A Phase 2 interventional study of Multivalent and Tdap in Pneumococcal Infections, sponsored by Pfizer. Completed at 18 sites in United States. Open to participants aged 50 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-04.
Sponsored by Pfizer · Phase 2, Interventional, and Prevention
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Among 75 studies in Pneumococcal Infections by Pfizer — 4 open to participants now, 8 under way, 5 of them phase 3. Pneumococcal Infections · Pfizer.
Among the 75 studies in Pneumococcal Infections by Pfizer, this one is the 32nd largest by enrollment of the 57 interventional ones that give a count, is one of 3 that started in 2017, is one of 7 in phase 2, and was the 40th registered.
298 studies on the registry are indexed under Pneumococcal Infections; 25 are open to participants now.
Browse Pneumococcal Infections studies →4 of the 75 studies in Pneumococcal Infections by Pfizer are open now, in 12 countries. Recruiting first, the newest first:
Pfizer · Sites in China
Ages 42 days–98 days · Healthy volunteers
Pfizer · Sites in United States, Finland, Poland and 1 more country
Ages 15 mo–17 yrs · Healthy volunteers
Pfizer · Sites in United States, Japan, Puerto Rico
Ages 42 days–211 days · Healthy volunteers
Pfizer · Sites in United States, Argentina, Australia and 8 more countries
Ages 42 days–98 days · Healthy volunteers
By country, each count listing its studies:
Of the 20 Pneumococcal Infections studies recruiting now, 4 (20%) set no upper age limit and 14 (70%) stop at 75 or younger; 14 take children under 18; 16 take healthy volunteers.
This study: 50 Years to 85 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
75 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 10 · Phase 2 9 · Phase 3 33 · Phase 4 7
First in 2001; this study’s year is marked. 3 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 511 is above the median of 373 across 253 interventional studies indexed under Pneumococcal Infections.
Median enrollment 570 across the 57 interventional studies, 1,050 across the 18 observational. Of the 67 that completed or were terminated, 45 (67%) have results posted.
This tab as a report to print or save as PDF → With an account.
Pfizer is the lead sponsor of 3,337 studies on the registry; 150 are open to participants now.
Of its 601 completed or terminated interventional studies of FDA-regulated products, 392 (65%) have results posted.
4 of the studies in Pneumococcal Infections by Pfizer that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07794748Phase 3PfizerA Study to Assess the Safety, Tolerability, and Immunogenicity of 3 Lots of a Multivalent Pneumococcal Conjugate Vaccine Administered to Adults | 2027-04-26 |
| NCT06622109PfizerA Study to Learn About the Safety of PREVENAR 20 Vaccine in Infants Aged Between Two to Six Months | 2026-12-04 |
| NCT06524414PfizerA Study to Learn About How a New Pneumococcal Vaccine Works in Infants | 2027-03-04 |
| NCT07023081PfizerA Study to Understand the Safety of the 20vPnC Vaccine in Healthy Chinese Adults, Children, and Infant | 2027-06-10 |
Add all 4 to your calendar (.ics) → With an account.
Among the 75 studies in Pneumococcal Infections by Pfizer, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
multivalent
Biological: Multivalent
Tdap
Biological: Tdap
multivalent
Biological: Multivalent
polysaccharide
Biological: polysaccharide
Pneumococcal conjugate vaccine
Tetanus, diphtheria, acellular pertussis vaccine
23-valent pneumococcal polysaccharide vaccine
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
| Milestone | 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) |
|---|---|---|---|---|
| Started | 34 | 32 | 0 | 0 |
| Vaccinated | 34 | 32 | 0 | 0 |
| Completed | 34 | 32 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 |
| Milestone | 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) |
|---|---|---|---|---|
| Started | 0 | 0 | 221 | 224 |
| Vaccinated | 0 | 0 | 221 | 223 |
| Completed | 0 | 0 | 210 | 204 |
| Not completed | 0 | 0 | 11 | 20 |
| Withdrew: Adverse event | 0 | 0 | 0 | 1 |
| Withdrew: Death | 0 | 0 | 3 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 1 | 5 |
| Withdrew: No longer meets eligibility criteria | 0 | 0 | 0 | 3 |
| Withdrew: Protocol deviation | 0 | 0 | 7 | 7 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 3 |
| Withdrew: Other | 0 | 0 | 0 | 1 |
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.
| percentage of participants | Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Tdap (50 to 64 Years of Age) |
|---|---|---|
| Redness: Any | 2.9 (0.1 to 15.3) | 12.5 (3.5 to 29.0) |
| Redness: Mild | 2.9 (0.1 to 15.3) | 6.3 (0.8 to 20.8) |
| Redness: Moderate | 0 (0.0 to 10.3) | 6.3 (0.8 to 20.8) |
| Redness: Severe | 0 (0.0 to 10.3) | 0 (0.0 to 10.9) |
| Swelling: Any | 8.8 (1.9 to 23.7) | 18.8 (7.2 to 36.4) |
| Swelling: Mild | 5.9 (0.7 to 19.7) | 6.3 (0.8 to 20.8) |
| Swelling: Moderate | 2.9 (0.1 to 15.3) | 12.5 (3.5 to 29.0) |
| Swelling: Severe | 0 (0.0 to 10.3) | 0 (0.0 to 10.9) |
| Pain at injection site: Any | 64.7 (46.5 to 80.3) | 71.9 (53.3 to 86.3) |
| Pain at injection site: Mild | 50.0 (32.4 to 67.6) | 59.4 (40.6 to 76.3) |
| Pain at injection site: Moderate | 14.7 (5.0 to 31.1) | 12.5 (3.5 to 29.0) |
| Pain at injection site: Severe | 0 (0.0 to 10.3) | 0 (0.0 to 10.9) |
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.
| percentage of participants | Stage 2: c7vPnC (65 to 85 Years of Age) | Stage 2: PPSV23 (65 to 85 Years of Age) |
|---|---|---|
| Redness: Any | 8.1 (4.9 to 12.6) | 17.9 (13.1 to 23.6) |
| Redness: Mild | 5.9 (3.2 to 9.8) | 8.1 (4.9 to 12.5) |
| Redness: Moderate | 2.3 (0.7 to 5.2) | 4.5 (2.2 to 8.1) |
| Redness: Severe | 0 (0.0 to 1.7) | 5.4 (2.8 to 9.2) |
| Swelling: Any | 6.8 (3.8 to 10.9) | 16.6 (12.0 to 22.1) |
| Swelling: Mild | 5.9 (3.2 to 9.8) | 5.4 (2.8 to 9.2) |
| Swelling: Moderate | 0.9 (0.1 to 3.2) | 7.6 (4.5 to 11.9) |
| Swelling: Severe | 0 (0.0 to 1.7) | 3.6 (1.6 to 6.9) |
| Pain at injection site: Any | 48.4 (41.7 to 55.2) | 61.0 (54.2 to 67.4) |
| Pain at injection site: Mild | 46.6 (39.9 to 53.4) | 44.8 (38.2 to 51.6) |
| Pain at injection site: Moderate | 1.8 (0.5 to 4.6) | 14.3 (10.0 to 19.6) |
| Pain at injection site: Severe | 0 (0.0 to 1.7) | 1.8 (0.5 to 4.5) |
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.
| percentage of participants | Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Tdap (50 to 64 Years of Age) |
|---|---|---|
| Fever: >=38.0 degree C | 0 (0.0 to 10.3) | 0 (0.0 to 10.9) |
| Fever: >=38.0 to 38.4 degree C | 0 (0.0 to 10.3) | 0 (0.0 to 10.9) |
| Fever: >38.4 to 38.9 degree C | 0 (0.0 to 10.3) | 0 (0.0 to 10.9) |
| Fever: >38.9 to 40.0 degree C | 0 (0.0 to 10.3) | 0 (0.0 to 10.9) |
| Fever: >40.0 degree C | 0 (0.0 to 10.3) | 0 (0.0 to 10.9) |
| Fatigue: Any | 29.4 (15.1 to 47.5) | 28.1 (13.7 to 46.7) |
| Fatigue: Mild | 29.4 (15.1 to 47.5) | 9.4 (2.0 to 25.0) |
| Fatigue: Moderate | 0 (0.0 to 10.3) | 18.8 (7.2 to 36.4) |
| Fatigue: Severe | 0 (0.0 to 10.3) | 0 (0.0 to 10.9) |
| Headache: Any | 38.2 (22.2 to 56.4) | 34.4 (18.6 to 53.2) |
| Headache: Mild | 23.5 (10.7 to 41.2) | 18.8 (7.2 to 36.4) |
| Headache: Moderate | 14.7 (5.0 to 31.1) | 15.6 (5.3 to 32.8) |
| Headache: Severe | 0 (0.0 to 10.3) | 0 (0.0 to 10.9) |
| Muscle pain: Any | 38.2 (22.2 to 56.4) | 56.3 (37.7 to 73.6) |
| Muscle pain: Mild | 26.5 (12.9 to 44.4) | 43.8 (26.4 to 62.3) |
| Muscle pain: Moderate | 11.8 (3.3 to 27.5) | 12.5 (3.5 to 29.0) |
| Muscle pain: Severe | 0 (0.0 to 10.3) | 0 (0.0 to 10.9) |
| Joint pain: Any | 11.8 (3.3 to 27.5) | 15.6 (5.3 to 32.8) |
| Joint pain: Mild | 11.8 (3.3 to 27.5) | 12.5 (3.5 to 29.0) |
| Joint pain: Moderate | 0 (0.0 to 10.3) | 3.1 (0.1 to 16.2) |
| Joint pain: Severe | 0 (0.0 to 10.3) | 0 (0.0 to 10.9) |
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.
| percentage of participants | Stage 2: c7vPnC (65 to 85 Years of Age) | Stage 2: PPSV23 (65 to 85 Years of Age) |
|---|---|---|
| Fever: >=38.0 degree C | 0.5 (0.0 to 2.5) | 0.9 (0.1 to 3.2) |
| Fever: >=38.0 to 38.4 degree C | 0.5 (0.0 to 2.5) | 0 (0.0 to 1.6) |
| Fever: >38.4 to 38.9 degree C | 0 (0.0 to 1.7) | 0.4 (0.0 to 2.5) |
| Fever: >38.9 to 40.0 degree C | 0 (0.0 to 1.7) | 0.4 (0.0 to 2.5) |
| Fever: >40.0 degree C | 0 (0.0 to 1.7) | 0 (0.0 to 1.6) |
| Fatigue: Any | 34.4 (28.1 to 41.1) | 33.2 (27.0 to 39.8) |
| Fatigue: Mild | 24.9 (19.3 to 31.1) | 17.5 (12.7 to 23.1) |
| Fatigue: Moderate | 7.7 (4.5 to 12.0) | 13.9 (9.6 to 19.1) |
| Fatigue: Severe | 1.8 (0.5 to 4.6) | 1.8 (0.5 to 4.5) |
| Headache: Any | 24.4 (18.9 to 30.6) | 20.2 (15.1 to 26.1) |
| Headache: Mild | 20.4 (15.3 to 26.3) | 14.3 (10.0 to 19.6) |
| Headache: Moderate | 3.6 (1.6 to 7.0) | 5.4 (2.8 to 9.2) |
| Headache: Severe | 0.5 (0.0 to 2.5) | 0.4 (0.0 to 2.5) |
| Muscle pain: Any | 38.5 (32.0 to 45.2) | 46.6 (39.9 to 53.4) |
| Muscle pain: Mild | 31.7 (25.6 to 38.2) | 29.1 (23.3 to 35.6) |
| Muscle pain: Moderate | 6.3 (3.5 to 10.4) | 16.6 (12.0 to 22.1) |
| Muscle pain: Severe | 0.5 (0.0 to 2.5) | 0.9 (0.1 to 3.2) |
| Joint pain: Any | 14.9 (10.5 to 20.3) | 19.7 (14.7 to 25.6) |
| Joint pain: Mild | 9.5 (6.0 to 14.2) | 12.6 (8.5 to 17.6) |
| Joint pain: Moderate | 5.4 (2.8 to 9.3) | 7.2 (4.2 to 11.4) |
| Joint pain: Severe | 0 (0.0 to 1.7) | 0 (0.0 to 1.6) |
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.
| percentage of participants | Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Tdap (50 to 64 Years of Age) |
|---|---|---|
| Stage 1: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination | 8.8 (1.9 to 23.7) | 9.4 (2.0 to 25.0) |
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.
| percentage of participants | Stage 2: c7vPnC (65 to 85 Years of Age) | Stage 2: PPSV23 (65 to 85 Years of Age) |
|---|---|---|
| Stage 2: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination | 10.0 (6.3 to 14.7) | 13.5 (9.3 to 18.6) |
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.
| percentage of participants | Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Tdap (50 to 64 Years of Age) |
|---|---|---|
| Stage 1: Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination | 5.9 (0.7 to 19.7) | 0 (0.0 to 10.9) |
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.
| percentage of participants | Stage 2: c7vPnC (65 to 85 Years of Age) | Stage 2: PPSV23 (65 to 85 Years of Age) |
|---|---|---|
| Stage 2: Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination | 2.3 (0.7 to 5.2) | 2.7 (1.0 to 5.8) |
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.
| percentage of participants | Stage 1: c7vPnC (50 to 64 Years of Age) | 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 | 0 (0.0 to 10.3) | 6.3 (0.8 to 20.8) |
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.
| percentage of participants | Stage 2: c7vPnC (65 to 85 Years of Age) | Stage 2: PPSV23 (65 to 85 Years of Age) |
|---|---|---|
| Stage 2: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination | 3.2 (1.3 to 6.4) | 4.5 (2.2 to 8.1) |
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.
| percentage of participants | Stage 2: c7vPnC (65 to 85 Years of Age) | Stage 2: PPSV23 (65 to 85 Years of Age) |
|---|---|---|
| Stage 2: Percentage of Participants With Serious Adverse Events (SAEs) Within 12 Months After Vaccination | 4.1 (1.9 to 7.6) | 3.6 (1.6 to 6.9) |
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.
| percentage of participants | Stage 2: c7vPnC (65 to 85 Years of Age) | Stage 2: PPSV23 (65 to 85 Years of Age) |
|---|---|---|
| Stage 2: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 12 Months After Vaccination | 6.8 (3.8 to 10.9) | 6.3 (3.5 to 10.3) |
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.
| Titer (1/dilution) | Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Tdap (50 to 64 Years of Age) |
|---|---|---|
| Serotype 8 | 1401 (913.4 to 2147.9) | 16 (9.3 to 26.4) |
| Serotype 10A | 6622 (3705.5 to 11833.0) | 92 (35.3 to 239.3) |
| Serotype 11A | 3154 (1890.7 to 5262.8) | 604 (302.2 to 1206.4) |
| Serotype 12F | 9558 (4114.7 to 22202.0) | 90 (39.6 to 202.8) |
| Serotype 15B | 3926 (1526.1 to 10100.2) | 30 (17.9 to 49.7) |
| Serotype 22F | 5932 (3625.8 to 9705.6) | 167 (74.4 to 374.3) |
| Serotype 33F | 8432 (4116.7 to 17271.3) | 433 (204.7 to 915.4) |
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.
| Titer (1/dilution) | Stage 2: c7vPnC (65 to 85 Years of Age) | Stage 2: PPSV23 (65 to 85 Years of Age) |
|---|---|---|
| Serotype 8 | 528 (423.2 to 658.6) | 639 (511.9 to 798.3) |
| Serotype 10A | 2297 (1842.9 to 2863.4) | 1052 (802.5 to 1378.9) |
| Serotype 11A | 2290 (1854.0 to 2828.7) | 2673 (2182.7 to 3274.6) |
| Serotype 12F | 3684 (2926.5 to 4638.6) | 2416 (1852.8 to 3151.0) |
| Serotype 15B | 1381 (1019.2 to 1872.2) | 586 (426.0 to 807.2) |
| Serotype 22F | 4775 (3889.1 to 5862.2) | 2723 (2123.9 to 3491.1) |
| Serotype 33F | 4250 (3403.2 to 5307.2) | 4043 (3082.4 to 5304.3) |
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.
| fold rise | Stage 1: c7vPnC (50 to 64 Years of Age) | Stage 1: Tdap (50 to 64 Years of Age) |
|---|---|---|
| Serotype 8 | 106.2 (56.7 to 198.9) | 1.1 (1.0 to 1.3) |
| Serotype 10A | 64.7 (28.5 to 146.9) | 1.2 (0.8 to 1.7) |
| Serotype 11A | 6.5 (3.0 to 14.2) | 1.0 (0.7 to 1.5) |
| Serotype 12F | 261.8 (106.1 to 646.2) | 1.2 (1.0 to 1.4) |
| Serotype 15B | 100.2 (32.1 to 312.7) | 1.1 (0.9 to 1.3) |
| Serotype 22F | 58.6 (25.0 to 137.3) | 1.4 (1.1 to 1.8) |
| Serotype 33F | 27.9 (10.4 to 74.6) | 0.9 (0.6 to 1.5) |
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.
| fold rise | Stage 2: c7vPnC (65 to 85 Years of Age) | Stage 2: PPSV23 (65 to 85 Years of Age) |
|---|---|---|
| Serotype 8 | 30.2 (23.0 to 39.6) | 40.5 (30.4 to 53.8) |
| Serotype 10A | 30.6 (21.3 to 43.8) | 15.2 (11.0 to 20.9) |
| Serotype 11A | 7.5 (5.6 to 10.1) | 7.0 (5.2 to 9.4) |
| Serotype 12F | 64.0 (47.3 to 86.8) | 37.6 (27.2 to 52.0) |
| Serotype 15B | 31.7 (22.6 to 44.4) | 16.4 (11.6 to 23.0) |
| Serotype 22F | 30.0 (21.1 to 42.7) | 18.6 (13.4 to 25.9) |
| Serotype 33F | 10.0 (7.0 to 14.2) | 8.7 (6.3 to 11.9) |
Collected over Local reactions and systemic events: within 14 days after vaccination; Non serious AEs: Stage 1 and 2- baseline up to 1 month after vaccination (approximately up to 35 days); SAEs: Stage 1- baseline up to 6 months after vaccination (approximately up to 196 days), Stage 2- baseline up to 12 months after vaccination (approximately up to 378 days). Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Stage 1: c7vPnC (50 to 64 Years of Age) | 0/34 (0%) | 2/34 (5.9%) | 27/34 (79.4%) |
| Stage 1: Tdap (50 to 64 Years of Age) | 0/32 (0%) | 0/32 (0%) | 28/32 (87.5%) |
| Stage 2: c7vPnC (65 to 85 Years of Age) | 3/221 (1.4%) | 9/221 (4.1%) | 161/221 (72.9%) |
| Stage 2: PPSV23 (65 to 85 Years of Age) | 0/223 (0%) | 8/223 (3.6%) | 171/223 (76.7%) |
| Event | 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) |
|---|---|---|---|---|
| Intestinal obstructionGastrointestinal disorders | 1/34 | 0/32 | 0/221 | 0/223 |
| CholecystitisHepatobiliary disorders | 1/34 | 0/32 | 0/221 | 0/223 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 0/34 | 0/32 | 2/221 | 0/223 |
| Aortic valve stenosisCardiac disorders | 0/34 | 0/32 | 1/221 | 0/223 |
| Coronary artery diseaseCardiac disorders | 0/34 | 0/32 | 1/221 | 0/223 |
| Myocardial infarctionCardiac disorders | 0/34 | 0/32 | 1/221 | 0/223 |
| Small intestinal obstructionGastrointestinal disorders | 0/34 | 0/32 | 1/221 | 0/223 |
| Oedema peripheralGeneral disorders | 0/34 | 0/32 | 1/221 | 0/223 |
| Acute myeloid leukaemiaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/34 | 0/32 | 1/221 | 0/223 |
| Lung neoplasm malignantNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/34 | 0/32 | 1/221 | 0/223 |
| Event | 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) |
|---|---|---|---|---|
| Injection site painGeneral disorders | 22/34 | 23/32 | 107/221 | 136/223 |
| MyalgiaMusculoskeletal and connective tissue disorders | 13/34 | 18/32 | 85/221 | 104/223 |
| HeadacheNervous system disorders | 13/34 | 11/32 | 54/221 | 45/223 |
| FatigueGeneral disorders | 10/34 | 9/32 | 76/221 | 74/223 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 4/34 | 5/32 | 33/221 | 44/223 |
| Injection site swellingGeneral disorders | 3/34 | 6/32 | 15/221 | 37/223 |
| Injection site erythemaGeneral disorders | 1/34 | 4/32 | 18/221 | 40/223 |
| NasopharyngitisInfections and infestations | 1/34 | 2/32 | 2/221 | 2/223 |
| GastroenteritisInfections and infestations | 0/34 | 1/32 | 1/221 | 1/223 |
| CystitisInfections and infestations | 1/34 | 0/32 | 0/221 | 0/223 |
The safety population included all participants who received at least 1 dose of c7vPnC or Tdap or PPSV23 in the study and had post-vaccination follow-up and participants who lacked any safety data were excluded from the analysis.
| Age, Continuous(Years) | 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 |
|---|---|---|---|---|---|
| Mean | 58.2 ± 4.52 | 58.1 ± 4.46 | 68.9 ± 4.72 | 68.8 ± 3.97 | 67.5 ± 5.66 |
| Sex: Female, Male(Participants) | 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 |
|---|---|---|---|---|---|
| Female | 23 | 21 | 131 | 135 | 310 |
| Male | 11 | 11 | 90 | 88 | 200 |
| Ethnicity (NIH/OMB)(Participants) | 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 |
|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 2 | 4 | 10 | 16 |
| Not Hispanic or Latino | 34 | 30 | 216 | 213 | 493 |
| Unknown or Not Reported | 0 | 0 | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | 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 |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 6 | 4 | 10 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 11 | 9 | 21 |
| White | 34 | 31 | 204 | 210 | 479 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Data sharing details ↗ · www.pfizer.com
Ran from Oct 2017 to primary completion in May 2019, 19 months.
Results were first posted in Jun 2020, 1 year after primary completion.
Of 23 phase 2 interventional studies under Pneumococcal Infections, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 28. This study's 19 months is close to that.
How these figures are worked out, and which studies are left out of them.
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