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OpenTrials
Completed

NCT Number: NCT02927444

Immunogenicity and Safety Study of NBP606 in Healthy Toddlers

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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Key information

Conditions

Pneumococcal Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Streptococcal Infections

Age range

12 month–15 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinical Research Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NBP606

Biological

A single intramuscular injection into the thigh

Prevnar13

Biological

A single intramuscular injection into the thigh

Primary outcomes

  1. Proportion of subjects with the targeted antibody concentration

    Time frame: 1 month after the booster vaccination

Secondary outcomes

  1. Geometric mean concentration ratio

    Time frame: 1 month after the booster vaccination

Sponsors and collaborators

Lead sponsor

SK Chemicals Co., Ltd.

Industry

Registry information

Official study title

Multi-Center, Randomized, Double-Blind, Phase III Trial to Assess the Immunogenicity and Safety of Booster Vaccination With NBP606 in Healthy Toddlers (The Extension Study of NBP606_PCVI_III_2013)

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 7, 2016
Registry last updated
Apr 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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