A study to determine the safety and immunogenicity of a new Pneumococcal vaccine in healthy infants

Registry ID

PHRR180205-001789

Secondary Identification Number

LG-VECL002

FDA Clinical Trial Reference (CTR) Number

2017-CT0428

Scientific 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 LBVE014 (Pneumococcal 14-valent conjugate vaccine [diphtheria CRM197 protein]) compared to Prevnar13 in healthy infants

Project Description

This study is a single-blind, multi-center, randomized, active-controlled, parallel group, phase II study designed to evaluate the safety and immunogenicity of LBVE compared with Prevnar13 given with 3 doses vaccinations in healthy infants.

NUHRA Details

Regime	Classification	Priority
2010 - 2016	Health Technology Development	Drug Discovery and Development

Project Duration

Start Date	Duration in Months	Target Completion Date	Actual Completion Date
2018-02-19	13	2019-03-19	0000-00-00

Project Status

Completed

Implementing Agency (Primary Sponsor)

Institution	Classification	Region	LTO #
LG Life Sciences, Ltd.	Private Business	South Korea	N/A

Cooperating Agency (Secondary Sponsor)

Institution	Classification	Region	LTO #
INC Research Pte. Ltd.	Private Business	NCR	LTO-3000001893279

Funding Agency (Sources of Monetary or Material Support)

Institution	Region
LG Chem, Ltd.	South Korea

Contact for Public Queries

Name	E-Mail	Institution and Institution Address
Younghwan Jang	younghj@lgchem.com	E14 Block, LG Science Park, 70, Magokjungang 10-ro, Gangseo-gu, Seoul, 07795, Republic of Korea

Contact for Scientific Queries

Name	E-Mail	Institution and Institution Address
Younghwan Jang	younghj@lgchem.com	E14 Block, LG Science Park, 70, Magokjungang 10-ro, Gangseo-gu, Seoul, 07795, Republic of Korea

Investigating Team

Name	Expertise	Affiliation
Grace Devota G. Go, MD	Pediatrics	Mary Chiles General Hospital
Maria Rosario Z. Capeding, MD	Pediatrics	Research Institute for Tropical Medicine

Project Location and Institutional Ethics Review Board

Project Location	Institutional Ethics Review Board
Mary Chiles General Hospital	Mary Chiles General Hospital Ethics Review Committee
Research Institute for Tropical Medicine	Research Institute for Tropical Medicine Institutional Review Board

Health Condition(s) or Problem(s) Studied

Active immunization in infants against pneumococcal diseases

Primary Outcomes

To evaluate the safety and immunogenicity of LBVE compared with Prevnar13 when administered to healthy infants at 6, 10 and 14 weeks of age.

Key Secondary Outcomes

Unspecified

Recruitment Status

Pending

Countries of Recruitment

Philippines

Research Classification

Clinical Trial

FDA Document Tracking Number

20171003101127

FDA Approval Date

2017-12-15

ERC Approval Date

0000-00-00

Target Sample Size (Philippines)

230

Actual Sample Size (Philippines)

Unspecified

Reason for the difference between Target & Actual Sample Sizes

Unspecified

Date of First Enrolment

2018-02-19

Key Inclusion and Exlusion Criteria (CT)

INCLUSION:

1) 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

2) Born at full term of pregnancy (Gestational age >37 weeks)

3) Body weight > 3.2 kg at the time of enrollment

4) Born to HIV negative mother

5) The parents or Legally Acceptable Representative (LAR) able to understand and comply with planned study procedures

6) Signed informed consent by subject’s parents or Legally Acceptable Representative (LAR)

EXCLUSION:

1) Previously received any pneumococcal vaccine

2) History of previous vaccinations other than and BCG (Bacillus Calmette-Guerin), hepatitis B, Hib, diphtheria, tetanus, pertussis, polio (OPV and IPV) and rotavirus

3) History of bleeding disorder that might contraindicate intramuscular injection

4) Experienced fever > 38.0°C/ 100.4°F within the past 3 days

5) Receipt of immunoglobulin or blood-derived product before the study

6) History of allergy reactions to any vaccine component, including excipients and preservatives

7) Known or suspected immune disorder, or received immunosuppressive therapy

8) History of invasive diseases, acute otitis media or pneumonia caused by Streptococcus pneumoniae

9) History of any neurologic disorders or seizures

10) Known major congenital malformation or serious chronic disorder

11) Participation in another interventional trial or received any investigational product 30 days prior to enrollment or simultaneous participation in another clinical study

12) Infants whose families are planning to leave the area of the study site before the end of the study period

13) Infants who are considered unsuitable for the clinical study by the investigator

Study Type

Interventional

Intervention Name

LBVE

Intervention Description

Test vaccine - LBVE

Comparator - Prevnar13

The test vaccine or comparator is administered through intramuscular three injections at the visit 1(screening), visit 2, and visit 3.

Amendment Approval Date/Reasons

None

Method of Allocation

Randomized

Masking / Blinding

Single Blind

Masking Details

This clinical study is a single-blind study and tries to maintain the objectivity of the study results by only preventing the subject’s parent or LAR from knowing whether their infants receive the test vaccine or comparator. In order to maintain the single-blind, the subjects are administered study vaccines in a separate room without subject’s parent or LAR to prevent them from knowing which study vaccines subjects receive. Therefore, to which study group a subject is assigned is known to the responsible person who prepared the randomization code, code manager, clinical trial pharmacist, and the related personnel including the investigator except subjects.

Assignment

Parallel

Purpose

The primary purpose of this clinical study is to evaluate the safety of the intramuscular the three injections with test vaccine (LBVE), and to assess the immunogenicity of the test vaccine (LBVE) by measuring the IgG concentration and functional antibody titer using ELISA and OPA.

Phase

Phase II

Research Utilization

Utilization	Utilization Info
Publication
Oral Presentation
Drug Literature
Posters
Others