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Immunogenicity and Safety Study of NBP606 in Healthy Infants

NCT02201030 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 577

Last updated 2020-04-20

No results posted yet for this study

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.

Conditions

  • Pneumococcal Infections

Interventions

BIOLOGICAL

NBP606

A single intramuscular injection into the thigh

BIOLOGICAL

Prevnar13

A single intramuscular injection into the thigh

Sponsors & Collaborators

  • SK Chemicals Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Confidential Investigator · Clinical Research Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
42 Days
Max Age
98 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-09-06
Primary Completion
2016-10-21
Completion
2016-10-21

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02201030 on ClinicalTrials.gov