A Study to Evaluate the Safety and Immunogenecity of LBVE(Multivalent Pneumococcal Conjugate Vaccine) in Healthy Infants
Phase 2
Completed
- Conditions
- Pneumococcal Infection
- Registration Number
- NCT03467984
- Lead Sponsor
- LG Chem
- Brief Summary
The purpose of this study is to evaluate the safety and immunogenicity of LBVE (Multivalent Pneumococcal Conjugate Vaccine) in healthy infants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 230
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Proportion of subjects achieving targeted pneumococcal serotype-specific opsonophagocytic assay (OPA) titer 4 weeks after 3rd(last) vaccination Unsolicited adverse events Baseline(pre-vaccination) up to 4 weeks after 3rd(last) vaccination Solicited adverse events Baseline(pre-vaccination) up to 7 days after each vaccination Pneumococcal serotype-specific OPA geometic mean titer (GMT) ratios 4 weeks after 3rd(last) vaccination
Trial Locations
- Locations (1)
LG chem
🇰🇷Seoul, Gangseo-Gu, Korea, Republic of
LG chem🇰🇷Seoul, Gangseo-Gu, Korea, Republic of