A Study to Evaluate the Safety and Immunogenecity of LBVE(Multivalent Pneumococcal Conjugate Vaccine) in Healthy Infants

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03467984
• Other study ID #: LG-VECL002
• Status: Completed
• Phase: Phase 2
• Start date: May 25, 2018
• Est. completion date: March 27, 2019

Study information

• Verified date: August 2019
• Source: LG Chem
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and immunogenicity of LBVE (Multivalent Pneumococcal Conjugate Vaccine) in healthy infants.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Pneumococcal Infection
• Pneumococcal Infections

Intervention

Biological:
• LBVE
Multivalent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh
• Prevnar13
13-valent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh

Locations

Country	Name	City	State
Korea, Republic of	LG chem	Seoul	Gangseo-Gu

Sponsors (1)

Lead Sponsor	Collaborator
LG Chem

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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