Spikevax Bivalent Original/Omicron BA.1 (mRNA-1273.214) / Moderna - LARVOL DELTA

A Study to Evaluate the Safety and Immunogenicity of the mRNA COVID-19 Vaccines in Healthy Children Between 6 Months to Less Than 6 Years of Age (clinicaltrials.gov) - P3 | N=1807 | Completed | Sponsor: ModernaTX, Inc. | Recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Development and characterization of a bivalent mRNA vaccine targeting the Delta and Omicron variants of SARS-CoV-2. (PubMed, Hum Vaccin Immunother) - "These findings suggest that ARCoV-Biv may serve as a foundational platform for future vaccine optimization against newly emerging SARS-CoV-2 strains. Compared to mRNA-1273.214 (Moderna), a bivalent vaccine, ARCoV-Biv demonstrated a higher neutralization breadth against Delta and Omicron BA.1, along with enhanced T-cell responses, indicating potential advantages in cross-variant protection and durability."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Membranous Nephropathy after mRNA 1273 (NKF-SCM 2025) - "mRNA 1273.214 was given one month prior.Results Creatinine is 1.01 to 1.40 mg/dl...Light microscopic, immunofluorescence staining for IgG, and electron microscopy specimens are shown below:Conclusion The patient was maintained on telmisartan, nebivolol, dapagliflozin, metformin, glipizide, evolocumab, and atorvastatin...Boosting with five doses of the vaccine and exposure to the Covid-19 virus may all have exacerbated this autoimmune response. The diminution of proteinuria from 2888 milligrams to 2112 milligrams 21 days later to 203 mg nineteen months after the final vaccine administration suggest that the antigen antibody complexes deposited in the glomerular basement membrane cleared and that the biopsy documented membranous nephropathy at the time of the acute proteinuria has resolved."

Glomerulonephritis • Hematological Disorders • Hepatitis B • Hepatitis C • Hepatology • Immunology • Infectious Disease • Novel Coronavirus Disease • Oncology • Renal Disease • C1QB • NELL1

The immunogenicity, reactogenicity, and safety of a bivalent mRNA or protein COVID-19 vaccine given as a fourth dose. (PubMed, J Infect) - P3 | "At day 28 post-vaccination, higher immunogenicity was observed following Moderna vaccination compared to Novavax vaccination when given as a fourth dose in healthy adults for Ancestral and Omicron subvariants, including JN.1. However, local and systemic reactogenicity was higher in the Moderna vaccine group compared with the Novavax vaccine group. These results may have important implications for ongoing booster strategies."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

BabyCOVE: Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273.214 SARS-CoV-2 (COVID-19) Vaccine in Infants (clinicaltrials.gov) - P2 | N=68 | Terminated | Sponsor: ModernaTX, Inc. | N=700 ➔ 68 | Trial completion date: Mar 2025 ➔ Nov 2024 | Active, not recruiting ➔ Terminated | Trial primary completion date: Mar 2025 ➔ Nov 2024; The trial was terminated because data from the dose finding part of the trial did not support further evaluation of effectiveness of mRNA-1273. There were no safety concerns.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

RSVictory: A Study of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥50 Years of Age (clinicaltrials.gov) - P3 | N=3800 | Completed | Sponsor: ModernaTX, Inc. | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Safety and immunogenicity of mRNA-1345 RSV vaccine coadministered with an influenza or COVID-19 vaccine in adults aged 50 years or older: an observer-blinded, placebo-controlled, randomised, phase 3 trial. (PubMed, Lancet Infect Dis) - P3 | "Coadministered mRNA-1345 plus SIIV4 or mRNA-1273.214 vaccines had acceptable safety profiles and elicited mostly non-inferior immune responses compared to individual vaccines in adults aged 50 years or older; only the seroresponse rate difference in nAbs against RSV-A in part A did not meet the non-inferiority criterion. Overall, these data support coadministration of mRNA-1345 with these vaccines in this population; longer-term evaluation continues in this study."

Journal • P3 data • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Ipsilateral or contralateral boosting of mice with mRNA vaccines confers equivalent immunity and protection against a SARS-CoV-2 Omicron strain. (PubMed, J Virol) - "Here, we boosted K18-hACE2 mice with either monovalent mRNA-1273 (Wuhan-1 spike) or bivalent mRNA-1273.214 (Wuhan-1 + BA.1 spike) vaccine in the ipsilateral or contralateral leg after a two-dose priming series with mRNA-1273. Moreover, boosting on either side conferred equivalent protection against a SARS-CoV-2 Omicron challenge strain. Our data in mice suggest that the site of intramuscular boosting with an mRNA vaccine does not substantially impact immunity or protection against SARS-CoV-2 infection."

Journal • Preclinical • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD8

BabyCOVE: Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273.214 SARS-CoV-2 (COVID-19) Vaccine in Infants (clinicaltrials.gov) - P2 | N=700 | Active, not recruiting | Sponsor: ModernaTX, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Antibody and T-cell response to bivalent booster SARS-CoV-2 vaccines in people with compromised immune function (COVERALL-3). (PubMed, J Infect Dis) - "Bivalent mRNA vaccination elicited a robust humoral response in individuals with HIV or solid organ transplants, with delayed responses in lung transplant recipients. Despite a waning effect, antibody levels remained high at 6 months and adverse events were rare."

Journal • Human Immunodeficiency Virus • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • Solid Organ Transplantation • Transplantation

Immunogenicity of a bivalent BA.1 COVID-19 booster vaccine in people with HIV in the Netherlands. (PubMed, AIDS) - "A bivalent BA.1 booster vaccine was immunogenic in well-treated PWH, eliciting comparable humoral responses to non-PWH. However, T-cell responses waned faster after 90 days in PWH compared to non-PWH."

Journal • Human Immunodeficiency Virus • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4 • IFNG • IL2 • IL4

A Study to Evaluate the Safety and Immunogenicity of the mRNA-1273 COVID-19 Vaccines in Healthy Children Between 6 Months to Less Than 6 Years of Age (clinicaltrialsregister.eu) - P3 | N=1860 | Sponsor: ModernaTX, Inc.

New P3 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

SAFETY AND IMMUNOGENICITY OF A COVID-19 OMICRON BA.1 VARIANT-TARGETING PRIMARY SERIES VACCINE IN CHILDREN: RESULTS FROM AN OPEN-LABEL, PHASE 3 TRIAL (ESPID 2024) - P2/3, P3 | "nAb titers against BA.1 and D614G after the mRNA-1273.214 PS persisted through D209 (N=133). Conclusions/Learning Points In children aged 6 months-5 years, the mRNA-1273.214 PS was well-tolerated and effective based on successful immunobridging, with immune responses persisting through 6 months post-dose-2."

Clinical • P3 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Six-Month Safety and Immunogenicity of mRNA-1273.214 Booster Vaccination in Individuals Aged 6 Months to <6 Years: Interim Results From a Phase 3, Open-Label Trial (PAS 2024) - P3 | "There were 539 mRNA-1273.214 booster recipients included in this interim analysis; median age was 3 years, and most participants were male (Table). At 6 months post-booster, mRNA-1273.214 had a similar safety profile as the mRNA-1273 primary series and was generally well-tolerated. Incidence of serious adverse events (SAEs) was low (1.7%) and none were vaccine-related; 4 adverse events of special interest were reported, of which 1 (erythema multiforme on BD-D2) was considered related."

Clinical • P3 data • P3 data: top line • Dermatology • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273.214 SARS-CoV-2 (COVID-19) Vaccine in Infants (clinicaltrialsregister.eu) - P2 | N=700 | Sponsor: ModernaTX, Inc.

New P2 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

RSVictory: A Study of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥50 Years of Age (clinicaltrials.gov) - P3 | N=3800 | Active, not recruiting | Sponsor: ModernaTX, Inc. | Trial primary completion date: Mar 2024 ➔ Nov 2024

Trial primary completion date • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Study to Evaluate the Safety and Immunogenicity of the mRNA COVID-19 Vaccines in Healthy Children Between 6 Months to Less Than 6 Years of Age (clinicaltrials.gov) - P3 | N=1860 | Recruiting | Sponsor: ModernaTX, Inc. | Active, not recruiting ➔ Recruiting | N=931 ➔ 1860 | Trial completion date: Jun 2024 ➔ Oct 2025 | Trial primary completion date: Jun 2024 ➔ Oct 2025

Enrollment change • Enrollment open • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Study to Evaluate Safety and Effectiveness of mRNA-1273 COVID-19 Vaccine in Healthy Children Between 6 Months of Age and Less Than 12 Years of Age (clinicaltrials.gov) - P2/3 | N=11950 | Completed | Sponsor: ModernaTX, Inc. | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Interim safety and immunogenicity of COVID-19 omicron BA.1 variant-containing vaccine in children in the USA: an open-label non-randomised phase 3 trial. (PubMed, Lancet Infect Dis) - P2/3, P3 | "mRNA-1273.214 was immunogenic against BA.1 and D614G in children aged 6 months to 5 years, with a comparable safety profile to mRNA-1273, when given as a two-dose primary series or a booster dose. These results are aligned with the US Centers for Disease Control and Prevention recommendations for the use of variant-containing vaccines for continued protection against the emerging variants of SARS-CoV-2."

Journal • P3 data • P3 data: top line • Infectious Disease • Novel Coronavirus Disease • Pediatrics • Respiratory Diseases

BabyCOVE: Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273.214 SARS-CoV-2 (COVID-19) Vaccine in Infants (clinicaltrials.gov) - P2 | N=700 | Recruiting | Sponsor: ModernaTX, Inc. | Trial primary completion date: Mar 2024 ➔ Mar 2025

Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Safety, Reactogenicity, and Immunogenicity Study of mRNA-1045 (Influenza and Respiratory Syncytial Virus [RSV]) or mRNA-1230 (Influenza, RSV, and Severe Acute Respiratory Syndrome Coronavirus 2 [SARS-CoV-2]) Vaccine in Adults 50 to 75 Years Old (clinicaltrials.gov) - P1 | N=392 | Completed | Sponsor: ModernaTX, Inc. | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

SH-MO-214: Safety and Immunogenicity of Omicron Variant-Matched Vaccine Booster in Adults (clinicaltrials.gov) - P2 | N=179 | Completed | Sponsor: Sheba Medical Center | Recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG

I-SPARC: COVID-19: Immune Response in Patients With Cancer Undergoing mRNA Vaccination Against SARS-CoV-2 (clinicaltrials.gov) - P4 | N=152 | Terminated | Sponsor: Jules Bordet Institute | N=440 ➔ 152 | Trial completion date: Dec 2024 ➔ Jan 2024 | Recruiting ➔ Terminated; The population as defined by the inclusion/exclusion criteria and the study logistics were leading to a poor recruitment over the past years.

Enrollment change • Trial completion date • Trial termination • Infectious Disease • Novel Coronavirus Disease • Oncology • Respiratory Diseases

A Study to Evaluate the Immunogenicity and Safety of Omicron Variant Vaccines in Comparison With mRNA-1273 Booster Vaccine for COVID-19 (clinicaltrialsregister.eu) - P2/3 | N=3924 | Sponsor: ModernaTX, Inc.

New P2/3 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

I-SPARC: COVID-19: Immune Response in Patients With Cancer Undergoing mRNA Vaccination Against SARS-CoV-2 (clinicaltrials.gov) - P4 | N=440 | Recruiting | Sponsor: Jules Bordet Institute

Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Oncology • Respiratory Diseases