Back to resultsImmunogenicity and Safety Study of NBP606 in Healthy Toddlers
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 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
Sites / Locations
- Clinical Research Center
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
NCT02927444
Brief Title
Immunogenicity and Safety Study of NBP606 in Healthy Toddlers
Official Title
Multi-Center, Randomized, Double-Blind, Phase III Trial to Assess the Immunogenicity and Safety of Booster Vaccination With NBP606 in Healthy Toddlers (The Extension Study of NBP606_PCVI_III_2013)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
November 4, 2015 (Actual)
Primary Completion Date
October 26, 2017 (Actual)
Study Completion Date
October 26, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SK Chemicals Co., Ltd.
4. Oversight
5. Study Description
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.
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
462 (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 booster vaccination
Secondary Outcome Measure Information:
Title
Geometric mean concentration ratio
Time Frame
1 month after the booster vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
15 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Clinical Research Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Immunogenicity and Safety Study of NBP606 in Healthy Toddlers
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