Pneumococcal Infections
Conditions
Brief summary
The purpose of this study is to evaluate the safety and immunogenicity of sequential administration of Prevnar 13™ and Pneumovax™ 23 in healthy participants 50 years of age and older. The primary hypotheses in the study are that 1) geometric mean titers (GMTs) to pneumococcal serotypes 22F and 33F (serotypes in Pneumovax™ 23 but not in Prevnar 13™) as measured at Week 12 are superior in participants administered Prevnar 13™ on Day 1 and Pneumovax™ 23 at Week 8, as compared with participants administered Prevnar 13™ on Day 1 and placebo at Week 8 and 2) GMTs to pneumococcal serotypes shared by the two vaccines as measured at Week 12 are non-inferior in participants administered Prevnar 13™ followed by Pneumovax™ 23 as compared with participants administered Prevnar 13™ followed by placebo.
Interventions
BIOLOGICALPrevnar 13™
Pneumococcal vaccine containing serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. Injections are to be administered into the deltoid muscle of the upper arm.
BIOLOGICALPneumovax™ 23
Pneumococcal vaccine containing 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. Injections are to be administered into the deltoid muscle of the upper arm.
BIOLOGICALPlacebo
Injections are to be administered into the deltoid muscle of the upper arm.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Any chronic illness must be documented to be in stable condition * Male, or a female agrees to remain abstinent, or use, or have their partner use, 2 acceptable methods of contraception through 6 weeks after receiving study vaccination; or a female who is not of reproductive potential
Exclusion criteria
* Is or has an immediate family member who is investigational site or sponsor staff directly involved with this trial * Prior administration of any pneumococcal vaccine * History of invasive pneumococcal disease * Known hypersensitivity to any component of the pneumococcal polysaccharide vaccine, of the pneumococcal conjugate vaccine, or any diphtheria toxoid-containing vaccine * Known or suspected impairment of immunological function, documented Human Immunodeficiency Virus (HIV) infection, asplenia, or history of autoimmune disease * Received systemic corticosteroids (equivalent of \>=2 mg/kg total daily dose of prednisone or \>=20 mg/kg for persons weighing \>10 kg) for \>=14 consecutive days and has not completed treatment \<=30 days before study vaccination, or has received systemic corticosteroids exceeding physiological doses (\ 5 mg/day prednisone equivalent) within 14 days before study vaccination (topical, ophthalmic, intra-articular, and inhaled/nebulized steroids are permitted). * Has a coagulation disorder contraindicating intramuscular vaccination * Receiving immunosuppressive therapy, including chemotherapeutic agents used to treat cancer or other conditions, and treatments associated with organ or bone marrow transplantation or autoimmune disease * Received a blood transfusion or blood products, including immunoglobulins \<=6 months before receiving study vaccine, or is scheduled to receive them within 30 days * Participated in another clinical study of an investigational product \<=2 months before or during the current study * Is breast-feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, at Week 12 | 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 13™ and PNEUMOVAX™ 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. |
| Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE) or Vaccine-related Death | Up to 30 weeks | 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. |
| Percentage of Participants Who Discontinued Vaccination Due to an Adverse Event | Up to 26 weeks | 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. |
| Geometric Mean Titers to Pneumococcal Serotypes 22F and 33F at Week 12 | Week 12 | Vaccine-induced functional antibodies to serotypes 22F and 33F, which are unique to PNEUMOVAX™ 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. |
| Percentage of Participants With an Adverse Event (AE) | Up to 14 days after any vaccination (Up to 28 weeks) | 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. |
| Percentage of Participants With an Injection-site Adverse Event | Up to 14 days after any vaccination (Up to 28 weeks) | An injection site adverse event (AE) includes the following AEs at the injection site: redness, swelling, and pain/tenderness. |
| Percentage of Participants With a Systemic Adverse Event | Up to 14 days after any vaccination (Up to 28 weeks) | Systemic adverse events (AEs) include, but are not restricted to the following AE terms: muscle pain, joint pain, headache, and tiredness. |
| Percentage of Participants With a Serious Adverse Event (SAE) | Up to 30 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 200 |
| 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. | 200 |
| Total | 400 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 5 | 5 |
| Overall Study | Lost to Follow-up | 5 | 5 |
| Overall Study | Non-Compliance With Study Drug | 1 | 0 |
| Overall Study | Participant Moved | 1 | 0 |
| Overall Study | Physician Decision | 2 | 0 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 13 | 28 |
Baseline characteristics
| Characteristic | Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | Total | Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo |
|---|---|---|---|
| Age, Continuous | 64.2 Years STANDARD_DEVIATION 8.9 | 64.2 Years STANDARD_DEVIATION 8.7 | 64.1 Years STANDARD_DEVIATION 8.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 35 Participants | 75 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 164 Participants | 322 Participants | 158 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 23 Participants | 37 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 8 Participants | 15 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 163 Participants | 339 Participants | 176 Participants |
| Sex: Female, Male Female | 107 Participants | 219 Participants | 112 Participants |
| Sex: Female, Male Male | 93 Participants | 181 Participants | 88 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 200 | 0 / 200 |
| other Total, other adverse events | 177 / 200 | 165 / 200 |
| serious Total, serious adverse events | 9 / 200 | 11 / 200 |
Outcome results
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 13™ and PNEUMOVAX™ 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.
Time frame: Week 12
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, at Week 12 | Serotype 1 | 81.7 Titer |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, at Week 12 | Serotype 3 | 43.4 Titer |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, at Week 12 | Serotype 4 | 1079.3 Titer |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, at Week 12 | Serotype 5 | 198.6 Titer |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, at Week 12 | Serotype 6B | 1956.9 Titer |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, at Week 12 | Serotype 7F | 2250.8 Titer |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, at Week 12 | Serotype 9V | 1472.3 Titer |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, at Week 12 | Serotype 14 | 2106.8 Titer |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, at Week 12 | Serotype 18C | 2101.9 Titer |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, at Week 12 | Serotype 19A | 1785.8 Titer |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, at Week 12 | Serotype 19F | 1051.0 Titer |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, at Week 12 | Serotype 23F | 1155.6 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, at Week 12 | Serotype 19F | 627.2 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, at Week 12 | Serotype 1 | 57.1 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, at Week 12 | Serotype 9V | 1017.6 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, at Week 12 | Serotype 3 | 17.5 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, at Week 12 | Serotype 19A | 1425.9 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, at Week 12 | Serotype 4 | 780.0 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, at Week 12 | Serotype 14 | 1945.0 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, at Week 12 | Serotype 5 | 148.4 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, at Week 12 | Serotype 23F | 716.9 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, at Week 12 | Serotype 6B | 1148.1 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, at Week 12 | Serotype 18C | 1587.1 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, at Week 12 | Serotype 7F | 1751.8 Titer |
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 PNEUMOVAX™ 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.
Time frame: Week 12
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | Geometric Mean Titers to Pneumococcal Serotypes 22F and 33F at Week 12 | Serotype 22F | 1766.3 Titer |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | Geometric Mean Titers to Pneumococcal Serotypes 22F and 33F at Week 12 | Serotype 33F | 10413.0 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | Geometric Mean Titers to Pneumococcal Serotypes 22F and 33F at Week 12 | Serotype 22F | 39.0 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | Geometric Mean Titers to Pneumococcal Serotypes 22F and 33F at Week 12 | Serotype 33F | 1189.9 Titer |
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.
Time frame: Up to 26 weeks
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | Percentage of Participants Who Discontinued Vaccination Due to an Adverse Event | 2.5 Percentage of participants |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | Percentage of Participants Who Discontinued Vaccination Due to an Adverse Event | 2.5 Percentage of participants |
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.
Time frame: Up to 14 days after any vaccination (Up to 28 weeks)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | Percentage of Participants With an Adverse Event (AE) | 89.9 Percentage of participants |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | Percentage of Participants With an Adverse Event (AE) | 84.4 Percentage of participants |
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.
Time frame: Up to 14 days after any vaccination (Up to 28 weeks)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | Percentage of Participants With an Injection-site Adverse Event | 86.4 Percentage of participants |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | Percentage of Participants With an Injection-site Adverse Event | 77.9 Percentage of participants |
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.
Time frame: Up to 30 weeks
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | Percentage of Participants With a Serious Adverse Event (SAE) | 4.5 Percentage of participants |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | Percentage of Participants With a Serious Adverse Event (SAE) | 5.5 Percentage of participants |
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.
Time frame: Up to 14 days after any vaccination (Up to 28 weeks)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | Percentage of Participants With a Systemic Adverse Event | 76.8 Percentage of participants |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | Percentage of Participants With a Systemic Adverse Event | 74.4 Percentage of participants |
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.
Time frame: Up to 30 weeks
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE) or Vaccine-related Death | 0 Percentage of participants |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE) or Vaccine-related Death | 0 Percentage of participants |
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.
Time frame: Week 26
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | 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 | Serotype 6A | 1843.2 Titer |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | 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 | Serotype 14 | 1458.2 Titer |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | 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 | Serotype 3 | 19.6 Titer |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | 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 | Serotype 18C | 914.2 Titer |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | 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 | Serotype 6B | 1157.0 Titer |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | 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 | Serotype 19A | 1024.3 Titer |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | 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 | Serotype 5 | 114.4 Titer |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | 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 | Serotype 19F | 563.7 Titer |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | 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 | Serotype 7F | 1204.9 Titer |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | 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 | Serotype 22F | 1228.3 Titer |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | 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 | Serotype 4 | 737.1 Titer |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | 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 | Serotype 23F | 653.8 Titer |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | 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 | Serotype 9V | 698.2 Titer |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | 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 | Serotype 33F | 4672.8 Titer |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | 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 | Serotype 1 | 39.7 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | 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 | Serotype 33F | 1151.4 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | 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 | Serotype 1 | 18.9 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | 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 | Serotype 3 | 9.2 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | 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 | Serotype 4 | 788.4 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | 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 | Serotype 5 | 65.6 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | 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 | Serotype 6A | 1152.9 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | 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 | Serotype 6B | 1125.1 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | 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 | Serotype 7F | 770.7 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | 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 | Serotype 9V | 806.5 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | 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 | Serotype 14 | 1373.9 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | 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 | Serotype 18C | 691.1 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | 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 | Serotype 19A | 806.3 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | 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 | Serotype 19F | 228.9 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | 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 | Serotype 22F | 45.2 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | 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 | Serotype 23F | 366.6 Titer |
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.
Time frame: Week 30
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | 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 | Serotype 6A | 1673.9 Titer |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | 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 | Serotype 14 | 1762.9 Titer |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | 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 | Serotype 3 | 13.9 Titer |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | 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 | Serotype 18C | 779.3 Titer |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | 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 | Serotype 6B | 1330.3 Titer |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | 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 | Serotype 19A | 845.5 Titer |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | 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 | Serotype 5 | 81.5 Titer |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | 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 | Serotype 19F | 349.1 Titer |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | 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 | Serotype 7F | 877.7 Titer |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | 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 | Serotype 22F | 1124.7 Titer |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | 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 | Serotype 4 | 803.6 Titer |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | 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 | Serotype 23F | 574.3 Titer |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | 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 | Serotype 9V | 628.9 Titer |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | 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 | Serotype 33F | 5917.9 Titer |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | 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 | Serotype 1 | 36.0 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | 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 | Serotype 33F | 7853.5 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | 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 | Serotype 1 | 43.4 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | 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 | Serotype 3 | 32.8 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | 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 | Serotype 4 | 1060.0 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | 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 | Serotype 5 | 117.3 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | 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 | Serotype 6A | 1782.7 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | 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 | Serotype 6B | 1343.6 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | 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 | Serotype 7F | 1248.4 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | 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 | Serotype 9V | 1134.8 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | 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 | Serotype 14 | 1963.3 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | 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 | Serotype 18C | 1125.6 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | 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 | Serotype 19A | 1256.1 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | 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 | Serotype 19F | 880.8 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | 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 | Serotype 22F | 982.1 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | 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 | Serotype 23F | 755.6 Titer |
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.
Time frame: Week 8
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | 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 | Serotype 6A | 3945.3 Titer |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | 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 | Serotype 14 | 2417.0 Titer |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | 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 | Serotype 3 | 52.8 Titer |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | 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 | Serotype 18C | 1890.8 Titer |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | 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 | Serotype 6B | 2154.2 Titer |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | 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 | Serotype 19A | 2102.3 Titer |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | 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 | Serotype 5 | 350.5 Titer |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | 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 | Serotype 19F | 1039.4 Titer |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | 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 | Serotype 7F | 3830.5 Titer |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | 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 | Serotype 22F | 116.4 Titer |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | 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 | Serotype 4 | 1075.7 Titer |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | 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 | Serotype 23F | 1245.8 Titer |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | 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 | Serotype 9V | 1555.6 Titer |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | 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 | Serotype 33F | 1515.4 Titer |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | 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 | Serotype 1 | 100.7 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | 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 | Serotype 33F | 1984.0 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | 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 | Serotype 1 | 54.7 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | 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 | Serotype 3 | 27.8 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | 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 | Serotype 4 | 1051.0 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | 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 | Serotype 5 | 143.9 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | 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 | Serotype 6A | 4024.1 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | 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 | Serotype 6B | 1259.7 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | 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 | Serotype 7F | 2064.0 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | 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 | Serotype 9V | 1606.5 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | 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 | Serotype 14 | 1586.4 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | 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 | Serotype 18C | 1563.7 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | 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 | Serotype 19A | 1819.8 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | 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 | Serotype 19F | 640.4 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | 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 | Serotype 22F | 30.9 Titer |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | 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 | Serotype 23F | 779.8 Titer |