in other clinical studies within 3 months before screening
- A subject who was vaccinated with other vaccines within 4 weeks before screening, or who is expected to receive other vaccination during the clinical study period
- A subject with medical history of hypersensitive reactions (e.g. anaphylaxis) to the test drug or its ingredients
- A subject who received immunoglobulin or blood-derived materials within 3 months before screening
- A subject with immunologic function disorders including congenital or acquired immunodeficiency disorders
- A subject who is receiving immunosuppressive therapy or drugs that can affect immunological reaction
- A subject with pyrexia of over 38 Celsius degrees on the day of the vaccination with the investigational products
- A subject with medical history of Invasive Pneumococcal Disease (IPD) or pneumonia caused by Streptococcus pneumoniae
- A subject who was vaccinated with any pneumococcal vaccine before screening
- A subject who received the vaccine containing diphtheria toxoid within 6 months before screening (e.g. adult Td vaccine)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LG Chemlead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Myoung-don Oh, M.D.
Seoul National University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2018
First Posted
June 7, 2018
Study Start
July 1, 2018
Primary Completion
April 1, 2019
Study Completion
July 25, 2019
Last Updated
June 13, 2018
Record last verified: 2018-05