Submitted by: John Michael Dominic Go 2018-01-31 00:00:00 Last Updated by: John Michael Dominic Go 2018-02-06 15:41:37


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

PHRR180205-001789

LG-VECL002

2017-CT0428

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

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.

Regime Classification Priority
2010 - 2016 Health Technology Development Drug Discovery and Development
Start Date Duration in Months Target Completion Date Actual Completion Date
2018-02-19 13 2019-03-19 0000-00-00

Pending

Sites are yet to be initiated

Institution Classification Region LTO #
LG Life Sciences, Ltd. Private Business South Korea N/A
Institution Classification Region LTO #
INC Research Pte. Ltd. Private Business NCR LTO-3000001893279
Institution Region
LG Chem, Ltd. South Korea
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
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
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 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

Active immunization in infants against pneumococcal diseases

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

Unspecified

Pending

  • Philippines

Clinical Trial

LG-VECL002

20171003101127

2017-12-15

0000-00-00

230

Unspecified

Unspecified

19 Feb 2018

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

Interventional

LBVE

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.

None

Randomized

Single Blind

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.

Parallel

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 II

Utilization Utilization Info
No records found.

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