Immunogenicity and Safety Study of NBP606 in Healthy Infants

April 17, 2020 updated by: SK Chemicals Co., Ltd.

Multi-Center, Randomized, Double-Blind, Phase III Trial to Assess the Immunogenicity and Safety of Primary Vaccination With NBP606 in Healthy Infants

This study will assess the immunogenicity and safety of primary vaccination with NBP606 compared to the existing commercial vaccine, when given concomitantly with routine pediatric vaccinations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

577

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 3 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy Infants between 42 and 98 days of age (approximately 2 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Prevnar13
13-valent pneumococcal conjugate vaccine
Biological: Prevnar13
A single intramuscular injection into the thigh
Experimental: NBP606
13-valent pneumococcal conjugate vaccine
Biological: NBP606
A single intramuscular injection into the thigh

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects with the targeted antibody concentration
Time Frame: 1 month after the primary vaccination
1 month after the primary vaccination

Secondary Outcome Measures

Outcome Measure
Time Frame
Geometric mean concentration ratio
Time Frame: 1 month after the primary vaccination
1 month after the primary vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SK Chemicals Co., Ltd.

Investigators

  • Principal Investigator: Confidential Investigator, Clinical Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2014

Primary Completion (Actual)

October 21, 2016

Study Completion (Actual)

October 21, 2016

Study Registration Dates

First Submitted

July 16, 2014

First Submitted That Met QC Criteria

July 23, 2014

First Posted (Estimate)

July 25, 2014

Study Record Updates

Last Update Posted (Actual)

April 20, 2020

Last Update Submitted That Met QC Criteria

April 17, 2020

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NBP606_PCVI_III_2013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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