Study Stopped
The study was terminated during the EC submission process prior to the enrollment.
Safety and Immunogenicity of SCB-2019 in Children <18 Years of Age
A Randomized, Controlled, Dose-finding, Observer-blind, Phase 2/3 Study to Evaluate the Safety, Reactogenicity and Immunogenicity of CpG/Alum-adjuvanted Recombinant SARS-CoV-2 Trimeric S-protein Subunit Vaccines (SCB-2019 Vaccine) in Children <18 Years of Age
1 other identifier
interventional
N/A
1 country
2
Brief Summary
This is a phase 2/3, randomized, controlled study to assess the reactogenicity, safety and immunogenicity of adjuvanted recombinant SARS-CoV-2 trimeric S-protein subunit vaccine (SCB-2019), when administered as 2-dose vaccination series in children below 18 years of age.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2022
Shorter than P25 for phase_2 covid19
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 23, 2021
CompletedFirst Posted
Study publicly available on registry
January 14, 2022
CompletedStudy Start
First participant enrolled
October 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2022
CompletedMarch 24, 2023
March 1, 2023
2 months
December 23, 2021
March 22, 2023
Conditions
Outcome Measures
Primary Outcomes (6)
Phase 2, select optimal dose level of SCB-2019 vaccine by age cohort (5-11 years, 2-4 years, and < 2 years), based on safety
Proportion of subjects with solicited local and systemic adverse events
7 days after dose 1 (Day 1-7)
Phase 2, select optimal dose level of SCB-2019 vaccine by age cohort (5-11 years, 2-4 years, and < 2 years), based on safety
Proportion of subjects with solicited local and systemic adverse events
7 days after dose 2 (Day 22-28)
Phase 2, select optimal dose level of SCB-2019 vaccine in phase 2 by age cohort (5-11 years, 2-4 years, and < 2 years), based on immunogenicity
Geometric mean titer (GMT) of SARS-CoV-2 neutralising antibody (nAb)
Day 36
Phase 3, non-inferiority (GMT) of SARS-CoV-2 nAb titers of SCB-2019 vaccine when given to participants 5 to < 12 years as compared to young adults (18 to < 25 years)
GMT of SARS-CoV-2 nAb after 2 doses of SCB-2019 vaccine in participants 5 to 12 years over GMT in participants 18 to \< 25 years from CLO-SCB-2019-003 study
21/15 days after second SCB-2019 dose
Phase 3, non-inferiority (GMT) of SARS-CoV-2 nAb titers of SCB-2019 vaccine when given to participants 2 to < 5 years as compared to young adults (18 to < 25 years)
GMT of SARS-CoV-2 nAb after 2 doses of SCB-2019 vaccine in participants 2 to 5 years over GMT in participants 18 to \< 25 years from CLO-SCB-2019-003 study
21/15 days after second SCB-2019 dose
Phase 3, non-inferiority (GMT) of SARS-CoV-2 nAb titers of SCB-2019 vaccine when given to participants birth to < 2 years as compared to young adults (18 to < 25 years)
GMT of SARS-CoV-2 nAb after 2 doses of SCB-2019 vaccine in participants birth to 2 years over GMT in participants 18 to \< 25 years from CLO-SCB-2019-003 study
21/15 days after second SCB-2019 dose
Secondary Outcomes (14)
Phase 3, non-inferiority (SCR difference) of SARS-CoV-2 nAb titers of SCB-2019 vaccine when given to participants 5 to < 12 years as compared to young adults (18 to < 25 years)
21/15 days after second SCB-2019 dose
Phase 3, non-inferiority (SCR difference) of SARS-CoV-2 nAb titers of SCB-2019 vaccine when given to participants 2 to < 5 years as compared to young adults (18 to < 25 years)
21/15 days after second SCB-2019 dose
Phase 3, non-inferiority (SCR difference) of SARS-CoV-2 nAb titers of SCB-2019 vaccine when given to participants birth to < 2 years as compared to young adults (18 to < 25 years)
21/15 days after second SCB-2019 dose
In phase 2 and 3, GMT of SARS-CoV-2 nAb
Day 1 , 22 and 36 (phase 2) and Day 1, 43, 64, 226 and 410 (phase 3)
In phase 2 and 3, proportion of participants achieving seroconversion for SARS-CoV-2 nAb
Day 22 and 36 (phase 2) and Day 43, 64, 226 and 410 (phase 3)
- +9 more secondary outcomes
Study Arms (21)
SCB-2019/SCB-2019/placebo, 12 to < 18 yrs
EXPERIMENTALDay 1 and 22: SCB-2019, Day 43: placebo
Placebo/SCB-2019/SCB-2019, 12 to < 18 years
EXPERIMENTALDay 1: placebo, Day 22 and 43: SCB-2019
SCB-2019/placebo/SCB-2019, 12 to < 18 years
EXPERIMENTALDay 1 and 43: SCB-2019, Day 22: placebo
Low dose SCB-2019, 5 to < 12 years
EXPERIMENTALDay 1 and 22: SCB-2019
Mid dose SCB-2019, 5 to < 12 years
EXPERIMENTALDay 1 and 22: SCB-2019
High dose SCB-2019, 5 to < 12 years
EXPERIMENTALDay 1 and 22: SCB-2019
SCB-2019/SCB-2019/placebo, 5 to < 12 yrs
EXPERIMENTALDay 1 and 22: SCB-2019, Day 43: placebo
Placebo/SCB-2019/SCB-2019, 5 to < 12 years
EXPERIMENTALDay 1: placebo, Day 22 and 43: SCB-2019
SCB-2019/placebo/SCB-2019, 5 to < 12 years
EXPERIMENTALDay 1 and 43: SCB-2019, Day 22: placebo
Low dose SCB-2019, 2 to < 5 years
EXPERIMENTALDay 1 and 22: SCB-2019
Mid dose SCB-2019, 2 to < 5 years
EXPERIMENTALDay 1 and 22: SCB-2019
High dose SCB-2019, 2 to < 5 years
EXPERIMENTALDay 1 and 22: SCB-2019
SCB-2019/SCB-2019/placebo, 2 to < 5 yrs
EXPERIMENTALDay 1 and 22: SCB-2019, Day 43: placebo
Placebo/SCB-2019/SCB-2019, 2 to < 5 years
EXPERIMENTALDay 1: placebo, Day 22 and 43: SCB-2019
SCB-2019/placebo/SCB-2019, 2 to < 5 years
EXPERIMENTALDay 1 and 43: SCB-2019, Day 22: placebo
Low dose SCB-2019, birth to < 2 years
EXPERIMENTALDay 1 and 22: SCB-2019
Mid dose SCB-2019, birth to < 2 years
EXPERIMENTALDay 1 and 22: SCB-2019
High dose SCB-2019, birth to < 2 years
EXPERIMENTALDay 1 and 22: SCB-2019
SCB-2019/SCB-2019/placebo, birth to < 2 yrs
EXPERIMENTALDay 1 and 22: SCB-2019, Day 43: placebo
Placebo/SCB-2019/SCB-2019, birth to < 2 years
EXPERIMENTALDay 1: placebo, Day 22 and 43: SCB-2019
SCB-2019/placebo/SCB-2019, birth to < 2 years
EXPERIMENTALDay 1 and 43: SCB-2019, Day 22: placebo
Interventions
a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19
Eligibility Criteria
You may qualify if:
- Individuals and their legally authorized representative (LAR) are willing and able to comply with study requirements, including all scheduled visits, vaccinations, laboratory tests and other study procedures.
- Individuals are willing and able to give an assent (if applicable) and their LARs are willing and able to give informed consent on their behalf, prior to screening
- Healthy participants (phase 2 and phase 3) or participants with pre-existing medical conditions who are in a stable medical condition (phase 2)
- For infants (\<1-year-old) - born at full term (gestational age ≥37 weeks) and with a normal birth weight (≥2500 grams).
- Female participants of childbearing potential may be enrolled in the study, if the participant has practiced highly effective contraception for 30 days prior to vaccination, and has a negative pregnancy test on the day of vaccination and has agreed to continue adequate contraception for 3 months after the last vaccination
You may not qualify if:
- Individuals with fever \>38.0°C \[≥ 100.4°F\] (irrespective of method used), or any acute illness at baseline (Day 1) or within 3 days prior to randomization.
- Individuals with laboratory-confirmed SARS-CoV-2 infection \[as defined by Rapid COVID Antigen Test or an equivalent at Day 1\] or with history of laboratory-confirmed/medically-diagnosed COVID-19 (for phase 2 participants only).
- Individuals who have received an investigational or licensed COVID-19 vaccine prior to Day 1, or plan to receive an investigational or licensed COVID-19 vaccine during the study period.
- Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease \[e.g., malignancy, human immunodeficiency virus (HIV) infection\] or immunosuppressive/cytotoxic therapy (e.g., systemic corticosteroids, medications used for cancer chemotherapy, organ transplantation or to treat autoimmune disorders) within 3 months prior to Day 1. Inhaled, intranasal, topical steroids as well as a single dose of systemic steroids, are allowed.
- Individuals with any progressive or severe neurologic disorder, seizure disorder (including febrile seizures) or history of Guillain-Barré syndrome.
- Individuals who are pregnant, or breastfeeding, or planning to become pregnant while enrolled in this study or during the study period.
- Individuals who have a history of severe adverse reaction associated with a vaccine or severe allergic reaction
- Individuals who have received any other investigational product within 30 days prior to Day 1 or intend to participate in another clinical study at any time during the conduct of this study.
- Individuals who have received any other licensed vaccines within 14 days prior to enrollment in this study or who are planning to receive any vaccine up to 28 days after the second (phase 2) or third (phase 3) vaccination.
- Individuals with known bleeding disorder that would, in the opinion of the investigator, contraindicate intramuscular injection
- Administration of intravenous immunoglobulins and/or any blood products within 3 months prior to enrollment or planned administration during the study period
- Individuals with any condition that, in the opinion of the investigator, would interfere with the primary study objectives or pose additional risk to the participant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Clínica de la Costa Ltda
Barranquilla, 080020, Colombia
Centro de Estudios en Infectología Pediátrica S.A.S. - CEIP S.A.S.
Cali, Colombia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 23, 2021
First Posted
January 14, 2022
Study Start
October 5, 2022
Primary Completion
December 15, 2022
Study Completion
December 15, 2022
Last Updated
March 24, 2023
Record last verified: 2023-03