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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03467984

Enrollment

230

Registered

2018-03-16

Start date

2018-05-25

Completion date

2019-03-27

Last updated

2019-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumococcal Infection

Brief summary

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

Interventions

BIOLOGICALLBVE

Multivalent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh

BIOLOGICALPrevnar13

13-valent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

6 Weeks to 8 Weeks

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026