Back to resultsA Study to Evaluate the Safety and Immunogenecity of LBVE(Multivalent Pneumococcal Conjugate Vaccine) in Healthy Infants
Primary Purpose
Pneumococcal Infection
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
LBVE
Prevnar13
Sponsored by
About this trial
This is an interventional prevention trial for Pneumococcal Infection
Eligibility Criteria
Inclusion Criteria:
- Healthy infants of either sex who have reached at least 42 days (6 weeks) of age and not more than 56 days (8 weeks) of age at the time of enrollment.
- 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:
- Previously received any pneumococcal vaccine
- 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
Sites / Locations
- LG chem
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LBVE
Prevnar13
Arm Description
Infants will receive a 0.5mL intramuscular injection of LBVE at 6,10 and 14 weeks of age
Infants will receive a 0.5mL intramuscular injection of Prevnar13 at 6,10 and 14 weeks of age
Outcomes
Primary Outcome Measures
Proportion of subjects achieving pneumococcal serotype-specific IgG >= 0.35 ug/ml
Pneumococcal serotype-specific IgG geometic mean concentration (GMC) ratios
Secondary Outcome Measures
Proportion of subjects achieving targeted pneumococcal serotype-specific opsonophagocytic assay (OPA) titer
Pneumococcal serotype-specific OPA geometic mean titer (GMT) ratios
Solicited adverse events
Unsolicited adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03467984
Brief Title
A Study to Evaluate the Safety and Immunogenecity of LBVE(Multivalent Pneumococcal Conjugate Vaccine) in Healthy Infants
Official Title
A Single-blind, Multi-center, Randomized, Active-controlled, Parallel Group, Phase II Study to Evaluate the Safety and Immunogenicity of Intramuscular Three Injections With LBVE(Multivalent Pneumococcal Conjugate Vaccine) Compared to Prevnar13 in Healthy Infants
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
May 25, 2018 (Actual)
Primary Completion Date
October 5, 2018 (Actual)
Study Completion Date
March 27, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LG Chem
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and immunogenicity of LBVE (Multivalent Pneumococcal Conjugate Vaccine) in healthy infants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumococcal Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
230 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LBVE
Arm Type
Experimental
Arm Description
Infants will receive a 0.5mL intramuscular injection of LBVE at 6,10 and 14 weeks of age
Arm Title
Prevnar13
Arm Type
Active Comparator
Arm Description
Infants will receive a 0.5mL intramuscular injection of Prevnar13 at 6,10 and 14 weeks of age
Intervention Type
Biological
Intervention Name(s)
LBVE
Intervention Description
Multivalent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh
Intervention Type
Biological
Intervention Name(s)
Prevnar13
Intervention Description
13-valent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh
Primary Outcome Measure Information:
Title
Proportion of subjects achieving pneumococcal serotype-specific IgG >= 0.35 ug/ml
Time Frame
4 weeks after 3rd(last) vaccination
Title
Pneumococcal serotype-specific IgG geometic mean concentration (GMC) ratios
Time Frame
4 weeks after 3rd(last) vaccination
Secondary Outcome Measure Information:
Title
Proportion of subjects achieving targeted pneumococcal serotype-specific opsonophagocytic assay (OPA) titer
Time Frame
4 weeks after 3rd(last) vaccination
Title
Pneumococcal serotype-specific OPA geometic mean titer (GMT) ratios
Time Frame
4 weeks after 3rd(last) vaccination
Title
Solicited adverse events
Time Frame
Baseline(pre-vaccination) up to 7 days after each vaccination
Title
Unsolicited adverse events
Time Frame
Baseline(pre-vaccination) up to 4 weeks after 3rd(last) vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Weeks
Maximum Age & Unit of Time
8 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy infants of either sex who have reached at least 42 days (6 weeks) of age and not more than 56 days (8 weeks) of age at the time of enrollment.
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:
Previously received any pneumococcal vaccine
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
Facility Information:
Facility Name
LG chem
City
Seoul
State/Province
Gangseo-Gu
ZIP/Postal Code
07795
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Evaluate the Safety and Immunogenecity of LBVE(Multivalent Pneumococcal Conjugate Vaccine) in Healthy Infants
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