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A Multi-national, Multi-center, Randomized, Double-Blind, Active-Controlled, Phase III Study to Investigate the Efficacy and Safety of 'GC3107 (BCG Vaccine)' after Intradermal Administration in Healthy Infants

PHRR210624-003680

Unspecified

2021-CT0597

A Multi-national, Multi-center, Randomized, Double-Blind, Active-Controlled, Phase III Study to Investigate the Efficacy and Safety of 'GC3107 (BCG Vaccine)' after Intradermal Administration in Healthy Infants

This is a Phase III randomized, multi-center, double-blind, active-controlled clinical trial to assess the efficacy and safety of the lyophilized Bacillus Calmette-Guerin (BCG) vaccine in healthy infants. 

Regime Classification Priority
2017 - 2022 Research to enhance and extend healthy lives Access to essential medical products, vaccines and technologies
Start Date Duration in Months Target Completion Date Actual Completion Date
2021-09-01 10 2022-07-01 0000-00-00

Ongoing

Institution Classification Region LTO #
Green Cross Corp. Private Business South Korea
Institution Region
Green Cross Corp. South Korea
Name E-Mail Institution and Institution Address
Charles Anthony Suarez regulatory@pivot-cro.com Pi Health Inc. at 6F Rockwell Business Center Tower 3, Ortigas Avenue Pasig City, 1604 Philippines
Name E-Mail Institution and Institution Address
Charles Anthony Suarez regulatory@pivot-cro.com Pi Health Inc. at 6F Rockwell Business Center Tower 3, Ortigas Avenue Pasig City, 1604 Philippines
Name Expertise Affiliation
Lulu C. Bravo, MD Pediatrics National Institutes of Health - University of the Philippines - Manila
Maria Isabel M Atienza Pediatrics St. Luke's Medical Center - Quezon City
Maria Rosario Z. Capeding, MD Pediatrics Tropical Disease Foundation, Inc.
Project Location Institutional Ethics Review Board
National Institutes of Health - University of the Philippines - Manila National Institutes of Health
St. Luke's Medical Center - Quezon City St. Luke's Medical Center Institutional Ethics Review Board
Tropical Disease Foundation, Inc. Tropical Disease Foundation Institutional Review Board

Tuberculosis prevention

Proportion of subjects with maximum diameter of induration ≥5 mm in the tuberculin skin test performed 84 days after administration of the investigational product (PPD response rate)

1) Mean maximum diameter (mm) of induration in the tuberculin skin test performed 84 days after administration of the investigational product
2) Proportion of subjects with maximum diameter of induration

3) Proportion of subjects with maximum diameter of erythema ≥5 mm in the tuberculin skin test performed 84 days after administration of the investigational product
4) Mean maximum diameter (mm) of erythema in the tuberculin skin test performed 84 days after administration of the investigational product
5) Proportion of subjects with maximum diameter of erythema

Pending

  • Philippines

Clinical Trial

Unspecified

20210216130845

2021-04-23

0000-00-00

280

Unspecified

Unspecified

2021-09-01

Inclusion Criteria

1) Subject's legally acceptable representatives had this clinical trial information explained to them and understood it, voluntarily decided participation, and provided informed consent

2) Healthy infants aged ≤ 4 weeks
3) Body weight ≥2,500 g at birth
4) Born after normal gestation (≥37 weeks)

 

Exclusion Criteria

1) Had contact with patients with a confirmed diagnosis of active pulmonary tuberculosis
2) Any symptoms or signs of active tuberculosis infection or current treatment of tuberculosis at screening (Visit 1)
3) History of confirmed tuberculosis
4) Acute fever with tympanic temperature ≥38.0 ℃ within 24 hours prior to administration of the investigational product, or an active infectious disease at screening (Visit 1) (However, subjects with tympanic temperature ≥38.0 ℃ within 24 hours prior to administration of the investigational product may be rescreened only once,
and subjects with mild acute diseases such as mild fever, mild respiratory infection, otitis media, and diarrhea may be permitted to be vaccinated at the judgment of the investigator.)
5) Hypothermia with tympanic temperature 6) Clinically suspected neonatal sepsis
7) Born with severe congenital anomaly that may affect the efficacy or safety result of this clinical trial as judged by the investigator
8) Severe skin disease or burn at the injection site of investigational product
9) The subject's mother had human immunodeficiency virus (HIV)-positive result from tests performed within the period from pregnancy through screening (Visit 1)
10) The subject’s mother received immune modifying drug, immunosuppressant, or TNF inhibitor during pregnancy or lactation
11) Known or suspected hypersensitivity to any components (including Lmonosodium glutamate) of the investigational product or purified protein derivative (PPD) reagent

12) Known immunodeficiency disease or incomplete immune function (i.e., hypogammaglobulinemia) or family history of immunodeficiency disease
13) Immunocompromised state due to immunosuppressant, anti-cancer drug or radiotherapy prior to screening (Visit 1), or prolonged use of systemic corticosteroids (prednisone equivalent dose of ≥2 mg/kg/day for body weight ≤10 kg, or prednisone equivalent dose of ≥20 mg/day for body weight >10 kg; Used continuously for ≥2 weeks. However, inhaled, intranasal or local administration of corticosteroids is permitted regardless of the dose used.)
14) History of other vaccines including BCG vaccine prior to screening (Visit 1), with an exception of Hepatitis B vaccine according to the national standard vaccination schedule
15) Participated in other clinical trial and received an investigational product prior to screening (Visit 1)
16) Ineligible to participate in the clinical trial based on other clinically significant medical findings, in the opinion of the investigator

 

 

Interventional

GC3017 (BCG Vaccine)

1mg/ml Lyophilized Powder for Intradermal Injectable Suspension

None

Randomized

Double Blind

Unspecified

Parallel

Double-Blind Randomized Study, Active-Controlled

Phase III

Utilization Utilization Info
Publication
Oral Presentation
Drug Literature
Posters
Others
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