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

LG Chem

Status and phase: Completed; Phase 2

Conditions: Pneumococcal Infection

Treatments: Biological: Prevnar13; Biological: LBVE

Study type: Interventional

Funder types: Industry

Identifiers

NCT03467984

LG-VECL002

Details and patient eligibility

About

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

Enrollment: 230 patients

Sex: All

Ages: 6 to 8 weeks old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

230 participants in 2 patient groups

LBVE

Experimental group

Description:

Infants will receive a 0.5mL intramuscular injection of LBVE at 6,10 and 14 weeks of age

Treatment:

Biological: LBVE

Prevnar13

Active Comparator group

Description:

Infants will receive a 0.5mL intramuscular injection of Prevnar13 at 6,10 and 14 weeks of age

Treatment:

Biological: Prevnar13