Immunogenicity and Safety Study of NBP606 in Healthy Toddlers

SK chemicals

Status and phase: Completed; Phase 3

Conditions: Pneumococcal Infections

Treatments: Biological: Prevnar13; Biological: NBP606

Study type: Interventional

Funder types: Industry

Identifiers

NCT02927444

NBP606_PCVT_III_2013

Details and patient eligibility

About

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.

Enrollment: 462 patients

Sex: All

Ages: 12 to 15 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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462 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