| Primary | Percentage of Participants With an Adverse Event (AE) | An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. | Participants who received at least 1 dose of treatment and followed up for safety. Two participants from Group 1, and 1 participant from Group 2 were not analyzed due to lack of follow-up data. As the objective was to report the combined safety of the two vaccines given 8 or 26 weeks apart, results are presented for the sequence of vaccinations. | Posted | | Number | | Percentage of participants | | Up to 14 days after any vaccination (Up to 28 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Pneumovax™ 23 0.5 mL intramuscular injection at Week 8, and Placebo 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs. | | OG001 | Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Placebo 0.5 mL intramuscular injection at Week 8, and Pneumovax™ 23 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs. |
| | | Title | Denominators | Categories |
|---|
| | |
| |
| Primary | Percentage of Participants With an Injection-site Adverse Event | An injection site adverse event (AE) includes the following AEs at the injection site: redness, swelling, and pain/tenderness. | Participants who received at least 1 dose of treatment and followed up for safety. Two participants from Group 1, and 1 participant from Group 2 were not analyzed due to lack of follow-up data. As the objective was to report the combined safety of the two vaccines given 8 or 26 weeks apart, results are presented for the sequence of vaccinations. | Posted | | Number | | Percentage of participants | | Up to 14 days after any vaccination (Up to 28 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Pneumovax™ 23 0.5 mL intramuscular injection at Week 8, and Placebo 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs. | | OG001 | Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Placebo 0.5 mL intramuscular injection at Week 8, and Pneumovax™ 23 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs. |
| |
| Primary | Percentage of Participants With a Systemic Adverse Event | Systemic adverse events (AEs) include, but are not restricted to the following AE terms: muscle pain, joint pain, headache, and tiredness. | Participants who received at least 1 dose of treatment and followed up for safety. Two participants from Group 1, and 1 participant from Group 2 were not analyzed due to lack of follow-up data. As the objective was to report the combined safety of the two vaccines given 8 or 26 weeks apart, results are presented for the sequence of vaccinations. | Posted | | Number | | Percentage of participants | | Up to 14 days after any vaccination (Up to 28 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Pneumovax™ 23 0.5 mL intramuscular injection at Week 8, and Placebo 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs. | | OG001 | Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Placebo 0.5 mL intramuscular injection at Week 8, and Pneumovax™ 23 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs. |
| |
| Primary | Percentage of Participants With a Serious Adverse Event (SAE) | A serious adverse event (SAE) is any adverse event occurring at any dose or during any use of Sponsor's product that: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is another important medical event; is a cancer; or is associated with an overdose. | Participants who received at least 1 dose of treatment and followed up for safety. Two participants from Group 1, and 1 participant from Group 2 were not analyzed due to lack of follow-up data. As the objective was to report the combined safety of the two vaccines given 8 or 26 weeks apart, results are presented for the sequence of vaccinations. | Posted | | Number | | Percentage of participants | | Up to 30 weeks | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Pneumovax™ 23 0.5 mL intramuscular injection at Week 8, and Placebo 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs. | | OG001 | Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Placebo 0.5 mL intramuscular injection at Week 8, and Pneumovax™ 23 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs. |
|
| Primary | Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE) or Vaccine-related Death | A serious adverse event (SAE) is any adverse event occurring at any dose or during any use of Sponsor's product that: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is another important medical event; is a cancer; or is associated with an overdose. The investigator determined whether the SAE or death was related to vaccine treatment. | Participants who received at least 1 dose of treatment and followed up for safety. Two participants from Group 1, and 1 participant from Group 2 were not analyzed due to lack of follow-up data. As the objective was to report the combined safety of the two vaccines given 8 or 26 weeks apart, results are presented for the sequence of vaccinations. | Posted | | Number | | Percentage of participants | | Up to 30 weeks | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Pneumovax™ 23 0.5 mL intramuscular injection at Week 8, and Placebo 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs. | | OG001 | Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Placebo 0.5 mL intramuscular injection at Week 8, and Pneumovax™ 23 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs. |
|
| Primary | Percentage of Participants Who Discontinued Vaccination Due to an Adverse Event | An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. | Participants who received at least 1 dose of treatment and followed up for safety. Two participants from Group 1, and 1 participant from Group 2 were not analyzed due to lack of follow-up data. As the objective was to report the combined safety of the two vaccines given 8 or 26 weeks apart, results are presented for the sequence of vaccinations. | Posted | | Number | | Percentage of participants | | Up to 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Pneumovax™ 23 0.5 mL intramuscular injection at Week 8, and Placebo 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs. | | OG001 | Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 |
|
| Primary | Geometric Mean Titers to Pneumococcal Serotypes 22F and 33F at Week 12 | Vaccine-induced functional antibodies to serotypes 22F and 33F, which are unique to PNEUMOVAXâ„¢ 23, were measured by the multiplex opsonophagocytic activity 4 (MOPA-4) assay, which is based on the ability of antibody in the serum to initiate killing of bacterial pneumococci. | All randomized participants who received at least 1 vaccination and provided serology data for the particular serotype tested; with appropriate day ranges for vaccinations and blood draws, and excludes participants with important deviations from the protocol that may substantially affect the results. | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Pneumovax™ 23 0.5 mL intramuscular injection at Week 8, and Placebo 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs. | | OG001 | Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Placebo 0.5 mL intramuscular injection at Week 8, and Pneumovax™ 23 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs. |
| |
| Primary | Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, at Week 12 | Vaccine-induced functional antibodies to serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, which are contained in both Prevnar 13â„¢ and PNEUMOVAXâ„¢ 23, were measured by the MOPA-4 assay, which is based on the ability of antibody in the serum to initiate killing of bacterial pneumococci. | All randomized participants who received at least 1 vaccination and provided serology data for the particular serotype tested; with appropriate day ranges for vaccinations and blood draws, and excludes participants with important deviations from the protocol that may substantially affect the results. | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Pneumovax™ 23 0.5 mL intramuscular injection at Week 8, and Placebo 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs. | | OG001 | Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Placebo 0.5 mL intramuscular injection at Week 8, and Pneumovax™ 23 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs. |
| |
| Secondary | Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F at Week 8 | Vaccine-induced functional antibodies were measured by the MOPA-4 assay, which is based on the ability of antibody in the serum to initiate killing of bacterial pneumococci. | All randomized participants who received at least 1 vaccination and provided serology data for the particular serotype tested; with appropriate day ranges for vaccinations and blood draws, and excludes participants with important deviations from the protocol that may substantially affect the results. | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Pneumovax™ 23 0.5 mL intramuscular injection at Week 8, and Placebo 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs. | | OG001 | Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Placebo 0.5 mL intramuscular injection at Week 8, and Pneumovax™ 23 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs. |
| |
| Secondary | Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F at Week 26 | Vaccine-induced functional antibodies were measured by the MOPA-4 assay, which is based on the ability of antibody in the serum to initiate killing of bacterial pneumococci. | All randomized participants who received at least 1 vaccination and provided serology data for the particular serotype tested; with appropriate day ranges for vaccinations and blood draws, and excludes participants with important deviations from the protocol that may substantially affect the results. | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Pneumovax™ 23 0.5 mL intramuscular injection at Week 8, and Placebo 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs. | | OG001 | Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Placebo 0.5 mL intramuscular injection at Week 8, and Pneumovax™ 23 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs. |
| |
| Secondary | Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F at Week 30 | Vaccine-induced functional antibodies were measured by the MOPA-4 assay, which is based on the ability of antibody in the serum to initiate killing of bacterial pneumococci. | All randomized participants who received at least 1 vaccination and provided serology data for the particular serotype tested; with appropriate day ranges for vaccinations and blood draws, and excludes participants with important deviations from the protocol that may substantially affect the results. | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | Week 30 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Pneumovax™ 23 0.5 mL intramuscular injection at Week 8, and Placebo 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs. | | OG001 | Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Placebo 0.5 mL intramuscular injection at Week 8, and Pneumovax™ 23 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs. |
| |