The study evaluated the safety, tolerability, reactogenicity, and effectiveness of mRNA-1273.214 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine in infants aged 12 weeks to \< 6 months.
The purpose of this pediatric study was to confirm safety and effectiveness of mRNA-1273.214 in infants between 12 weeks to \< 6 months of age by comparing the immune response of infants in this study to adults (\>18 years of age) enrolled in the mRNA-1273-P301 study \[NCT04470427\]). The study was planned to be conducted in 2 parts. Part 1 was open-label and evaluated 2 dose levels. The dose level selected from Part 1 was planned to be further evaluated in Part 2. However, data from the dose finding part of the trial (Part 1) did not support further evaluation of effectiveness of mRNA-1273 and accordingly, Part 2 of the study was not conducted and the trial was terminated. There were no safety concerns.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
68
Sterile liquid for injection
0.9% sodium chloride
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) After First Injection
Solicited ARs (local and systemic) were collected in an electronic diary (eDiary). Local ARs included injection site pain/tenderness, injection site erythema (redness), injection site swelling/induration (hardness), and groin or underarm swelling or tenderness ipsilateral to the side of injection. Systemic ARs included fever, irritability/crying, sleepiness, and loss of appetite. Solicited AR severity was graded according to a modified version (relevant to age 12 weeks to \<6 months) of the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials. ARs graded 1-4 are presented. Lower scores indicated lower severity, and higher scores indicated greater severity. A summary of serious adverse events (SAEs) and nonserious adverse events (AEs) (Safety Set), regardless of causality, is located in the AE section.
Time frame: Day 1 up to 7 days after first vaccination (up to Day 8)
Number of Participants With Solicited Local and Systemic ARs After Second Injection
Solicited ARs (local and systemic) were collected in eDiary. Local ARs included injection site pain/tenderness, injection site erythema (redness), injection site swelling/induration (hardness), and groin or underarm swelling or tenderness ipsilateral to the side of injection. Systemic ARs included fever, irritability/crying, sleepiness, and loss of appetite. Solicited AR severity was graded according to a modified version (relevant to age 12 weeks to \<6 months) of the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials. ARs graded 1-4 are presented. Lower scores indicated lower severity, and higher scores indicated greater severity. A summary of SAEs and nonserious AEs (Safety Set), regardless of causality, is located in the AE section.
Time frame: Day 57 up to 7 days after second vaccination (up to Day 64)
Number of Participants With Unsolicited Adverse Events (AEs) After Any Injection
An unsolicited AE was any AE reported by the participant that was not specified as a solicited AR in the protocol or was specified as a solicited AR but started outside the protocol-defined period for reporting solicited ARs (onset after Day 7 of dosing). An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result or other safety assessment, including one that worsened from baseline and was considered clinically significant by the Investigator was recorded as an AE. A summary of SAEs and nonserious AEs (Safety Set), regardless of causality, is located in the AE section. COVID-19/SARS-CoV-2 infections were considered clinical events and not AEs.
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Trinity Clinical Research, LLC - Bessemer
Bessemer, Alabama, United States
UAB Pediatrics
Birmingham, Alabama, United States
Eclipse Clinical Research
Tucson, Arizona, United States
Madera Family Medical Group
Madera, California, United States
SeraCollection Research Services LLC
Montebello, California, United States
Center For Clinical Trials LLC
Paramount, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Meridian Clinical Research (Washington) - PPDS
Washington D.C., District of Columbia, United States
PAS Research
Clearwater, Florida, United States
Prohealth Research Center
Doral, Florida, United States
...and 29 more locations
Time frame: Day 1 up to 28 days after any vaccination (up to Day 85)
Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Study or Treatment Discontinuation
SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. AESIs were identified based upon medical concepts that may be related to COVID-19 or were of interest in COVID-19 vaccine safety surveillance. MAAE was an AE that led to an unscheduled visit to a healthcare practitioner, included visits to a study site for unscheduled assessments (for example, abnormal laboratory follow-up, and visits to healthcare practitioners external to the study site \[for example, urgent care, primary care physician\]). A summary of SAEs and nonserious AEs (Safety Set), regardless of causality, is located in the AE section. COVID-19/SARS-CoV-2 infections were considered clinical events and not AEs.
Time frame: Day 1 up to Day 422
Geometric Mean Concentration (GMC) of Serum Pseudovirus Neutralizing Antibod (nAb) Titers Against SARS-CoV-2 Omicron BA.1 Variant (B.1.1.529) After Second Dose of mRNA-1273.214
Pseudovirus nAb were measured using pseudovirus neutralization assay (PsVNA). Antibody values reported as below the lower limit of quantification (LLOQ) were replaced by 0.5\*LLOQ. Values greater than the upper limit of quantification (ULOQ) were replaced by the ULOQ if actual values were not available. VAC122 nAb against the SARS-CoV-2 B.1.1.529 variant (LLOQ: 8 arbitrary unit (AU)/milliliter (mL), ULOQ: 24503 AU/mL).
Time frame: Baseline and 28 days after second dose (Day 85)
GMC of Serum Pseudovirus nAb Titers Against SARS-CoV-2 Original Strain (D614G) After Second Dose of mRNA-1273.214
Pseudovirus nAb were measured using PsVNA assay. Antibody values reported as below the LLOQ were replaced by 0.5\*LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available. VAC62 Neutralizing Antibody against D614G (LLOQ: 10 AU/mL, ULOQ: 111433 AU/mL).
Time frame: Baseline and 28 days after second dose (Day 85)