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NCT02927444 Clinical Trial

Immunogenicity and Safety Study of NBP606 in Healthy Toddlers

Pneumococcal Infections Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02927444
Other study ID # NBP606_PCVT_III_2013
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date November 4, 2015
Est. completion date October 26, 2017

Study information
Verified date October 2017
Source SK Chemicals Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 462
Est. completion date October 26, 2017
Est. primary completion date October 26, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Months to 15 Months
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• NBP606
A single intramuscular injection into the thigh
• Prevnar13
A single intramuscular injection into the thigh

Locations
Country Name City State
Korea, Republic of Clinical Research Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
SK Chemicals Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of subjects with the targeted antibody concentration 1 month after the booster vaccination
Secondary Geometric mean concentration ratio 1 month after the booster vaccination
See also
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