Immunogenicity and Safety Study of NBP606 in Healthy Todd... | NCT02927444

Studies
Immunogenicity and Safety Study of NBP606 in Healthy Toddlers

NCT02927444

Sponsor

SK Chemicals Co., Ltd.

Status

Completed

Last Update Posted

Apr 20, 2020Actual

Enrollment

462Actual

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 2017

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

Nov 4, 2015Actual

Primary Completion Date

Oct 26, 2017Actual

Completion Date

Oct 26, 2017Actual

First Submitted Date

Oct 6, 2016

First Submission Date that Met QC Criteria

Oct 6, 2016

First Posted Date

Oct 7, 2016Estimated

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

Description Module

Brief Summary

This study will assess the immunogenicity and safety of booster 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

462Actual

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 booster vaccination

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy infants who completed 3 doses of primary vaccination (NBP606_PCVI_III_2013), available for follow-ups during the study period.
The LAR (Legally Authorized Representative) who understand the requirements of the study and voluntarily consent to participate in the study.

Exclusion Criteria:

Administration of other vaccines, except the ones provided in this study, within 1month prior to booster study
Known hypersensitivity to any components of the pneumococcal vaccine
Any confirmed or suspected immunosuppressive or immunodeficient conditions
Coagulation disorder contraindicating IM(intramuscular) vaccination
Participation to another study

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Months

Maximum Age

15 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Research Center		Seoul			South Korea

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