A Randomized, Double blind, Active controlled, Phase 2 Clinical Trial to Assess the Immunogenicity and Safety of GBP411 in Healthy Infants

Phase 2

• Conditions: Pneumococcal Infections; Immunologic Factors; Streptococcal Infections; Gram- Positive Bacterial Infections; Physiological Effects of Drugs; Bacterial Infections

• Registration Number: TCTR20170109002
• Lead Sponsor: SK Chemicals, Co. Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-09
• Study Completion: 2018-04-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

-Healthy Infants between 6 and 10 weeks of age (approximately 1.5 months) at the time of enrollment.
-The LAR (Legally Authorized Representative) who understand the requirements of the study and voluntarily consent to participate in the study.

Exclusion Criteria

-Known hypersensitivity to any components of the pneumococcal vaccine
-Any confirmed or suspected immunosuppressive or immunodeficient conditions
-Coagulation disorder contraindicating IM(intramuscular) vaccination
-Subject has received any licensed vaccine(not including BCG and Hepatitis B)
-Participation to another study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of subjects with the targeted antibody concentration 1 month after the primary vaccination enzyme linked immunosorbent assay (ELISA)

Secondary Outcome Measures

Name	Time	Method
Geometric mean concentration ratio 1 month after the booster vaccination enzyme linked immunosorbent assay (ELISA)