A Study to Evaluate the Safety and Immunogenecity of LBVE(Multivalent Pneumococcal Conjugate Vaccine) in Healthy Infants
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
1 other identifier
interventional
230
1 country
1
Brief Summary
The purpose of this study is to evaluate the safety and immunogenicity of LBVE (Multivalent Pneumococcal Conjugate Vaccine) in healthy infants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2018
Shorter than P25 for phase_2
1 active site
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
March 12, 2018
CompletedFirst Posted
Study publicly available on registry
March 16, 2018
CompletedStudy Start
First participant enrolled
May 25, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 5, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 27, 2019
CompletedAugust 22, 2019
August 1, 2019
4 months
March 12, 2018
August 21, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Proportion of subjects achieving pneumococcal serotype-specific IgG >= 0.35 ug/ml
4 weeks after 3rd(last) vaccination
Pneumococcal serotype-specific IgG geometic mean concentration (GMC) ratios
4 weeks after 3rd(last) vaccination
Secondary Outcomes (4)
Proportion of subjects achieving targeted pneumococcal serotype-specific opsonophagocytic assay (OPA) titer
4 weeks after 3rd(last) vaccination
Pneumococcal serotype-specific OPA geometic mean titer (GMT) ratios
4 weeks after 3rd(last) vaccination
Solicited adverse events
Baseline(pre-vaccination) up to 7 days after each vaccination
Unsolicited adverse events
Baseline(pre-vaccination) up to 4 weeks after 3rd(last) vaccination
Study Arms (2)
LBVE
EXPERIMENTALInfants will receive a 0.5mL intramuscular injection of LBVE at 6,10 and 14 weeks of age
Prevnar13
ACTIVE COMPARATORInfants will receive a 0.5mL intramuscular injection of Prevnar13 at 6,10 and 14 weeks of age
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LG Chemlead
Study Sites (1)
LG chem
Seoul, Gangseo-Gu, 07795, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2018
First Posted
March 16, 2018
Study Start
May 25, 2018
Primary Completion
October 5, 2018
Study Completion
March 27, 2019
Last Updated
August 22, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share