A Phase 2 interventional study of Multivalent and Prevnar 13 in Pneumococcal Infections, sponsored by Pfizer. Completed at 14 sites in United States. Open to participants aged 60 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-26.
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 35th 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 39th 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: 60 Years to 64 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 444 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 Phase 2, randomized, double-blinded study with a 2-arm parallel design. Healthy adults aged 60 through 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 followed 1 month later with a dose of saline or Prevnar 13 followed 1 month later with a dose of PPSV23 (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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pneumococcal conjugate vaccine
Biological: Multivalent · Other: Saline
Prevnar 13 and PPSV23
Biological: Prevnar 13 · Biological: PPSV23
Pneumococcal conjugate vaccine
Pneumococcal conjugate vaccine
Drug page: 23-valent pneumococcal capsular polysaccharide vaccine
Pneumococcal polysaccharide vaccine
Also known as: Pneumovax 23
Placebo
Percentage of Participants With Local Reactions Within 10 Days After Vaccination 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 centimeter (cm), moderate: 5.5 to 10.0 cm and severe: greater than or equal to (\>=) 10.5 cm. Pain was graded as mild: did not interfere with activity, moderate: interfered with activity and severe: prevented daily activity.
Time frame: within 10 days after Vaccination 1
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
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 mild: no interference with activity, moderate: some interference with activity and severe: prevents daily routine activity.
Time frame: within 7 days after Vaccination 1
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination 1
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.
Time frame: within 1 month after Vaccination 1 (up to 35 days)
Percentage of Participants With Serious Adverse Events (SAEs) or Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination 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. 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 with either SAE or NDCMCs during the specified duration are reported.
Time frame: within 6 months after Vaccination 1 (up to 196 days)
Percentage of Participants With Serious Adverse Events (SAEs) or Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 12 Months After Vaccination 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. 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 with either SAE or NDCMCs during the specified duration are reported.
Time frame: within 12 months after Vaccination 1 (up to 378 days)
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Vaccination 1: 13 Common Serotypes in 13vPnC
Antibody-mediated serum OPA against the 13 common pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) 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.
Time frame: 1 month after Vaccination 1
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Any Vaccination: 7 Additional Serotypes in 20vPnC
Antibody-mediated serum OPA against the 7 additional pneumococcal serotypes (8, 10A, 11A, 12F, 15B, 22F, 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: 1 month after Vaccination 1 for 20vPnC followed by saline reporting group; 1 month after Vaccination 2 for 13vPnC followed by PPSV23 reporting group
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post-Vaccination 1: 13 Common Serotypes in 13vPnC
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before Vaccination 1 to one month after Vaccination 1 were calculated as the mean of the difference of logarithmically transformed OPA results (after vaccination - before vaccination) and transform back to the original scale. GMFRs were calculated using data from participants with non-missing OPA results at both time points. Assay results below the LLOQ were set to 0.5\*LLOQ in the analysis.
Time frame: before Vaccination 1 to one month after Vaccination 1
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post Any Vaccination: 7 Additional Serotypes in 20vPnC
GMFR for 7 additional pneumococcal serotypes (8, 10A, 11A, 12F, 15B, 22F, 33F) from before Vaccination 1 to one month after either Vaccination 1 (20vPnC) or Vaccination 2 (PPSV23) were calculated as the mean of the difference of logarithmically transformed OPA results (after vaccination - before vaccination) and transform back to the original scale. GMFRs were calculated using data from participants with non-missing OPA results at both time points. Assay results below the LLOQ were set to 0.5\*LLOQ in the analysis.
Time frame: before Vaccination 1 to 1 month after Vaccination 1 for 20vPnC followed by saline reporting group; before Vaccination 1 to 1 month after Vaccination 2 for 13vPnC followed by PPSV23 reporting group
| Milestone | 20vPnC Followed by Saline | 13vPnC Followed by PPSV23 |
|---|---|---|
| Started | 222 | 222 |
| Safety population | 221 | 222 |
| Evaluable immunogenicity population(eip) | 210 | 208 |
| Completed | 202 | 202 |
| Not completed | 20 | 20 |
| Withdrew: Protocol violation | 4 | 1 |
| Withdrew: Other | 1 | 1 |
| Withdrew: Withdrawal by subject | 4 | 3 |
| Withdrew: No longer meets eligibility criteria | 1 | 7 |
| Withdrew: Lost to follow-up | 9 | 8 |
| Withdrew: Randomized but not treated | 1 | 0 |
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 centimeter (cm), moderate: 5.5 to 10.0 cm and severe: greater than or equal to (\>=) 10.5 cm. Pain was graded as mild: did not interfere with activity, moderate: interfered with activity and severe: prevented daily activity.
| percentage of participants | 20vPnC Followed by Saline | 13vPnC Followed by PPSV23 |
|---|---|---|
| Redness: Mild | 7.3 (4.2 to 11.5) | 3.6 (1.6 to 7.0) |
| Redness: Moderate | 3.6 (1.6 to 7.0) | 3.2 (1.3 to 6.4) |
| Redness: Severe | 0.5 (0.0 to 2.5) | 0 (0.0 to 1.6) |
| Swelling: Mild | 7.7 (4.6 to 12.1) | 7.7 (4.5 to 12.0) |
| Swelling: Moderate | 5.5 (2.8 to 9.3) | 3.6 (1.6 to 7.0) |
| Swelling: Severe | 0 (0.0 to 1.7) | 0 (0.0 to 1.6) |
| Pain at injection site: Mild | 46.8 (40.1 to 53.6) | 43.7 (37.1 to 50.5) |
| Pain at injection site: Moderate | 10.9 (7.1 to 15.8) | 9.5 (6.0 to 14.1) |
| Pain at injection site: Severe | 0 (0.0 to 1.7) | 0.5 (0.0 to 2.5) |
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 mild: no interference with activity, moderate: some interference with activity and severe: prevents daily routine activity.
| percentage of participants | 20vPnC Followed by Saline | 13vPnC Followed by PPSV23 |
|---|---|---|
| Fever: >=38.0 degree C | 0 (0.0 to 1.7) | 0.5 (0.0 to 2.5) |
| Fever: >=38.0 to 38.4 degree C | 0 (0.0 to 1.7) | 0.5 (0.0 to 2.5) |
| Fever: >38.4 to 38.9 degree C | 0 (0.0 to 1.7) | 0 (0.0 to 1.6) |
| Fever: >38.9 to 40.0 degree C | 0 (0.0 to 1.7) | 0 (0.0 to 1.6) |
| Fever: >40.0 degree C | 0 (0.0 to 1.7) | 0 (0.0 to 1.6) |
| Fatigue: Mild | 19.1 (14.1 to 24.9) | 18.0 (13.2 to 23.7) |
| Fatigue: Moderate | 11.4 (7.5 to 16.3) | 10.4 (6.7 to 15.1) |
| Fatigue: Severe | 0.5 (0.0 to 2.5) | 1.8 (0.5 to 4.5) |
| Headache: Mild | 16.8 (12.1 to 22.4) | 18.0 (13.2 to 23.7) |
| Headache: Moderate | 3.6 (1.6 to 7.0) | 5.4 (2.8 to 9.3) |
| Headache: Severe | 0.5 (0.0 to 2.5) | 0.9 (0.1 to 3.2) |
| Muscle pain: Mild | 32.7 (26.6 to 39.4) | 27.0 (21.3 to 33.4) |
| Muscle pain: Moderate | 10.5 (6.7 to 15.3) | 9.5 (6.0 to 14.1) |
| Muscle pain: Severe | 0 (0.0 to 1.7) | 0 (0.0 to 1.6) |
| Joint pain: Mild | 9.5 (6.0 to 14.2) | 8.1 (4.9 to 12.5) |
| Joint pain: Moderate | 5.5 (2.8 to 9.3) | 5.9 (3.2 to 9.8) |
| Joint pain: Severe | 0 (0.0 to 1.7) | 0.5 (0.0 to 2.5) |
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.
| percentage of participants | 20vPnC Followed by Saline | 13vPnC Followed by PPSV23 |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination 1 | 12.2 (8.2 to 17.3) | 13.1 (8.9 to 18.2) |
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. 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 with either SAE or NDCMCs during the specified duration are reported.
| percentage of participants | 20vPnC Followed by Saline | 13vPnC Followed by PPSV23 |
|---|---|---|
| Percentage of Participants With Serious Adverse Events (SAEs) or Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination 1 | 5.4 (2.8 to 9.3) | 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. 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 with either SAE or NDCMCs during the specified duration are reported.
| percentage of participants | 20vPnC Followed by Saline | 13vPnC Followed by PPSV23 |
|---|---|---|
| Percentage of Participants With Serious Adverse Events (SAEs) or Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 12 Months After Vaccination 1 | 10.0 (6.3 to 14.7) | 6.3 (3.5 to 10.4) |
Antibody-mediated serum OPA against the 13 common pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) 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.
| Titer (1/dilution) | 20vPnC Followed by Saline | 13vPnC Followed by PPSV23 |
|---|---|---|
| Serotype 1 | 302 (239.6 to 381.4) | 454 (352.6 to 584.5) |
| Serotype 3 | 51 (43.2 to 61.2) | 64 (54.1 to 76.7) |
| Serotype 4 | 876 (676.8 to 1134.7) | 1153 (883.3 to 1504.1) |
| Serotype 5 | 144 (113.3 to 183.2) | 215 (168.7 to 274.4) |
| Serotype 6A | 1907 (1492.7 to 2436.2) | 2440 (1848.9 to 3219.9) |
| Serotype 6B | 2006 (1591.4 to 2527.5) | 2218 (1716.9 to 2865.1) |
| Serotype 7F | 1581 (1361.6 to 1836.0) | 1936 (1651.1 to 2269.6) |
| Serotype 9V | 1164 (949.6 to 1428.0) | 1612 (1311.4 to 1981.4) |
| Serotype 14 | 1114 (905.0 to 1371.4) | 1282 (1017.4 to 1614.9) |
| Serotype 18C | 1322 (1053.2 to 1658.9) | 1660 (1335.1 to 2064.5) |
| Serotype 19A | 943 (783.5 to 1136.1) | 1137 (936.5 to 1379.4) |
| Serotype 19F | 455 (349.2 to 592.2) | 738 (582.1 to 936.5) |
| Serotype 23F | 408 (293.0 to 568.0) | 509 (377.3 to 687.1) |
Antibody-mediated serum OPA against the 7 additional pneumococcal serotypes (8, 10A, 11A, 12F, 15B, 22F, 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) | 20vPnC Followed by Saline | 13vPnC Followed by PPSV23 |
|---|---|---|
| Serotype 8 | 740 (598.0 to 915.7) | 1150 (944.4 to 1401.6) |
| Serotype 10A | 2604 (2096.4 to 3234.4) | 988 (731.2 to 1335.5) |
| Serotype 11A | 3210 (2613.2 to 3943.8) | 3007 (2443.0 to 3700.3) |
| Serotype 12F | 6571 (5022.2 to 8597.3) | 4290 (3190.8 to 5769.1) |
| Serotype 15B | 1889 (1434.7 to 2488.3) | 720 (530.8 to 975.9) |
| Serotype 22F | 6286 (5025.0 to 7863.2) | 3513 (2824.8 to 4367.7) |
| Serotype 33F | 5584 (4374.1 to 7128.0) | 3940 (3136.2 to 4950.9) |
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before Vaccination 1 to one month after Vaccination 1 were calculated as the mean of the difference of logarithmically transformed OPA results (after vaccination - before vaccination) and transform back to the original scale. GMFRs were calculated using data from participants with non-missing OPA results at both time points. Assay results below the LLOQ were set to 0.5\*LLOQ in the analysis.
| fold rise | 20vPnC Followed by Saline | 13vPnC Followed by PPSV23 |
|---|---|---|
| Serotype 1 | 21.2 (16.96 to 26.60) | 33.5 (25.77 to 43.65) |
| Serotype 3 | 6.0 (5.02 to 7.23) | 7.1 (5.85 to 8.60) |
| Serotype 4 | 37.8 (27.40 to 52.10) | 51.0 (36.04 to 72.27) |
| Serotype 5 | 8.3 (6.55 to 10.54) | 11.6 (9.09 to 14.86) |
| Serotype 6A | 58.6 (44.15 to 77.73) | 68.6 (49.49 to 95.20) |
| Serotype 6B | 29.6 (22.56 to 38.96) | 38.8 (28.52 to 52.66) |
| Serotype 7F | 12.2 (9.86 to 15.22) | 15.8 (12.57 to 19.82) |
| Serotype 9V | 7.7 (6.15 to 9.57) | 10.1 (7.95 to 12.74) |
| Serotype 14 | 8.5 (6.35 to 11.26) | 9.6 (7.20 to 12.89) |
| Serotype 18C | 26.8 (19.96 to 35.85) | 35.2 (26.02 to 47.50) |
| Serotype 19A | 23.3 (17.96 to 30.19) | 30.9 (23.70 to 40.37) |
| Serotype 19F | 11.8 (8.93 to 15.47) | 18.4 (14.19 to 23.87) |
| Serotype 23F | 33.6 (24.19 to 46.54) | 39.8 (28.85 to 54.88) |
GMFR for 7 additional pneumococcal serotypes (8, 10A, 11A, 12F, 15B, 22F, 33F) from before Vaccination 1 to one month after either Vaccination 1 (20vPnC) or Vaccination 2 (PPSV23) were calculated as the mean of the difference of logarithmically transformed OPA results (after vaccination - before vaccination) and transform back to the original scale. GMFRs were calculated using data from participants with non-missing OPA results at both time points. Assay results below the LLOQ were set to 0.5\*LLOQ in the analysis.
| fold rise | 20vPnC Followed by Saline | 13vPnC Followed by PPSV23 |
|---|---|---|
| Serotype 8 | 37.1 (27.71 to 49.71) | 56.9 (42.90 to 75.46) |
| Serotype 10A | 49.3 (35.18 to 68.95) | 17.1 (12.15 to 24.15) |
| Serotype 11A | 11.2 (8.16 to 15.31) | 9.8 (7.41 to 13.06) |
| Serotype 12F | 113.4 (81.47 to 157.90) | 77.0 (55.04 to 107.64) |
| Serotype 15B | 57.1 (41.74 to 78.07) | 21.3 (15.30 to 29.71) |
| Serotype 22F | 55.4 (38.88 to 79.01) | 20.3 (14.69 to 27.96) |
| Serotype 33F | 14.0 (9.96 to 19.62) | 8.9 (6.67 to 11.84) |
Collected over Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 20vPnC Followed by Saline | 0/221 (0%) | 9/221 (4.1%) | 162/221 (73.3%) |
| 13vPnC Followed by PPSV23 | 0/222 (0%) | 11/222 (5%) | 164/222 (73.9%) |
| Event | 20vPnC Followed by Saline | 13vPnC Followed by PPSV23 |
|---|---|---|
| Cerebrovascular accidentNervous system disorders | 0/221 | 2/222 |
| Chest painGeneral disorders | 1/221 | 0/222 |
| Cellulitis staphylococcalInfections and infestations | 1/221 | 0/222 |
| Septic shockInfections and infestations | 1/221 | 0/222 |
| AdenocarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/221 | 0/222 |
| Lung neoplasm malignantNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/221 | 0/222 |
| Spindle cell sarcomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/221 | 0/222 |
| Uterine cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/221 | 0/222 |
| Lacunar infarctionNervous system disorders | 1/221 | 0/222 |
| SeizureNervous system disorders | 1/221 | 0/222 |
| Event | 20vPnC Followed by Saline | 13vPnC Followed by PPSV23 |
|---|---|---|
| Injection site painGeneral disorders | 127/221 | 119/222 |
| MyalgiaMusculoskeletal and connective tissue disorders | 95/221 | 81/222 |
| FatigueGeneral disorders | 68/221 | 67/222 |
| HeadacheNervous system disorders | 46/221 | 54/222 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 33/221 | 32/222 |
| SwellingGeneral disorders | 29/221 | 25/222 |
| ErythemaGeneral disorders | 25/221 | 15/222 |
| Upper respiratory tract infectionInfections and infestations | 7/221 | 5/222 |
| SinusitisInfections and infestations | 3/221 | 0/222 |
| BronchitisInfections and infestations | 2/221 | 0/222 |
Safety analysis set included all participants who had received 1 dose of 20vPnC or 13vPnC.
| Age, Continuous(years) | 20vPnC Followed by Saline | 13vPnC Followed by PPSV23 | Total |
|---|---|---|---|
| Mean | 62.0 ± 1.40 | 62.0 ± 1.41 | 62.0 ± 1.41 |
| Sex: Female, Male(Participants) | 20vPnC Followed by Saline | 13vPnC Followed by PPSV23 | Total |
|---|---|---|---|
| Female | 115 | 133 | 248 |
| Male | 106 | 89 | 195 |
| Ethnicity (NIH/OMB)(Participants) | 20vPnC Followed by Saline | 13vPnC Followed by PPSV23 | Total |
|---|---|---|---|
| Hispanic or Latino | 27 | 25 | 52 |
| Not Hispanic or Latino | 192 | 195 | 387 |
| Unknown or Not Reported | 2 | 2 | 4 |
| Race (NIH/OMB)(Participants) | 20vPnC Followed by Saline | 13vPnC Followed by PPSV23 | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 2 | 3 |
| Asian | 8 | 7 | 15 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 37 | 46 | 83 |
| White | 169 | 165 | 334 |
| More than one race | 4 | 2 | 6 |
| Unknown or Not Reported | 1 | 0 | 1 |
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 Dec 2018, 14 months.
Results were first posted in Dec 2019, 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 14 months is below that.
How these figures are worked out, and which studies are left out of them.
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