Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
V110 · 1 trial · 1 indication
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs include redness, swelling, pain/tenderness, and underarm gland swelling or tenderness/lymphadenopathy at the injection site. The percentage of participants with one or more solicited injection-site AEs following any vaccination was reported.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs include redness, swelling, pain/tenderness, and underarm gland swelling or tenderness/lymphadenopathy at the injection site. The percentage of participants with one or more solicited injection-site AEs following any vaccination was reported.
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Systemic adverse events (AEs) include headache, tiredness/fatigue, muscle aches all over body/myalgia, joint pain/arthralgia, nausea, vomiting, and chills. The percentage of participants with solicited systemic AEs following any vaccination was reported.
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Systemic adverse events (AEs) include headache, tiredness/fatigue, muscle aches all over body/myalgia, joint pain/arthralgia, nausea, vomiting, and chills. The percentage of participants with solicited systemic AEs following any vaccination was reported.
Serious adverse events (SAEs) are defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of a participant, or other important medical events. V110 vaccine-related SAEs as determined by investigator are summarized.
SAEs are defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of a participant, or other important medical events. V114 vaccine-related SAEs as determined by investigator are summarized.
Serotype-specific OPA GMTs for 14 of the serotypes contained in V110 were determined using a multiplexed opsonophagocytic assay (MOPA) at 30 days postvaccination with V110. The within-group 95% confidence intervals (CIs) were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Serotype-specific OPA GMTs for 15 of the serotypes contained in V114 were determined using a MOPA at 30 days postvaccination with V114. The within-group 95% CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Sera from participants were used to measure vaccine-induced bAb responses using a validated ligand-binding assay specific to the SARS-CoV-2 Spike protein at 30 days post vaccination. The within-group 95% CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. As prespecified by the protocol and statistical analysis plan, the V110 nonconcomitant group and V114 nonconcomitant group were combined for this analysis, as they shared the same administration for the first visit (mRNA-1273 and placebo).
| Arm | Type | Description |
|---|---|---|
| V110 Concomitant with mRNA-1273 (V110 Concomitant) | EXPERIMENTAL | Participants received a single 0.5 mL intramuscular (IM) injection of V110 concomitantly with a single 0.25 mL IM injection of mRNA-1273 on Day 1, followed by a single 0.5 mL IM injection of placebo for V110 on Day 30. |
| V110 Nonconcomitant with mRNA-1273 (V110 Nonconcomitant) | EXPERIMENTAL | Participants received a single 0.5 mL IM injection of placebo for V110 on Day 1 concomitantly with a single 0.25 mL IM injection of mRNA-1273, followed by a single 0.5 mL IM injection of V110 on Day 30. |
| V114 Concomitant with mRNA-1273 (V114 Concomitant) | EXPERIMENTAL | Participants received a single 0.5 mL IM injection of V114 concomitantly with a single 0.25 mL IM injection of mRNA-1273 on Day 1, followed by a single 0.5 mL IM injection of placebo for V114 on Day 30. |
| V114 Nonconcomitant with mRNA-1273 (V114 Nonconcomitant) | EXPERIMENTAL | Participants received single 0.5 mL IM injection of placebo for V114 on Day 1 concomitantly with a single 0.25 mL IM injection of mRNA-1273, followed by a single 0.5 mL IM injection of V114 on Day 30. |
| Name | Type | Description |
|---|---|---|
| V110 | BIOLOGICAL | Single intramuscular (IM) dose of 0.5 mL V110, a pneumococcal polysaccharide vaccine (PCV), containing the 23 serotypes: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F |
| V114 | BIOLOGICAL | Single IM dose of 0.5 mL V114 a 15-valent PCV containing the 15 serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F |
| mRNA-1273 | BIOLOGICAL | Single IM dose of 50 μg/0.25 mL mRNA-1273 |
| Placebo for V110 | BIOLOGICAL | Single IM dose of 0.5 mL placebo for V110 |
| Placebo for V114 | BIOLOGICAL | Single IM dose of 0.5 mL placebo for V114 |
Inclusion Criteria: * Is in good health * Any underlying chronic illness must be documented to be in stable condition * Has received a 2-dose primary series of the Moderna mRNA SARS-CoV-2 vaccine ≥5 months before receipt of study vaccine at Visit 1 * May have received either: a) A first booster dos...
V110 is an investigational pneumococcal vaccine being studied for the prevention of pneumococcal infection in healthy adults. It is a monoclonal antibody modality developed by Merck & Company, Inc. (MRK). The vaccine is intended to protect against diseases caused by Streptococcus pneumoniae bacteria.
V110 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. Merck is conducting clinical trials to evaluate the safety and immunogenicity of V110 in healthy adult populations.
V110 is currently in Phase 3 clinical development. Two Phase 3 trials have been completed, including a study of V110 in healthy adults and a study of V110 co-administered with a booster dose of the mRNA-1273 COVID-19 vaccine. V110 remains investigational and is not yet approved.
V110 has been evaluated in two completed Phase 3 clinical trials. NCT00127153 studied V110 as a pneumococcal vaccine in 130 healthy adults. NCT05158140 evaluated the safety, tolerability, and immunogenicity of V110 co-administered with a booster dose of mRNA-1273 in 850 healthy adults aged 50 years and older.
V110 and V114 are distinct investigational pneumococcal vaccines, though they are both being developed by Merck. In clinical trial NCT05158140, V110 was studied alongside V114, with both vaccines co-administered with a booster dose of mRNA-1273 in healthy adults. They are separate vaccine candidates.