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NCT02201030 Clinical Trial

Immunogenicity and Safety Study of NBP606 in Healthy Infants

Pneumococcal Infections Clinical Trial

Official title:
Multi-Center, Randomized, Double-Blind, Phase III Trial to Assess the Immunogenicity and Safety of Primary Vaccination With NBP606 in Healthy Infants

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02201030
Other study ID # NBP606_PCVI_III_2013
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date September 6, 2014
Est. completion date October 21, 2016

Study information
Verified date October 2016
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 primary vaccination with NBP606 compared to the existing commercial vaccine, when given concomitantly with routine pediatric vaccinations.

Recruitment information / eligibility
Status Completed
Enrollment 577
Est. completion date October 21, 2016
Est. primary completion date October 21, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 42 Days to 98 Days
Eligibility 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

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 Confidential 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 primary vaccination
Secondary Geometric mean concentration ratio 1 month after the primary vaccination
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