NCT02927444

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
462

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 4, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 7, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2017

Completed
Last Updated

April 20, 2020

Status Verified

October 1, 2017

Enrollment Period

2 years

First QC Date

October 6, 2016

Last Update Submit

April 17, 2020

Conditions

Pneumococcal Infections

Outcome Measures

Primary Outcomes (1)

  • Proportion of subjects with the targeted antibody concentration

    1 month after the booster vaccination

Secondary Outcomes (1)

  • Geometric mean concentration ratio

    1 month after the booster vaccination

Study Arms (2)

NBP606

EXPERIMENTAL

13-valent pneumococcal conjugate vaccine

Biological: NBP606

Prevnar13

ACTIVE COMPARATOR

13-valent pneumococcal conjugate vaccine

Biological: Prevnar13

Interventions

NBP606BIOLOGICAL

A single intramuscular injection into the thigh

NBP606
Prevnar13BIOLOGICAL

A single intramuscular injection into the thigh

Prevnar13

Eligibility Criteria

Age12 Months - 15 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Pneumococcal Infections

Condition Hierarchy (Ancestors)

Streptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2016

First Posted

October 7, 2016

Study Start

November 4, 2015

Primary Completion

October 26, 2017

Study Completion

October 26, 2017

Last Updated

April 20, 2020

Record last verified: 2017-10

Locations

KR(1)