Immunogenicity and Safety Study of NBP606 in Healthy Infants | NCT02201030

Studies
Immunogenicity and Safety Study of NBP606 in Healthy Infants

NCT02201030

Sponsor

SK Chemicals Co., Ltd.

Status

Completed

Last Update Posted

Apr 20, 2020Actual

Enrollment

577Actual

Phase

Phase 3

Conditions

Pneumococcal Infections

Interventions

NBP606
Prevnar13

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 6, 2014Actual

Primary Completion Date

Oct 21, 2016Actual

Completion Date

Oct 21, 2016Actual

First Submitted Date

Jul 16, 2014

First Submission Date that Met QC Criteria

Jul 23, 2014

First Posted Date

Jul 25, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 17, 2020

Last Update Posted Date

Apr 20, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

577Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NBP606	Experimental	13-valent pneumococcal conjugate vaccine	Biological: NBP606
Prevnar13	Active Comparator	13-valent pneumococcal conjugate vaccine	Biological: Prevnar13

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NBP606	Biological	A single intramuscular injection into the thigh	NBP606

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

42 Days

Maximum Age

98 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Confidential Investigator	Clinical Research Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Confidential		Seoul			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011008	Pneumococcal Infections

Ancestor Terms

ID	Term
D013290	Streptococcal Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses

Browse Leaves

Not provided

Browse Branches

Not provided