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

August 21, 2019 updated by: LG Chem

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

230

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 1 month (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LBVE
Infants will receive a 0.5mL intramuscular injection of LBVE at 6,10 and 14 weeks of age
Biological: LBVE
Multivalent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh
Active Comparator: Prevnar13
Infants will receive a 0.5mL intramuscular injection of Prevnar13 at 6,10 and 14 weeks of age
Biological: Prevnar13
13-valent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects achieving pneumococcal serotype-specific IgG >= 0.35 ug/ml
Time Frame: 4 weeks after 3rd(last) vaccination
4 weeks after 3rd(last) vaccination
Pneumococcal serotype-specific IgG geometic mean concentration (GMC) ratios
Time Frame: 4 weeks after 3rd(last) vaccination
4 weeks after 3rd(last) vaccination

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects achieving targeted pneumococcal serotype-specific opsonophagocytic assay (OPA) titer
Time Frame: 4 weeks after 3rd(last) vaccination
4 weeks after 3rd(last) vaccination
Pneumococcal serotype-specific OPA geometic mean titer (GMT) ratios
Time Frame: 4 weeks after 3rd(last) vaccination
4 weeks after 3rd(last) vaccination
Solicited adverse events
Time Frame: Baseline(pre-vaccination) up to 7 days after each vaccination
Baseline(pre-vaccination) up to 7 days after each vaccination
Unsolicited adverse events
Time Frame: Baseline(pre-vaccination) up to 4 weeks after 3rd(last) vaccination
Baseline(pre-vaccination) up to 4 weeks after 3rd(last) vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LG Chem

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2018

Primary Completion (Actual)

October 5, 2018

Study Completion (Actual)

March 27, 2019

Study Registration Dates

First Submitted

March 12, 2018

First Submitted That Met QC Criteria

March 15, 2018

First Posted (Actual)

March 16, 2018

Study Record Updates

Last Update Posted (Actual)

August 22, 2019

Last Update Submitted That Met QC Criteria

August 21, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LG-VECL002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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