Pneumococcal Infections
Conditions
Brief summary
This is a 2-stage, phase 1/2, randomized, active-controlled, observer-blinded study with a 2-arm parallel design in each stage. In Stage 1 healthy adults 50 to 64 years of age with no history of pneumococcal vaccination will be randomized equally to receive either a single intramuscular dose of multivalent pneumococcal conjugate vaccine or a licensed tetanus, diphtheria, acellular pertussis combination vaccine (Tdap) (control group). In Stage 2 healthy adults 65 to 85 years of age previously vaccinated with Prevnar 13 \>=2 months prior to investigational product administration will be randomized equally to receive either a single intramuscular dose of multivalent pneumococcal conjugate vaccine or the licensed 23-valent pneumococcal polysaccharide vaccine (control group).
Interventions
BIOLOGICALMultivalent
Pneumococcal conjugate vaccine
BIOLOGICALTdap
Tetanus, diphtheria, acellular pertussis vaccine
BIOLOGICALpolysaccharide
23-valent pneumococcal polysaccharide vaccine
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Observer-blinded
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Stage 1: Healthy male or female adults 50 to 64 years of age with no history of pneumococcal vaccination * Stage 2: Healthy male or female adults 65 to 85 years of age previously vaccinated with Prevnar 13 \>= 2 months prior to investigational product administration
Exclusion criteria
* Stage 1: Vaccination within 12 months before investigational product administration with diphtheria-, pertussis-, or tetanus-containing vaccine * Stage 2: Previous vaccination with any pneumococcal vaccine other than a single prior dose of Prevnar 13
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stage 2: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 12 Months After Vaccination | within 12 months after vaccination | An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects. |
| Stage 2: Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination | within 6 months after vaccination | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. |
| Stage 1: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination | within 6 months after vaccination | An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects. |
| Stage 2: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination | within 6 months after vaccination | An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects. |
| Stage 2: Percentage of Participants With Serious Adverse Events (SAEs) Within 12 Months After Vaccination | within 12 months after vaccination | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. |
| Stage 1: Percentage of Participants With Local Reactions Within 14 Days After Vaccination | within 14 days after vaccination | Local reactions included pain at injection site, swelling and redness recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild: greater than (\>) 2.0 to 5.0 cm, moderate: \>5.0 to 10.0 cm and severe: \>10.0 cm. Pain at injection site was graded as mild: did not interfere with activity, moderate: interfered with activity and severe: prevented daily activity. |
| Stage 2: Percentage of Participants With Local Reactions Within 14 Days After Vaccination | within 14 days after vaccination | Local reactions included pain at injection site, swelling and redness recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild: \>2.0 to 5.0 cm, moderate: \>5.0 to 10.0 cm and severe: \>10.0 cm. Pain at injection site was graded as mild: did not interfere with activity, moderate: interfered with activity and severe: prevented daily activity. |
| Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | within 14 days after vaccination | Systemic events included fever, fatigue, headache, muscle pain and joint pain recorded by participants in an e-diary. Fever was categorized as: \>=38.0 degrees Celsius (C), \>=38.0 to 38.4 degrees C, \>38.4 to 38.9 degrees C, \>38.9 to 40.0 degrees C and \>40.0 degrees C. Fatigue, headache, muscle pain and joint pain were graded as any, mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. |
| Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | within 14 days after vaccination | Systemic events included fever, fatigue, headache, muscle pain and joint pain recorded by participants in an e-diary. Fever was categorized as: \>=38.0 degrees C, \>=38.0 to 38.4 degrees C, \>38.4 to 38.9 degrees C, \>38.9 to 40.0 degrees C and \>40.0 degrees C. Fatigue, headache, muscle pain and joint pain were graded as any, mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. |
| Stage 1: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination | within 1 month after vaccination | An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both AEs and Non-SAEs. |
| Stage 2: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination | within 1 month after vaccination | An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both AEs and Non-SAEs. |
| Stage 1: Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination | within 6 months after vaccination | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stage 2: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Vaccination | within 1 month after vaccination | Antibody-mediated serum OPA against the 7 common pneumococcal serotypes specific to c7vPnC (serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F) were measured using a pneumococcal OPA assay. Results were expressed as OPA GMTs. Assay results below the LLOQ were set to 0.5\*LLOQ in the analysis. |
| Stage 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) From Pre-vaccination to 1 Month After Vaccination | before Vaccination to 1 month after Vaccination | GMFR for the 7 pneumococcal serotypes (serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F) from before Vaccination to one month after Vaccination. Assay results below the LLOQ were set to 0.5\*LLOQ in the analysis. |
| Stage 2: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) From Pre-Vaccination to 1 Month After Vaccination | before Vaccination to 1 month after Vaccination | GMFR for the 7 pneumococcal serotypes (serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F) from before Vaccination to one month after Vaccination. Assay results below the LLOQ were set to 0.5\*LLOQ in the analysis. |
| Stage 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Vaccination | 1 month after vaccination | Antibody-mediated serum OPA against the 7 pneumococcal serotypes specific to c7vPnC (serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F) were measured using a pneumococcal OPA assay. Results were expressed as OPA GMTs. Assay results below the lower limit of quantitation (LLOQ) were set to 0.5\*LLOQ in the analysis. Evaluable immunogenicity population = EIP. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Stage 1: c7vPnC (50 to 64 Years of Age) In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1. Participants were followed up to 6 months after vaccination. | 34 |
| Stage 1: Tdap (50 to 64 Years of Age) In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of tetanus, diphtheria, and acellular pertussis vaccine (Tdap) as control vaccine on Day 1. Participants were followed up to 6 months after vaccination. | 32 |
| Stage 2: c7vPnC (65 to 85 Years of Age) In Stage 2 healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination. | 221 |
| Stage 2: PPSV23 (65 to 85 Years of Age) In Stage 2, healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23 ) as control vaccine on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination. | 223 |
| Total | 510 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Stage 2: 12 Months | Adverse Event | 0 | 0 | 0 | 1 |
| Stage 2: 12 Months | Death | 0 | 0 | 3 | 0 |
| Stage 2: 12 Months | Lost to Follow-up | 0 | 0 | 1 | 5 |
| Stage 2: 12 Months | No Longer Meets Eligibility Criteria | 0 | 0 | 0 | 3 |
| Stage 2: 12 Months | Other | 0 | 0 | 0 | 1 |
| Stage 2: 12 Months | Protocol deviation | 0 | 0 | 7 | 7 |
| Stage 2: 12 Months | Withdrawal by Subject | 0 | 0 | 0 | 3 |
Baseline characteristics
| Characteristic | Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Tdap (50 to 64 Years of Age) | Stage 2: c7vPnC (65 to 85 Years of Age) | Stage 2: PPSV23 (65 to 85 Years of Age) | Total |
|---|---|---|---|---|---|
| Age, Continuous | 58.2 Years STANDARD_DEVIATION 4.52 | 58.1 Years STANDARD_DEVIATION 4.46 | 68.9 Years STANDARD_DEVIATION 4.72 | 68.8 Years STANDARD_DEVIATION 3.97 | 67.5 Years STANDARD_DEVIATION 5.66 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 4 Participants | 10 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 34 Participants | 30 Participants | 216 Participants | 213 Participants | 493 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 6 Participants | 4 Participants | 10 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 11 Participants | 9 Participants | 21 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 34 Participants | 31 Participants | 204 Participants | 210 Participants | 479 Participants |
| Sex: Female, Male Female | 23 Participants | 21 Participants | 131 Participants | 135 Participants | 310 Participants |
| Sex: Female, Male Male | 11 Participants | 11 Participants | 90 Participants | 88 Participants | 200 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 32 | 3 / 221 | 0 / 223 |
| other Total, other adverse events | 27 / 34 | 28 / 32 | 161 / 221 | 171 / 223 |
| serious Total, serious adverse events | 2 / 34 | 0 / 32 | 9 / 221 | 8 / 223 |
Outcome results
Primary
Stage 1: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both AEs and Non-SAEs.
Time frame: within 1 month after vaccination
Population: The safety population of Stage 1 included all participants who received at least 1 dose of c7vPnC or Tdap and had post-vaccination follow-up in Stage 1 and participants who lacked any safety data were excluded from the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination | 8.8 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination | 9.4 percentage of participants |
Primary
Stage 1: Percentage of Participants With Local Reactions Within 14 Days After Vaccination
Local reactions included pain at injection site, swelling and redness recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild: greater than (\>) 2.0 to 5.0 cm, moderate: \>5.0 to 10.0 cm and severe: \>10.0 cm. Pain at injection site was graded as mild: did not interfere with activity, moderate: interfered with activity and severe: prevented daily activity.
Time frame: within 14 days after vaccination
Population: The safety population of Stage 1 included all participants who received at least 1 dose of c7vPnC or Tdap and had post-vaccination follow-up in Stage 1 and participants who lacked any safety data were excluded from the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Local Reactions Within 14 Days After Vaccination | Redness: Any | 2.9 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Local Reactions Within 14 Days After Vaccination | Redness: Mild | 2.9 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Local Reactions Within 14 Days After Vaccination | Redness: Moderate | 0 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Local Reactions Within 14 Days After Vaccination | Redness: Severe | 0 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Local Reactions Within 14 Days After Vaccination | Swelling: Any | 8.8 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Local Reactions Within 14 Days After Vaccination | Swelling: Mild | 5.9 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Local Reactions Within 14 Days After Vaccination | Swelling: Moderate | 2.9 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Local Reactions Within 14 Days After Vaccination | Swelling: Severe | 0 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Local Reactions Within 14 Days After Vaccination | Pain at injection site: Any | 64.7 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Local Reactions Within 14 Days After Vaccination | Pain at injection site: Mild | 50.0 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Local Reactions Within 14 Days After Vaccination | Pain at injection site: Moderate | 14.7 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Local Reactions Within 14 Days After Vaccination | Pain at injection site: Severe | 0 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Local Reactions Within 14 Days After Vaccination | Pain at injection site: Moderate | 12.5 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Local Reactions Within 14 Days After Vaccination | Redness: Any | 12.5 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Local Reactions Within 14 Days After Vaccination | Swelling: Moderate | 12.5 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Local Reactions Within 14 Days After Vaccination | Redness: Mild | 6.3 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Local Reactions Within 14 Days After Vaccination | Pain at injection site: Mild | 59.4 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Local Reactions Within 14 Days After Vaccination | Redness: Moderate | 6.3 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Local Reactions Within 14 Days After Vaccination | Swelling: Severe | 0 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Local Reactions Within 14 Days After Vaccination | Redness: Severe | 0 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Local Reactions Within 14 Days After Vaccination | Pain at injection site: Severe | 0 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Local Reactions Within 14 Days After Vaccination | Swelling: Any | 18.8 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Local Reactions Within 14 Days After Vaccination | Pain at injection site: Any | 71.9 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Local Reactions Within 14 Days After Vaccination | Swelling: Mild | 6.3 percentage of participants |
Primary
Stage 1: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination
An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects.
Time frame: within 6 months after vaccination
Population: The safety population of Stage 1 included all participants who received at least 1 dose of c7vPnC or Tdap and had post-vaccination follow-up in Stage 1 and participants who lacked any safety data were excluded from the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination | 0 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination | 6.3 percentage of participants |
Primary
Stage 1: Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: within 6 months after vaccination
Population: The safety population of Stage 1 included all participants who received at least 1 dose of c7vPnC or Tdap and had post-vaccination follow-up in Stage 1 and participants who lacked any safety data were excluded from the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination | 5.9 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination | 0 percentage of participants |
Primary
Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination
Systemic events included fever, fatigue, headache, muscle pain and joint pain recorded by participants in an e-diary. Fever was categorized as: \>=38.0 degrees Celsius (C), \>=38.0 to 38.4 degrees C, \>38.4 to 38.9 degrees C, \>38.9 to 40.0 degrees C and \>40.0 degrees C. Fatigue, headache, muscle pain and joint pain were graded as any, mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity.
Time frame: within 14 days after vaccination
Population: The safety population of Stage 1 included all participants who received at least 1 dose of c7vPnC or Tdap and had post-vaccination follow-up in Stage 1 and participants who lacked any safety data were excluded from the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Headache: Mild | 23.5 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Fatigue: Any | 29.4 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Muscle pain: Any | 38.2 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Fatigue: Mild | 29.4 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Fever: >=38.0 degree C | 0 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Fatigue: Moderate | 0 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Headache: Any | 38.2 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Muscle pain: Mild | 26.5 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Fever: >=38.0 to 38.4 degree C | 0 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Muscle pain: Moderate | 11.8 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Headache: Moderate | 14.7 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Muscle pain: Severe | 0 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Fever: >38.4 to 38.9 degree C | 0 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Joint pain: Any | 11.8 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Fatigue: Severe | 0 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Joint pain: Mild | 11.8 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Fever: >38.9 to 40.0 degree C | 0 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Joint pain: Moderate | 0 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Headache: Severe | 0 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Joint pain: Severe | 0 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Fever: >40.0 degree C | 0 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Joint pain: Severe | 0 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Fatigue: Severe | 0 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Headache: Any | 34.4 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Headache: Mild | 18.8 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Headache: Moderate | 15.6 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Headache: Severe | 0 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Fever: >=38.0 degree C | 0 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Fever: >=38.0 to 38.4 degree C | 0 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Fever: >38.4 to 38.9 degree C | 0 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Fever: >38.9 to 40.0 degree C | 0 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Fever: >40.0 degree C | 0 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Fatigue: Any | 28.1 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Fatigue: Mild | 9.4 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Muscle pain: Any | 56.3 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Muscle pain: Mild | 43.8 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Muscle pain: Moderate | 12.5 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Muscle pain: Severe | 0 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Joint pain: Any | 15.6 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Joint pain: Mild | 12.5 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Joint pain: Moderate | 3.1 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Fatigue: Moderate | 18.8 percentage of participants |
Primary
Stage 2: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both AEs and Non-SAEs.
Time frame: within 1 month after vaccination
Population: The safety population of Stage 2 included all participants who received at least 1 dose of c7vPnC or PPSV23 and had post-vaccination follow-up in Stage 2 and participants who lacked any safety data were excluded from the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination | 10.0 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination | 13.5 percentage of participants |
Primary
Stage 2: Percentage of Participants With Local Reactions Within 14 Days After Vaccination
Local reactions included pain at injection site, swelling and redness recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild: \>2.0 to 5.0 cm, moderate: \>5.0 to 10.0 cm and severe: \>10.0 cm. Pain at injection site was graded as mild: did not interfere with activity, moderate: interfered with activity and severe: prevented daily activity.
Time frame: within 14 days after vaccination
Population: The safety population of Stage 2 included all participants who received at least 1 dose of c7vPnC or PPSV23 and had post-vaccination follow-up in Stage 2 and participants who lacked any safety data were excluded from the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Local Reactions Within 14 Days After Vaccination | Redness: Any | 8.1 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Local Reactions Within 14 Days After Vaccination | Redness: Mild | 5.9 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Local Reactions Within 14 Days After Vaccination | Redness: Moderate | 2.3 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Local Reactions Within 14 Days After Vaccination | Redness: Severe | 0 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Local Reactions Within 14 Days After Vaccination | Swelling: Any | 6.8 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Local Reactions Within 14 Days After Vaccination | Swelling: Mild | 5.9 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Local Reactions Within 14 Days After Vaccination | Swelling: Moderate | 0.9 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Local Reactions Within 14 Days After Vaccination | Swelling: Severe | 0 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Local Reactions Within 14 Days After Vaccination | Pain at injection site: Any | 48.4 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Local Reactions Within 14 Days After Vaccination | Pain at injection site: Mild | 46.6 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Local Reactions Within 14 Days After Vaccination | Pain at injection site: Moderate | 1.8 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Local Reactions Within 14 Days After Vaccination | Pain at injection site: Severe | 0 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Local Reactions Within 14 Days After Vaccination | Pain at injection site: Moderate | 14.3 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Local Reactions Within 14 Days After Vaccination | Redness: Any | 17.9 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Local Reactions Within 14 Days After Vaccination | Swelling: Moderate | 7.6 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Local Reactions Within 14 Days After Vaccination | Redness: Mild | 8.1 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Local Reactions Within 14 Days After Vaccination | Pain at injection site: Mild | 44.8 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Local Reactions Within 14 Days After Vaccination | Redness: Moderate | 4.5 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Local Reactions Within 14 Days After Vaccination | Swelling: Severe | 3.6 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Local Reactions Within 14 Days After Vaccination | Redness: Severe | 5.4 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Local Reactions Within 14 Days After Vaccination | Pain at injection site: Severe | 1.8 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Local Reactions Within 14 Days After Vaccination | Swelling: Any | 16.6 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Local Reactions Within 14 Days After Vaccination | Pain at injection site: Any | 61.0 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Local Reactions Within 14 Days After Vaccination | Swelling: Mild | 5.4 percentage of participants |
Primary
Stage 2: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 12 Months After Vaccination
An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects.
Time frame: within 12 months after vaccination
Population: The safety population of Stage 2 included all participants who received at least 1 dose of c7vPnC or PPSV23 and had post-vaccination follow-up in Stage 2 and participants who lacked any safety data were excluded from the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 12 Months After Vaccination | 6.8 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 12 Months After Vaccination | 6.3 percentage of participants |
Primary
Stage 2: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination
An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects.
Time frame: within 6 months after vaccination
Population: The safety population of Stage 2 included all participants who received at least 1 dose of c7vPnC or PPSV23 and had post-vaccination follow-up in Stage 2 and participants who lacked any safety data were excluded from the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination | 3.2 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination | 4.5 percentage of participants |
Primary
Stage 2: Percentage of Participants With Serious Adverse Events (SAEs) Within 12 Months After Vaccination
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: within 12 months after vaccination
Population: The safety population of Stage 2 included all participants who received at least 1 dose of c7vPnC or PPSV23 and had post-vaccination follow-up in Stage 2 and participants who lacked any safety data were excluded from the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Serious Adverse Events (SAEs) Within 12 Months After Vaccination | 4.1 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Serious Adverse Events (SAEs) Within 12 Months After Vaccination | 3.6 percentage of participants |
Primary
Stage 2: Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: within 6 months after vaccination
Population: The safety population of Stage 2 included all participants who received at least 1 dose of c7vPnC or PPSV23 and had post-vaccination follow-up in Stage 2 and participants who lacked any safety data were excluded from the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination | 2.3 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination | 2.7 percentage of participants |
Primary
Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination
Systemic events included fever, fatigue, headache, muscle pain and joint pain recorded by participants in an e-diary. Fever was categorized as: \>=38.0 degrees C, \>=38.0 to 38.4 degrees C, \>38.4 to 38.9 degrees C, \>38.9 to 40.0 degrees C and \>40.0 degrees C. Fatigue, headache, muscle pain and joint pain were graded as any, mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity.
Time frame: within 14 days after vaccination
Population: The safety population of Stage 2 included all participants who received at least 1 dose of c7vPnC or PPSV23 and had post-vaccination follow-up in Stage 2 and participants who lacked any safety data were excluded from the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Fever: >=38.0 degree C | 0.5 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Fever: >=38.0 to 38.4 degree C | 0.5 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Muscle pain: Mild | 31.7 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Muscle pain: Moderate | 6.3 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Muscle pain: Severe | 0.5 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Joint pain: Any | 14.9 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Joint pain: Mild | 9.5 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Joint pain: Moderate | 5.4 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Joint pain: Severe | 0 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Headache: Any | 24.4 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Fever: >38.4 to 38.9 degree C | 0 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Fever: >38.9 to 40.0 degree C | 0 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Fever: >40.0 degree C | 0 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Fatigue: Any | 34.4 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Fatigue: Mild | 24.9 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Fatigue: Moderate | 7.7 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Fatigue: Severe | 1.8 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Headache: Mild | 20.4 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Headache: Moderate | 3.6 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Headache: Severe | 0.5 percentage of participants |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Muscle pain: Any | 38.5 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Fever: >38.4 to 38.9 degree C | 0.4 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Fever: >=38.0 degree C | 0.9 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Headache: Severe | 0.4 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Muscle pain: Any | 46.6 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Fever: >38.9 to 40.0 degree C | 0.4 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Muscle pain: Mild | 29.1 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Fatigue: Severe | 1.8 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Muscle pain: Moderate | 16.6 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Fever: >40.0 degree C | 0 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Muscle pain: Severe | 0.9 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Headache: Any | 20.2 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Joint pain: Any | 19.7 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Fatigue: Any | 33.2 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Joint pain: Mild | 12.6 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Headache: Moderate | 5.4 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Joint pain: Moderate | 7.2 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Fatigue: Mild | 17.5 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Joint pain: Severe | 0 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Headache: Mild | 14.3 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Fever: >=38.0 to 38.4 degree C | 0 percentage of participants |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Fatigue: Moderate | 13.9 percentage of participants |
Secondary
Stage 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) From Pre-vaccination to 1 Month After Vaccination
GMFR for the 7 pneumococcal serotypes (serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F) from before Vaccination to one month after Vaccination. Assay results below the LLOQ were set to 0.5\*LLOQ in the analysis.
Time frame: before Vaccination to 1 month after Vaccination
Population: EIP Stage 1:eligible participants with no major protocol deviations, received assigned vaccine, blood collected was within 27-49 days post vaccination, had at least 1 valid and determinate assay result for at least 1 serotype for 1 month after vaccination. Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified rows.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) From Pre-vaccination to 1 Month After Vaccination | Serotype 11A | 6.5 fold rise |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) From Pre-vaccination to 1 Month After Vaccination | Serotype 15B | 100.2 fold rise |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) From Pre-vaccination to 1 Month After Vaccination | Serotype 10A | 64.7 fold rise |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) From Pre-vaccination to 1 Month After Vaccination | Serotype 22F | 58.6 fold rise |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) From Pre-vaccination to 1 Month After Vaccination | Serotype 12F | 261.8 fold rise |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) From Pre-vaccination to 1 Month After Vaccination | Serotype 33F | 27.9 fold rise |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) From Pre-vaccination to 1 Month After Vaccination | Serotype 8 | 106.2 fold rise |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) From Pre-vaccination to 1 Month After Vaccination | Serotype 33F | 0.9 fold rise |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) From Pre-vaccination to 1 Month After Vaccination | Serotype 8 | 1.1 fold rise |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) From Pre-vaccination to 1 Month After Vaccination | Serotype 10A | 1.2 fold rise |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) From Pre-vaccination to 1 Month After Vaccination | Serotype 11A | 1.0 fold rise |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) From Pre-vaccination to 1 Month After Vaccination | Serotype 12F | 1.2 fold rise |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) From Pre-vaccination to 1 Month After Vaccination | Serotype 15B | 1.1 fold rise |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) From Pre-vaccination to 1 Month After Vaccination | Serotype 22F | 1.4 fold rise |
Secondary
Stage 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Vaccination
Antibody-mediated serum OPA against the 7 pneumococcal serotypes specific to c7vPnC (serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F) were measured using a pneumococcal OPA assay. Results were expressed as OPA GMTs. Assay results below the lower limit of quantitation (LLOQ) were set to 0.5\*LLOQ in the analysis. Evaluable immunogenicity population = EIP.
Time frame: 1 month after vaccination
Population: EIP Stage 1:eligible participants with no major protocol deviations, received assigned vaccine, blood collected was within 27-49 days post vaccination, had at least 1 valid and determinate assay result for at least 1 serotype for 1 month after vaccination. 'Number Analyzed' = participants evaluable for this outcome measure at specified rows.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Vaccination | Serotype 11A | 3154 Titer (1/dilution) |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Vaccination | Serotype 15B | 3926 Titer (1/dilution) |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Vaccination | Serotype 10A | 6622 Titer (1/dilution) |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Vaccination | Serotype 22F | 5932 Titer (1/dilution) |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Vaccination | Serotype 12F | 9558 Titer (1/dilution) |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Vaccination | Serotype 33F | 8432 Titer (1/dilution) |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Vaccination | Serotype 8 | 1401 Titer (1/dilution) |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Vaccination | Serotype 33F | 433 Titer (1/dilution) |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Vaccination | Serotype 8 | 16 Titer (1/dilution) |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Vaccination | Serotype 10A | 92 Titer (1/dilution) |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Vaccination | Serotype 11A | 604 Titer (1/dilution) |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Vaccination | Serotype 12F | 90 Titer (1/dilution) |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Vaccination | Serotype 15B | 30 Titer (1/dilution) |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Vaccination | Serotype 22F | 167 Titer (1/dilution) |
Secondary
Stage 2: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) From Pre-Vaccination to 1 Month After Vaccination
GMFR for the 7 pneumococcal serotypes (serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F) from before Vaccination to one month after Vaccination. Assay results below the LLOQ were set to 0.5\*LLOQ in the analysis.
Time frame: before Vaccination to 1 month after Vaccination
Population: EIP Stage 2:eligible participants with no major protocol deviations, received assigned vaccine, blood collected was within 27-49 days post vaccination, had at least 1 valid and determinate assay result for at least 1 serotype for 1 month after vaccination. Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified rows.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 2: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) From Pre-Vaccination to 1 Month After Vaccination | Serotype 11A | 7.5 fold rise |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 2: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) From Pre-Vaccination to 1 Month After Vaccination | Serotype 15B | 31.7 fold rise |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 2: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) From Pre-Vaccination to 1 Month After Vaccination | Serotype 10A | 30.6 fold rise |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 2: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) From Pre-Vaccination to 1 Month After Vaccination | Serotype 22F | 30.0 fold rise |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 2: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) From Pre-Vaccination to 1 Month After Vaccination | Serotype 12F | 64.0 fold rise |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 2: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) From Pre-Vaccination to 1 Month After Vaccination | Serotype 33F | 10.0 fold rise |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 2: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) From Pre-Vaccination to 1 Month After Vaccination | Serotype 8 | 30.2 fold rise |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 2: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) From Pre-Vaccination to 1 Month After Vaccination | Serotype 33F | 8.7 fold rise |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 2: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) From Pre-Vaccination to 1 Month After Vaccination | Serotype 8 | 40.5 fold rise |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 2: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) From Pre-Vaccination to 1 Month After Vaccination | Serotype 10A | 15.2 fold rise |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 2: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) From Pre-Vaccination to 1 Month After Vaccination | Serotype 11A | 7.0 fold rise |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 2: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) From Pre-Vaccination to 1 Month After Vaccination | Serotype 12F | 37.6 fold rise |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 2: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) From Pre-Vaccination to 1 Month After Vaccination | Serotype 15B | 16.4 fold rise |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 2: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) From Pre-Vaccination to 1 Month After Vaccination | Serotype 22F | 18.6 fold rise |
Secondary
Stage 2: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Vaccination
Antibody-mediated serum OPA against the 7 common pneumococcal serotypes specific to c7vPnC (serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F) were measured using a pneumococcal OPA assay. Results were expressed as OPA GMTs. Assay results below the LLOQ were set to 0.5\*LLOQ in the analysis.
Time frame: within 1 month after vaccination
Population: EIP Stage 2:eligible participants with no major protocol deviations, received assigned vaccine, blood collected was within 27-49 days post vaccination, had at least 1 valid and determinate assay result for at least 1 serotype for 1 month after vaccination. Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified rows.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 2: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Vaccination | Serotype 11A | 2290 Titer (1/dilution) |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 2: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Vaccination | Serotype 15B | 1381 Titer (1/dilution) |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 2: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Vaccination | Serotype 10A | 2297 Titer (1/dilution) |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 2: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Vaccination | Serotype 22F | 4775 Titer (1/dilution) |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 2: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Vaccination | Serotype 12F | 3684 Titer (1/dilution) |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 2: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Vaccination | Serotype 33F | 4250 Titer (1/dilution) |
| Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 2: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Vaccination | Serotype 8 | 528 Titer (1/dilution) |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 2: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Vaccination | Serotype 33F | 4043 Titer (1/dilution) |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 2: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Vaccination | Serotype 8 | 639 Titer (1/dilution) |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 2: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Vaccination | Serotype 10A | 1052 Titer (1/dilution) |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 2: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Vaccination | Serotype 11A | 2673 Titer (1/dilution) |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 2: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Vaccination | Serotype 12F | 2416 Titer (1/dilution) |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 2: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Vaccination | Serotype 15B | 586 Titer (1/dilution) |
| Stage 1: Tdap (50 to 64 Years of Age) | Stage 2: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Vaccination | Serotype 22F | 2723 Titer (1/dilution) |