Back to resultsImmunogenicity and Safety Study of NBP606 in Healthy Infants
Primary Purpose
Pneumococcal Infections
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
NBP606
Prevnar13
Sponsored by
About this trial
This is an interventional prevention trial for Pneumococcal Infections
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
Sites / Locations
- Confidential
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
NBP606
Prevnar13
Arm Description
13-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine
Outcomes
Primary Outcome Measures
Proportion of subjects with the targeted antibody concentration
Secondary Outcome Measures
Geometric mean concentration ratio
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02201030
Brief Title
Immunogenicity and Safety Study of NBP606 in Healthy Infants
Official Title
Multi-Center, Randomized, Double-Blind, Phase III Trial to Assess the Immunogenicity and Safety of Primary Vaccination With NBP606 in Healthy Infants
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
September 6, 2014 (Actual)
Primary Completion Date
October 21, 2016 (Actual)
Study Completion Date
October 21, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SK Chemicals Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumococcal Infections
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
577 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NBP606
Arm Type
Experimental
Arm Description
13-valent pneumococcal conjugate vaccine
Arm Title
Prevnar13
Arm Type
Active Comparator
Arm Description
13-valent pneumococcal conjugate vaccine
Intervention Type
Biological
Intervention Name(s)
NBP606
Intervention Description
A single intramuscular injection into the thigh
Intervention Type
Biological
Intervention Name(s)
Prevnar13
Intervention Description
A single intramuscular injection into the thigh
Primary Outcome Measure Information:
Title
Proportion of subjects with the targeted antibody concentration
Time Frame
1 month after the primary vaccination
Secondary Outcome Measure Information:
Title
Geometric mean concentration ratio
Time Frame
1 month after the primary vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
42 Days
Maximum Age & Unit of Time
98 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Confidential Investigator
Organizational Affiliation
Clinical Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Confidential
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Immunogenicity and Safety Study of NBP606 in Healthy Infants
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