Immunogenicity and Safety Study of NBP606 in Healthy Infants

Phase 3CompletedNCT02201030

SK Chemicals Co., Ltd.577 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

577

Conditions

Pneumococcal Infections

Interventions

NBP606BIOLOGICAL

A single intramuscular injection into the thigh

Prevnar13BIOLOGICAL

A single intramuscular injection into the thigh

Eligibility

Sex: ALLMin age: 42 DaysMax age: 98 DaysHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Confidential

Seoul, South Korea

Outcomes

Primary Outcomes

Proportion of subjects with the targeted antibody concentration

Time frame: 1 month after the primary vaccination

Secondary Outcomes

Geometric mean concentration ratio

Time frame: 1 month after the primary vaccination

Data from ClinicalTrials.gov

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