| Primary | Seroconversion Rate (SCR) on Day 56 | Seroconversion Rate (SCR), defined as percentage of subjects achieving a ≥4-fold increase in antibody titer from Day 0, for IgG against both Toxin A and Toxin B on Day 56; | per-protocol population,i.e., subjects who received at least one study vaccination without any major protocol deviation up to Day 210 | Posted | | Number | 95% Confidence Interval | percentage of study participants | | Day 56 | | | | ID | Title | Description |
|---|
| OG000 | VLA84 75 mcg (Microgram) w/o Alum | VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B Placebo: phosphate buffered saline (PBS) solution | | OG001 | VLA84 200 mcg w/o Alum | VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B | | OG002 | VLA84 200 mcg With Alum | VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B | | OG003 | Placebo | Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections Placebo: phosphate buffered saline (PBS) solution |
| | Units | Counts |
|---|
| Participants | - OG000137
- OG001135
- OG002141
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00071.5(63.5 to 78.4)
- OG00183.0(75.7 to 88.4)
- OG00259.6(51.3 to 67.3)
- OG003
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Cochran-Mantel-Haenszel | | <0.0001 | | | | | | | | | | | | | | Superiority or Other | | | | | Cochran-Mantel-Haenszel | | 0.0261 | |
|
| Secondary | SCR for IgG (Immunoglobulin G) Against Both Toxin A and Toxin B | Seroconversion Rate (SCR), defined as percentage of subjects achieving a ≥4-fold increase in antibody titer from Day 0, for IgG against both Toxin A and Toxin B on Day 14, 28, 35, 120 and 210; | per-protocol population,i.e., subjects who received at least one study vaccination without any major protocol deviation up to Day 210 | Posted | | Number | 95% Confidence Interval | percentage of participants | | Days 14, 28, 35, 120 and 210 | | | | ID | Title | Description |
|---|
| OG000 | VLA84 75 mcg (Microgram) w/o Alum | VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B Placebo: phosphate buffered saline (PBS) solution | | OG001 | VLA84 200 mcg w/o Alum | VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B | | OG002 | VLA84 200 mcg With Alum | |
|
| Secondary | Seroconversion Rate (SCR) for IgG Against Toxin A | Seroconversion Rate (SCR), defined as percentage of subjects achieving a ≥4-fold increase in antibody titer from Day 0, for IgG against Toxin A; | per-protocol population,i.e., subjects who received at least one study vaccination without any major protocol deviation up to Day 210 | Posted | | Number | 95% Confidence Interval | percentage of participants | | 14, 28, 35, 56, 120 and 210 | | | | ID | Title | Description |
|---|
| OG000 | VLA84 75 mcg (Microgram) w/o Alum | VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B Placebo: phosphate buffered saline (PBS) solution | | OG001 | VLA84 200 mcg w/o Alum | VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B | | OG002 | VLA84 200 mcg With Alum | VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B |
|
| Secondary | Seroconversion Rate (SCR) for IgG Against Toxin B | Seroconversion Rate (SCR), defined as percentage of subjects achieving a ≥4-fold increase in antibody titer from Day 0, for IgG against Toxin B; | per-protocol population,i.e., subjects who received at least one study vaccination without any major protocol deviation up to Day 210 | Posted | | Number | 95% Confidence Interval | percentage of participants | | Days 14, 28, 35, 56, 120 and 210 | | | | ID | Title | Description |
|---|
| OG000 | VLA84 75 mcg (Microgram) w/o Alum | VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B Placebo: phosphate buffered saline (PBS) solution | | OG001 | VLA84 200 mcg w/o Alum | VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B | | OG002 | VLA84 200 mcg With Alum | VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B |
|
| Secondary | Geometric Mean Titer (GMT) for IgG Against Toxin A | Geometric Mean Titer (GMT) for IgG against Toxin A as determined by ELISA on Days 0, 14, 28, 35, 56 (primary endpoint time point), 120 and 210; | PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210 | Posted | | Geometric Mean | 95% Confidence Interval | EU/ml | | Days 0, 14, 28, 35, 56, 120 and 210 | | | | ID | Title | Description |
|---|
| OG000 | VLA84 75 mcg (Microgram) w/o Alum | VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B Placebo: phosphate buffered saline (PBS) solution | | OG001 | VLA84 200 mcg w/o Alum | VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B | | OG002 | VLA84 200 mcg With Alum | VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B |
|
| Secondary | Geometric Mean Titer (GMT) for IgG Against Toxin B | Geometric Mean Titer (GMT) for IgG against Toxin B as determined by ELISA on Days 0, 14, 28, 35, 56 (primary endpoint time point), 120 and 210; | PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210 | Posted | | Geometric Mean | 95% Confidence Interval | EU/ml | | Days 0, 14, 28, 35, 56, 120 and 210 | | | | ID | Title | Description |
|---|
| OG000 | VLA84 75 mcg (Microgram) w/o Alum | VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B Placebo: phosphate buffered saline (PBS) solution | | OG001 | VLA84 200 mcg w/o Alum | VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B | | OG002 | VLA84 200 mcg With Alum | VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B |
|
| Secondary | GMT for Toxin A Neutralizing Antibodies | GMT for Toxin A neutralizing antibodies (TNA) as determined by Toxin Neutralization Assay on Days 0, 35, 56, 120* and 210 * TNA in sera from Day 120 were to be measured only if meaningful in view of the Day 56 and Day 210 results; in fact Day 120 TNA was not measured. | PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210 | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | Days 0, 35, 56, 120 and 210 | | | | ID | Title | Description |
|---|
| OG000 | VLA84 75 mcg (Microgram) w/o Alum | VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B Placebo: phosphate buffered saline (PBS) solution | | OG001 | VLA84 200 mcg w/o Alum | VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B | | OG002 | VLA84 200 mcg With Alum | |
|
| Secondary | GMT for Toxin B Neutralizing Antibodies | GMT for Toxin B neutralizing antibodies (TNA) as determined by Toxin Neutralization Assay on Days 0, 35, 56, 120* and 210 * TNA in sera from Day 120 were to be measured only if meaningful in view of the Day 56 and Day 210 results; in fact Day 120 TNA was not measured. | PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210 | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | Days 0, 35, 56, 120 and 210 | | | | ID | Title | Description |
|---|
| OG000 | VLA84 75 mcg (Microgram) w/o Alum | VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B Placebo: phosphate buffered saline (PBS) solution | | OG001 | VLA84 200 mcg w/o Alum | VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B | | OG002 | VLA84 200 mcg With Alum | |
|
| Secondary | SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group | Seroconversion Rate (SCR) for IgG against Toxin A, against Toxin B and against both Toxin A and Toxin B on Days 14, 28, 35, 56, 120 and 210, stratified by age group (subjects 50 - < 65 years and 65 years and older) | PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210 | Posted | | Number | 95% Confidence Interval | percentage of participants | | Days 14, 28, 35, 56, 120 and 210 | | | | ID | Title | Description |
|---|
| OG000 | VLA84 75 mcg (Microgram) w/o Alum | VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B Placebo: phosphate buffered saline (PBS) solution | | OG001 | VLA84 200 mcg w/o Alum | VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B | | OG002 | VLA84 200 mcg With Alum | |
|
| Secondary | GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group | GMT for IgG against Toxin A and against Toxin B on Days 0, 14, 28, 35, 56, 120 and 210, stratified by age group (subjects 50 - < 65 years and 65 years and older) | PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210 | Posted | | Geometric Mean | 95% Confidence Interval | EU/ml | | Days 0, 14, 28, 35, 56, 120, 210 | | | | ID | Title | Description |
|---|
| OG000 | VLA84 75 mcg (Microgram) w/o Alum | VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B Placebo: phosphate buffered saline (PBS) solution | | OG001 | VLA84 200 mcg w/o Alum | VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B | | OG002 | VLA84 200 mcg With Alum | VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B |
|
| Secondary | GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group | GMTs for Toxin A neutralizing antibodies and for Toxin B neutralizing antibodies as determined by Toxin Neutralization Assay on Days 0, 35, 56, 120* and 210, stratified by age group (subjects 50 - < 65 years and 65 years and older) * TNA in sera from Day 120 were to be measured only if meaningful in view of the Day 56 and Day 210 results; in fact Day 120 TNA was not measured. | PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210 | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | Days 0, 35, 56, 120 and 210 | | | | ID | Title | Description |
|---|
| OG000 | VLA84 75 mcg (Microgram) w/o Alum | VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B Placebo: phosphate buffered saline (PBS) solution | | OG001 | VLA84 200 mcg w/o Alum | VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B | | OG002 |
|
| Secondary | Responder Rate (RR) for Neutralizing Antibodies Against Both Toxin A and Toxin B | Responder Rate (RR) (defined as percentage of subjects achieving a ≥4-fold increase in neutralizing antibody titer from Day 0) for neutralizing antibodies against both Toxin A and Toxin B on Days 35, 56, 120* and 210 * TNA in sera from Day 120 were to be measured only if meaningful in view of the Day 56 and Day 210 results; in fact Day 120 TNA was not measured. | PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210 | Posted | | Number | 95% Confidence Interval | percentage of participants | | Days 35, 56, 120, 210 | | | | ID | Title | Description |
|---|
| OG000 | VLA84 75 mcg (Microgram) w/o Alum | VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B Placebo: phosphate buffered saline (PBS) solution | | OG001 | VLA84 200 mcg w/o Alum | VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B | | OG002 |
|
| Secondary | Responder Rate (RR) for Toxin A Neutralizing Antibodies | Responder Rate (RR) (defined as percentage of subjects achieving a ≥4-fold increase in neutralizing antibody titer from Day 0) for neutralizing antibodies against Toxin A on Days 35, 56, 120* and 210 * TNA in sera from Day 120 were to be measured only if meaningful in view of the Day 56 and Day 210 results; in fact Day 120 TNA was not measured. | PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210 | Posted | | Number | 95% Confidence Interval | percentage of participants | | Days 35, 56, 120 and 210 | | | | ID | Title | Description |
|---|
| OG000 | VLA84 75 mcg (Microgram) w/o Alum | VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B Placebo: phosphate buffered saline (PBS) solution | | OG001 | VLA84 200 mcg w/o Alum | VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B | | OG002 | VLA84 200 mcg With Alum |
|
| Secondary | Responder Rate (RR) for Toxin B Neutralizing Antibodies | Responder Rate (RR) (defined as percentage of subjects achieving a ≥4-fold increase in neutralizing antibody titer from Day 0) for neutralizing antibodies against Toxin B on Days 35, 56, 120* and 210 * TNA in sera from Day 120 were to be measured only if meaningful in view of the Day 56 and Day 210 results; in fact Day 120 TNA was not measured. | PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210 | Posted | | Number | 95% Confidence Interval | percentage of participants | | Days 35, 56, 120 and 210 | | | | ID | Title | Description |
|---|
| OG000 | VLA84 75 mcg (Microgram) w/o Alum | VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B Placebo: phosphate buffered saline (PBS) solution | | OG001 | VLA84 200 mcg w/o Alum | VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B | | OG002 | VLA84 200 mcg With Alum |
|
| Secondary | Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group | Responder Rate for neutralizing antibodies against Toxin A (RR Tox A), against Toxin B (RR Tox B) and against both Toxin A and Toxin B (RR Tox A and B) on Days 35, 56, 120* and 210, stratified by age group (subjects 50 - < 65 years and 65 years and older) * TNA in sera from Day 120 were to be measured only if meaningful in view of the Day 56 and Day 210 results; in fact Day 120 TNA was not measured. | PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210 | Posted | | Number | 95% Confidence Interval | percentage of participants | | Days 35, 56, 120 and 210 | | | | ID | Title | Description |
|---|
| OG000 | VLA84 75 mcg (Microgram) w/o Alum | VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B Placebo: phosphate buffered saline (PBS) solution | | OG001 | VLA84 200 mcg w/o Alum | VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B |
|
| Secondary | Rate of Study Participants With at Least One SAE (Serious Adverse Event) | percentage of study participants with at least one SAE starting up to Day 56 and up to Day 210 | Safety Population = study participants who received at least one study vaccination | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 56 and Day 210 | | | | ID | Title | Description |
|---|
| OG000 | VLA84 75 mcg (Microgram) w/o Alum | VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B Placebo: phosphate buffered saline (PBS) solution | | OG001 | VLA84 200 mcg w/o Alum | VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B | | OG002 | VLA84 200 mcg With Alum | VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B |
|
| Secondary | Rate of Study Participants With at Least One Related SAE | percentage of study participants with at least one related SAE starting up to Day 56 and up to Day 210 | Safety Population = study participants with at least one study vaccination | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 56 and Day 210 | | | | ID | Title | Description |
|---|
| OG000 | VLA84 75 mcg (Microgram) w/o Alum | VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B Placebo: phosphate buffered saline (PBS) solution | | OG001 | VLA84 200 mcg w/o Alum | VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B | | OG002 | VLA84 200 mcg With Alum | VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B |
|
| Secondary | Rate of Study Participants With at Least One Unsolicited AEs (Adverse Event) | percentage of study participants with at least one unsolicited AE starting up to Day 56 and Day 210 (incl. clinically significant laboratory parameter changes) | Safety Population = study participants with at least one study vaccination | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 56 and Day 210 | | | | ID | Title | Description |
|---|
| OG000 | VLA84 75 mcg (Microgram) w/o Alum | VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B Placebo: phosphate buffered saline (PBS) solution | | OG001 | VLA84 200 mcg w/o Alum | VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B | | OG002 | VLA84 200 mcg With Alum | VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B |
|
| Secondary | Rate of Study Participants With at Least One Related Unsolicited AE | percentage of study participants with at least one related unsolicited AE starting up to Day 56 and Day 210 (incl. clinically significant laboratory parameter changes) | Safety Population = study participants with at least one study vaccination | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 56 and Day 210 | | | | ID | Title | Description |
|---|
| OG000 | VLA84 75 mcg (Microgram) w/o Alum | VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B Placebo: phosphate buffered saline (PBS) solution | | OG001 | VLA84 200 mcg w/o Alum | VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B | | OG002 | VLA84 200 mcg With Alum | VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B |
|
| Secondary | Rates of Study Participants With at Least One Solicited Local and Systemic AE | percentage of study participants with solicited local and systemic AE within 7 days after each and after any vaccination, collected via a subject diary with predefined terms | Safety Population = study participants with at least one study vaccination | Posted | | Number | 95% Confidence Interval | percentage of participants | | within 7 Days after each vaccination | | | | ID | Title | Description |
|---|
| OG000 | VLA84 75 mcg (Microgram) w/o Alum | VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B Placebo: phosphate buffered saline (PBS) solution | | OG001 | VLA84 200 mcg w/o Alum | VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B | | OG002 | VLA84 200 mcg With Alum | VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B |
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| Secondary | Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group | percentage of study participants with at least one SAE, related SAE, unsolicited (unsol.) AE (incl. clinically significant laboratory parameter changes) and related unsolicited AE, starting up to Day 56 and Day 210, stratified by age group (subjects 50 - < 65 years and 65 years and older (65+)) | Safety Population = study participants with at least one study vaccination | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 56 and Day 210 | | | | ID | Title | Description |
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| OG000 | VLA84 75 mcg (Microgram) w/o Alum | VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B Placebo: phosphate buffered saline (PBS) solution | | OG001 | VLA84 200 mcg w/o Alum | VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B | | OG002 | VLA84 200 mcg With Alum |
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| Secondary | Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group | percentage of participants with solicited (sol.) local and systemic AEs within 7 days after each and after any vaccination (vacc.), collected via a subject diary with predefined terms, stratified by age group (subjects 50 - < 65 years and 65 years and older) | Safety Population = study participants with at least one study vaccination | Posted | | Number | 95% Confidence Interval | percentage of participants | | within 7 Days after each vaccination | | | | ID | Title | Description |
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| OG000 | VLA84 75 mcg (Microgram) w/o Alum | VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B Placebo: phosphate buffered saline (PBS) solution | | OG001 | VLA84 200 mcg w/o Alum | VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B | | OG002 | VLA84 200 mcg With Alum |
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