Immunogenicity and Safety Study of NBP606 in Healthy Toddlers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

462 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-04

Study Completion Date

2017-10-26

Brief Summary

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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.

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Detailed Description

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Conditions

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Pneumococcal Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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NBP606

13-valent pneumococcal conjugate vaccine

Group Type EXPERIMENTAL

NBP606

Intervention Type BIOLOGICAL

A single intramuscular injection into the thigh

Prevnar13

13-valent pneumococcal conjugate vaccine

Group Type ACTIVE_COMPARATOR

Prevnar13

Intervention Type BIOLOGICAL

A single intramuscular injection into the thigh

Interventions

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NBP606

A single intramuscular injection into the thigh

Intervention Type BIOLOGICAL

Prevnar13

A single intramuscular injection into the thigh

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

12 Months

Maximum Eligible Age

15 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes