Pneumococcal Infection Clinical Trial
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
Verified date | August 2019 |
Source | LG Chem |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the safety and immunogenicity of LBVE (Multivalent Pneumococcal Conjugate Vaccine) in healthy infants.
Status | Completed |
Enrollment | 230 |
Est. completion date | March 27, 2019 |
Est. primary completion date | October 5, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Weeks to 8 Weeks |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | LG chem | Seoul | Gangseo-Gu |
Lead Sponsor | Collaborator |
---|---|
LG Chem |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of subjects achieving pneumococcal serotype-specific IgG >= 0.35 ug/ml | 4 weeks after 3rd(last) vaccination | ||
Primary | Pneumococcal serotype-specific IgG geometic mean concentration (GMC) ratios | 4 weeks after 3rd(last) vaccination | ||
Secondary | Proportion of subjects achieving targeted pneumococcal serotype-specific opsonophagocytic assay (OPA) titer | 4 weeks after 3rd(last) vaccination | ||
Secondary | Pneumococcal serotype-specific OPA geometic mean titer (GMT) ratios | 4 weeks after 3rd(last) vaccination | ||
Secondary | Solicited adverse events | Baseline(pre-vaccination) up to 7 days after each vaccination | ||
Secondary | Unsolicited adverse events | Baseline(pre-vaccination) up to 4 weeks after 3rd(last) vaccination |
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