Pneumococcal Infections
Conditions
Keywords
pneumococcal conjugate vaccine, vaccine
Brief summary
To evaluate the safety of 13-valent pneumococcal conjugate vaccine (13vPnC) in elderly subjects who were vaccinated with one or more doses of 23-valent pneumococcal polysaccharide vaccine (23vPS) at least 3 years before study enrollment.
Interventions
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
68 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
MAIN INCLUSION CRITERIA: * Male or female aged 68 years or older * Determined by medical history, physical examination, and clinical judgment to be eligible for the study * Documented vaccination with 1 or more doses of pneumococcal vaccine at least 3 years before study enrollment MAIN
Exclusion criteria
* Known history of severe reaction to a vaccine * Documented S pneumoniae infection within the past 5 years. * Known or suspected immunodeficiency or receiving treatment with immunosuppressive therapy including cytotoxic agents or systemic corticosteroids * Serious chronic disorder including metastatic malignancy, severe chronic obstructive pulmonary disease requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that in the investigator's opinion precludes the subject from participating in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Pre-specified Local Reactions | Days 1 through 14 | Local reactions were collected by the participant using an electronic diary. Redness and swelling scaled as any(present); mild(2.5-5.0 centimeters\[cm\]); moderate(5.1-10.0 cm); severe(\>10.0cm). Pain as any(present); mild(present, no interference with activity); moderate(present, some interference with activity); severe(present, prevents daily activity). Limitation of arm movement as any(present); mild(present, could move arm above head); moderate(could move arm above shoulder but not above head); severe(could not move arm above shoulder). Participants may be represented in more than 1 category. |
| Percentage of Participants With Pre-specified Systemic Events | Days 1 through 14 | Systemic events were collected by participant using electronic diary. Fatigue,headache,new/aggravated generalized muscle pain,new/aggravated generalized joint pain: any, mild(no interference with activity), moderate(some interference with activity), severe(prevents routine daily activity). Fever(\>=38 degrees Celsius\[C\]), chills, rash, vomiting(mild:1-2 times daily; moderate:\>2 times daily; severe:prevents daily activity) decreased appetite & diarrhea(mild:2-3 loose stools/day; moderate:4-5 loose stools/day; severe:\>=6 loose stools/day) reported. Participants may be represented in \>1 category. |
| Percentage of Participants Taking Pain or Antipyretic Medication | Days 1 through 14 | Use of pain or antipyretic medication was collected by the participants using an electronic diary. |
Countries
Germany, Sweden, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 13vPnC Participants received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) into the deltoid muscle of the arm. | 1,049 |
| Total | 1,049 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Assigned, not treated | 4 |
| Overall Study | Death | 3 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | 13vPnC |
|---|---|
| Age Continuous | 75.3 years STANDARD_DEVIATION 5.1 |
| Sex: Female, Male Female | 584 Participants |
| Sex: Female, Male Male | 465 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 486 / 1,049 | 77 / 1,049 |
| serious Total, serious adverse events | 10 / 1,049 | 41 / 1,049 |
Outcome results
Primary
Percentage of Participants Taking Pain or Antipyretic Medication
Use of pain or antipyretic medication was collected by the participants using an electronic diary.
Time frame: Days 1 through 14
Population: Safety population: all participants who received 1 dose of 13vPnC. n = number of participants with the event as yes for at least 1 day or as no for all days.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants Taking Pain or Antipyretic Medication | Use of medication to treat pain (n=677) | 17.0 Percentage of Participants |
| 13vPnC | Percentage of Participants Taking Pain or Antipyretic Medication | Use of medication to treat fever (n=655) | 6.4 Percentage of Participants |
Primary
Percentage of Participants With Pre-specified Local Reactions
Local reactions were collected by the participant using an electronic diary. Redness and swelling scaled as any(present); mild(2.5-5.0 centimeters\[cm\]); moderate(5.1-10.0 cm); severe(\>10.0cm). Pain as any(present); mild(present, no interference with activity); moderate(present, some interference with activity); severe(present, prevents daily activity). Limitation of arm movement as any(present); mild(present, could move arm above head); moderate(could move arm above shoulder but not above head); severe(could not move arm above shoulder). Participants may be represented in more than 1 category.
Time frame: Days 1 through 14
Population: Safety population: all participants who received 1 dose of 13vPnC. n = participants reporting yes for at least 1 day or no for all days.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions | Redness: Any (n=666) | 14.3 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions | Redness: Mild (n=660) | 12.6 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions | Redness: Moderate (n=649) | 6.5 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions | Redness: Severe (n=638) | 1.1 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions | Swelling: Any (n=664) | 12.8 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions | Swelling: Mild (n=658) | 10.9 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions | Swelling: Moderate (n=651) | 5.5 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions | Swelling: Severe (n=636) | 0.6 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions | Pain: Any (n=777) | 51.0 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions | Pain: Mild (n=770) | 49.4 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions | Pain: Moderate (n=656) | 9.0 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions | Pain: Severe (n=634) | 0.2 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions | Limitation of arm movement: Any (n=679) | 16.2 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions | Limitation of arm movement: Mild (n=674) | 14.8 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions | Limitation of arm movement: Moderate (n=636) | 1.6 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions | Limitation of arm movement: Severe (n=640) | 1.6 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions | Any local reaction (n=802) | 56.6 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions | Any severe local reaction (n=643) | 2.6 Percentage of Participants |
Primary
Percentage of Participants With Pre-specified Systemic Events
Systemic events were collected by participant using electronic diary. Fatigue,headache,new/aggravated generalized muscle pain,new/aggravated generalized joint pain: any, mild(no interference with activity), moderate(some interference with activity), severe(prevents routine daily activity). Fever(\>=38 degrees Celsius\[C\]), chills, rash, vomiting(mild:1-2 times daily; moderate:\>2 times daily; severe:prevents daily activity) decreased appetite & diarrhea(mild:2-3 loose stools/day; moderate:4-5 loose stools/day; severe:\>=6 loose stools/day) reported. Participants may be represented in \>1 category.
Time frame: Days 1 through 14
Population: Safety population: all participants who received 1 dose of 13vPnC. n = number of participants with the event as yes for at least 1 day or as no for all days.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events | Headache: Severe (n=637) | 0.8 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events | Fever (any): >=38 degrees C (n=641) | 2.0 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events | Fever: >=38 degrees C but <38.5 degrees C (n=636) | 0.8 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events | Fever: >=38.5 degrees C but <39 degrees C (n=634) | 0.0 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events | Fever: >=39 degrees C but <=40 degrees C (n=635) | 0.3 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events | Fever: >40 degrees C (n=638) | 0.9 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events | Fatigue: Any (n=733) | 34.4 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events | Fatigue: Mild (n=710) | 28.7 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events | Fatigue: Moderate (n=683) | 15.2 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events | Fatigue: Severe (n=639) | 2.0 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events | Headache: Any (n=702) | 26.1 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events | Headache: Mild (n=696) | 24.1 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events | Headache: Moderate (n=655) | 9.0 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events | Chills (n=651) | 7.5 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events | Rash (n=658) | 8.4 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events | Vomiting: Any (vomiting present; n=638) | 0.9 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events | Vomiting: Mild (1 to 2 times in 24 hours;n=637) | 0.8 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events | Vomiting: Moderate (>2 times in 24 hours;n=635) | 0.2 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events | Vomiting: Severe (prevents routine activity;n=634) | 0.0 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events | Decreased appetite (n=668) | 11.2 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events | Diarrhea: Any (diarrhea present; n=684) | 14.5 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events | Diarrhea: Mild (2 to 3 loose stools/day; n=678) | 12.8 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events | Diarrhea: Moderate (4 to 5 loose stools/day;n=644) | 3.4 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events | Diarrhea: Severe (>=6 loose stools/day; n=635) | 0.3 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events | New generalized muscle pain: Any (n=700) | 25.3 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events | New generalized muscle pain: Mild (n=679) | 20.5 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events | New generalized muscle pain: Moderate (n=658) | 7.9 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events | New generalized muscle pain: Severe (n=636) | 0.6 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events | Aggravated generalized muscle pain: Any (n=669) | 12.3 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events | Aggravated generalized muscle pain: Mild (n=650) | 7.5 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events | Aggravated generalized muscle pain:Moderate(n=655) | 6.4 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events | Aggravated generalized muscle pain: Severe (n=639) | 1.4 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events | New generalized joint pain: Any (n=665) | 12.8 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events | New generalized joint pain: Mild (n=651) | 8.1 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events | New generalized joint pain: Moderate (n=648) | 5.7 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events | New generalized joint pain: Severe (n=637) | 0.8 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events | Aggravated generalized joint pain: Any (n=661) | 9.7 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events | Aggravated generalized joint pain: Mild (n=647) | 5.7 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events | Aggravated generalized joint pain: Moderate(n=647) | 5.1 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events | Aggravated generalized joint pain: Severe (n=637) | 1.1 Percentage of Participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events | Any systemic event (n=832) | 58.4 Percentage of Participants |