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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03467984
Recruitment Status : Completed
First Posted : March 16, 2018
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
LG Chem

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

Condition or disease Intervention/treatment Phase
Pneumococcal Infection Biological: LBVE Biological: Prevnar13 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official 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 LBVE(Multivalent Pneumococcal Conjugate Vaccine) Compared to Prevnar13 in Healthy Infants
Actual Study Start Date : May 25, 2018
Actual Primary Completion Date : October 5, 2018
Actual Study Completion Date : March 27, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


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

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

Eligibility Criteria
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Ages Eligible for Study:   6 Weeks to 8 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03467984


Locations
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Korea, Republic of
LG chem
Seoul, Gangseo-Gu, Korea, Republic of, 07795
Sponsors and Collaborators
LG Chem
More Information
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Responsible Party: LG Chem
ClinicalTrials.gov Identifier: NCT03467984    
Other Study ID Numbers: LG-VECL002
First Posted: March 16, 2018    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
 Infections
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs