Immunogenicity and Safety Study of NBP606 in Healthy Infants

SK chemicals

Status and phase: Completed; Phase 3

Conditions: Pneumococcal Infections

Treatments: Biological: NBP606; Biological: Prevnar13

Study type: Interventional

Funder types: Industry

Identifiers

NCT02201030

NBP606_PCVI_III_2013

Details and patient eligibility

About

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.

Enrollment: 577 patients

Sex: All

Ages: 42 to 98 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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577 participants in 2 patient groups

NBP606

Experimental group

Description:

13-valent pneumococcal conjugate vaccine

Treatment:

Biological: NBP606

Prevnar13

Active Comparator group

Description:

13-valent pneumococcal conjugate vaccine

Treatment:

Biological: Prevnar13