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Completed

NCT Number: NCT03467984

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

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

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Key information

Conditions

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

Age range

6 week–8 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

LG chem

Seoul, Gangseo-Gu, 07795, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

LBVE

Biological

Multivalent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh

Prevnar13

Biological

13-valent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

LG Chem

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Mar 16, 2018
Registry last updated
Aug 22, 2019

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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