ClinicalTrials.gov
ClinicalTrials.gov Menu

Immunogenicity and Safety Study of NBP606 in Healthy Toddlers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02927444
Recruitment Status : Unknown
Verified October 2016 by SK Chemicals Co.,Ltd..
Recruitment status was:  Recruiting
First Posted : October 7, 2016
Last Update Posted : October 7, 2016
Sponsor:
Information provided by (Responsible Party):
SK Chemicals Co.,Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pneumococcal Infections Biological: NBP606 Biological: Prevnar13 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 534 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official 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)
Study Start Date : October 2015
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NBP606
13-valent pneumococcal conjugate vaccine
Biological: NBP606
A single intramuscular injection into the thigh

Active Comparator: Prevnar13
13-valent pneumococcal conjugate vaccine
Biological: Prevnar13
A single intramuscular injection into the thigh




Primary Outcome Measures :
  1. Proportion of subjects with the targeted antibody concentration [ Time Frame: 1 month after the booster vaccination ]

Secondary Outcome Measures :
  1. Geometric mean concentration ratio [ Time Frame: 1 month after the booster vaccination ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Months to 15 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02927444


Contacts
Contact: Confidential Investigator, Dr +82-000-0000

Locations
Korea, Republic of
Clinical Research Center Recruiting
Seoul, Korea, Republic of
Contact: Principle Investigator         
Sponsors and Collaborators
SK Chemicals Co.,Ltd.

Responsible Party: SK Chemicals Co.,Ltd.
ClinicalTrials.gov Identifier: NCT02927444     History of Changes
Other Study ID Numbers: NBP606_PCVT_III_2013
First Posted: October 7, 2016    Key Record Dates
Last Update Posted: October 7, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs