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Completed

NCT Number: NCT02892812

A Phase I Clinical Trial of a 13-valent Pneumococcal Conjugate Vaccine and 14-valent Pneumococcal Conjugate Vaccine in Adults

The purpose of this study is to evaluate the safety and immunogenicity of LBVE013 (Pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]) or LBVE014 (Pneumococcal 14-valent conjugate vaccine [diphtheria CRM197 protein]) in healthy adults.

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Key information

Conditions

Pneumococcal Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Streptococcal Infections

Age range

19 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy adult older than 19 years old and younger than 50 years old
  • A subject who was informed of the purpose, method, and efficacy of the clinical study and signed the written informed consent form

Exclusion criteria

  • A subject who participated in other clinical studies within 3 months before screening
  • A subject who was vaccinated with other vaccines within 4 weeks before screening, or who is expected to receive other vaccination during the clinical study period
  • A subject with medical history of hypersensitive reactions (e.g. anaphylaxis) to the test drug or its ingredients
  • A subject who received immunoglobulin or blood-derived materials within 3 months before screening
  • A subject with immunologic function disorders including congenital or acquired immunodeficiency disorders
  • A subject who is receiving immunosuppressive therapy or drugs that can affect immunological reaction
  • A subject with pyrexia of over 38 Celsius degrees on the day of the vaccination with the investigational products
  • A subject with medical history of Invasive Pneumococcal Disease (IPD) or pneumonia caused by Streptococcus pneumoniae
  • A subject who was vaccinated with any pneumococcal vaccine before screening
  • A subject who received the vaccine containing diphtheria toxoid within 6 months before screening (e.g. adult Td vaccine)

Treatment and study plan

pneumococcal conjugate vaccine

Biological

Primary outcomes

  1. Solicited adverse events

    Time frame: Baseline(pre-vaccination) up to 7 days after vaccination

  2. Unsolicited adverse events

    Time frame: Baseline(pre-vaccination) up to 4 weeks after vaccination

  3. Immediate reactions after vaccination

    Time frame: Baseline(pre-vaccination) up to 30 minutes after vaccination

Secondary outcomes

  1. Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 4 weeks After Vaccination

    Time frame: 4 weeks after vaccination

  2. Proportion of subjects achieving 4-fold rise in Pneumococcal Opsonophagocytic Activity (OPA) titer at 4 weeks after vaccination

    Time frame: 4 weeks after vaccination

  3. Serotype-Specific Pneumococcal IgG antibody Geometric Mean Concentrations (GMCs) 4 weeks After Vaccination

    Time frame: 4 weeks after vaccination

Sponsors and collaborators

Lead sponsor

LG Life Sciences

Industry

Registry information

Official study title

A Single-blind, Single-center, Randomized, Active-controlled, Parallel Group, Phase I Study to Evaluate the Safety and Immunogenicity of Intramuscular Single Injection With LBVE013 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), LBVE014 (Pneumococcal 14-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) or Prevnar13 in Healthy Adults

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Sep 8, 2016
Registry last updated
Jun 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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