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Completed

NCT Number: NCT02201030

Immunogenicity and Safety Study of NBP606 in Healthy Infants

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.

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Key information

Conditions

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

Age range

42 day–98 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Confidential

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 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

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 primary vaccination

Secondary outcomes

  1. Geometric mean concentration ratio

    Time frame: 1 month after the primary 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 Primary Vaccination With NBP606 in Healthy Infants

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 25, 2014
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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