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

NCT ID: NCT03467984

Last Updated: 2019-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-25

Study Completion Date

2019-03-27

Brief Summary

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

Detailed Description

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Conditions

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Pneumococcal Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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LBVE

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

Group Type EXPERIMENTAL

LBVE

Intervention Type BIOLOGICAL

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

Prevnar13

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

Group Type ACTIVE_COMPARATOR

Prevnar13

Intervention Type BIOLOGICAL

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

Interventions

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LBVE

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

Intervention Type BIOLOGICAL

Prevnar13

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

6 Weeks

Maximum Eligible Age

8 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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LG Chem

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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LG chem

Seoul, Gangseo-Gu, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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LG-VECL002

Identifier Type: -

Identifier Source: org_study_id

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