A Phase 3 interventional study of Experimental 20-valent pneumococcal conjugate vaccine (20vPnC) and Saline in Pneumococcal Disease, sponsored by Pfizer. Completed at 63 sites in United States. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-08.
Sponsored by Pfizer · Phase 3, Interventional, and Prevention
Study of the safety and immunogenicity of 20vPnC and influenza vaccine administered at the same visit or separately
281 studies on the registry are indexed under Pneumococcal Infections; 27 are open to participants now.
This study's enrollment of 1,796 is above the median of 379 across 230 interventional studies indexed under Pneumococcal Infections.
Browse Pneumococcal Infections studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Vaccination with any influenza or pneumococcal vaccine \<6 months before investigational product administration, or planned receipt of any licensed or investigational non-study influenza vaccine during study participation.
-- Serious chronic disorder, that in the investigator's opinion would make the participant inappropriate for entry into the study
Participants receive injections of pneumococcal vaccine (20vPnC) and influenza vaccine at the same visit, and then receive an injection of saline 1 month later.
Biological: Experimental 20-valent pneumococcal conjugate vaccine (20vPnC) · Other: Saline · Biological: Influenza vaccine
Participants receive injections of saline and influenza vaccine at the same visit, and then receive an injection of 20vPnC 1 month later.
Biological: Experimental 20-valent pneumococcal conjugate vaccine (20vPnC) · Other: Saline · Biological: Influenza vaccine
Experimental 20-valent pneumococcal conjugate vaccine (20vPnC)
Normal saline for injection
Seasonal inactivated influenza vaccine (SIIV)
Percentage of Participants With Local Reactions Within 10 Days After Vaccination With 20vPnC
Local reactions were collected at the 20vPnC injection sites after Vaccination 1 and Vaccination 2 and were recorded by the participants using an electronic diary (e-diary). Local reactions included redness, swelling and pain at the injection site. 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 with local reactions at the 20vPnC injection site in the Coadministration group and the Separate administration group and the associated 2-sided 95% confidence interval (CI) based on the Clopper and Pearson method was presented.
Time frame: Within 10 days after Vaccination 1 for Coadministration group and within 10 days after Vaccination 2 for Separate Administration group
Percentage of Participants With Systemic Events Within 7 Days After Each Vaccination By Each Vaccine
Systemic events including fever, fatigue, headache, muscle pain and joint pain were recorded by participants using an e-diary. Fever was defined as temperature \>=38.0 degree Celsius (C) and categorized as \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0 degree C. Fatigue, headache, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily routine activity). Percentage of participants with systemic events within 7 days after each vaccination and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented.
Time frame: Within 7 days after each vaccination
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Each Vaccination by Each Vaccine
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time frame: Within 1 month after each vaccination
Percentage of Participants With Serious Adverse Events (SAEs) From the First Vaccination up to 6 Months After Last Vaccination
An SAE was defined as any untoward medical occurrence that, at any dose that results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect or that is considered to be an important medical event. Percentage of participants with SAEs and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented.
Time frame: From Day 1 up to 6 months after last Vaccination (i.e. up to 7 months)
Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) up to 6 Months After Last Vaccination
An NDCMC was defined as a significant 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 NDCMC and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented.
Time frame: Up to 6 months after last Vaccination (i.e. up to 7 months)
Model-Based Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination With 20vPnC
OPA titers were measured from serum samples for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F,8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F. GMTs and 2-sided CIs were calculated by exponentiating the LS means and the corresponding CIs based on analysis of log-transformed OPA titers using a regression model
Time frame: 1 month after the 20vPnC administration in each group (1 month after Vaccination 1 in the Coadministration group and 1 month after Vaccination 2 in the Separate Administration group).
Model-Based Hemagglutination Inhibition (HAI) Strain Specific Geometric Mean Titers (GMT) at 1 Month After Vaccination With SIIV
HAI titers to the influenza strains (A/H1N1, A/H3N2, B/Victoria, and B/Phuket) in the SIIV administered sera samples was collected and reported in this outcome measure at 1 month after Vaccination 1. GMTs and 2-sided CIs were calculated by exponentiating the LS means and the corresponding CIs based on analysis of log-transformed HAI titers using a regression model.
Time frame: At 1 month after Vaccination 1 with SIIV
Percentage of Participants With Greater Than or Equal to (≥4) Fold Rise in Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination With 20vPnC
OPA titers were measured from serum samples for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F,8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F. Percentage of participants with \>=4 fold rise in serotype-specific OPA titers from before vaccination to 1 month after vaccination with 20vPnC and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented.
Time frame: Before Vaccination 1 to 1 month after 20vPnC vaccination in both groups (i.e., 1 month after Vaccination 1 in Coadministration group and 1 month after Vaccination 2 in Separate Administration group)
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination With 20vPnC
OPA titers were measured from serum samples for serotypes: 1, 3, 4, 5, 6A, 6B, 7F,8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F. GMFR was calculated as geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with 20vPnC. GMFRs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the OPA titers or fold rises and the corresponding CIs.
Time frame: Before Vaccination 1 to 1 month after 20vPnC vaccination in both groups (i.e., 1 month after Vaccination 1 in Coadministration group and 1 month after Vaccination 2 in Separate Administration group)
Hemagglutination Inhibition (HAI) Strain Specific Geometric Mean Fold Rise (GMFR) Before Vaccination to 1 Month After Vaccination With SIIV
HAI titers were measured from serum samples for serotypes A/H1N1, A/H3N2, B/Victoria, B/Phuket. GMFR was calculated as geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with SIIV. GMFRs were calculated for participants with non-missing values both before and after vaccination.
Time frame: Before Vaccination 1 to 1 month after Vaccination 1 with SIIV
| Milestone | (SIIV+20vPnC)/Saline: Coadministration | (SIIV+Saline)/20vPnC: Separate Administration |
|---|---|---|
| Started | 898 | 898 |
| Vaccination 1 | 895 | 896 |
| Vaccination 2 | 874 | 878 |
| Completed | 862 | 865 |
| Not completed | 36 | 33 |
| Withdrew: Protocol violation | 3 | 1 |
| Withdrew: Withdrawal by subject | 12 | 9 |
| Withdrew: Other | 1 | 2 |
| Withdrew: Adverse event | 1 | 1 |
| Withdrew: Death | 2 | 3 |
| Withdrew: Lost to follow-up | 9 | 9 |
| Withdrew: No longer meets eligibility criteria | 8 | 8 |
Local reactions were collected at the 20vPnC injection sites after Vaccination 1 and Vaccination 2 and were recorded by the participants using an electronic diary (e-diary). Local reactions included redness, swelling and pain at the injection site. 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 with local reactions at the 20vPnC injection site in the Coadministration group and the Separate administration group and the associated 2-sided 95% confidence interval (CI) based on the Clopper and Pearson method was presented.
| Percentage of participants | (SIIV+20vPnC)/Saline: Coadministration | (SIIV+Saline)/20vPnC: Separate Administration |
|---|---|---|
| Redness: Any | 6.3 (4.8 to 8.1) | 7.4 (5.7 to 9.3) |
| Redness: Mild | 4.0 (2.8 to 5.5) | 3.3 (2.2 to 4.7) |
| Redness: Moderate | 2.1 (1.2 to 3.2) | 3.3 (2.2 to 4.7) |
| Redness: Severe | 0.2 (0.0 to 0.8) | 0.8 (0.3 to 1.7) |
| Swelling: Any | 8.2 (6.5 to 10.2) | 7.8 (6.1 to 9.8) |
| Swelling: Mild | 5.0 (3.7 to 6.7) | 4.4 (3.2 to 6.0) |
| Swelling: Moderate | 2.9 (1.9 to 4.2) | 3.3 (2.2 to 4.7) |
| Swelling: Severe | 0.3 (0.1 to 1.0) | 0.1 (0.0 to 0.6) |
| Pain at the injection site: Any | 48.9 (45.5 to 52.2) | 51.5 (48.1 to 54.9) |
| Pain at the injection site: Mild | 41.0 (37.7 to 44.3) | 42.9 (39.6 to 46.3) |
| Pain at the injection site: Moderate | 7.6 (6.0 to 9.6) | 8.4 (6.6 to 10.5) |
| Pain at the injection site: Severe | 0.2 (0.0 to 0.8) | 0.1 (0.0 to 0.6) |
Systemic events including fever, fatigue, headache, muscle pain and joint pain were recorded by participants using an e-diary. Fever was defined as temperature \>=38.0 degree Celsius (C) and categorized as \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0 degree C. Fatigue, headache, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily routine activity). Percentage of participants with systemic events within 7 days after each vaccination and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented.
| Percentage of participants | 20vPnC Coadministered With SIIV | Separate SIIV Administration | Saline Only | Separate 20vPnC |
|---|---|---|---|---|
| Fever: >=38.0 degree C | 1.5 (0.8 to 2.5) | 0.6 (0.2 to 1.3) | 0.7 (0.3 to 1.5) | 0.5 (0.1 to 1.2) |
| Fever: >=38.0 degree C to 38.4 degree C | 0.9 (0.4 to 1.8) | 0.5 (0.1 to 1.2) | 0.6 (0.2 to 1.4) | 0.4 (0.1 to 1.0) |
| Fever: >38.4 degree C to 38.9 degree C | 0.5 (0.1 to 1.2) | 0.1 (0.0 to 0.6) | 0 (0.0 to 0.4) | 0.1 (0.0 to 0.6) |
| Fever: >38.9 degree C to 40.0 degree C | 0.1 (0.0 to 0.6) | 0 (0.0 to 0.4) | 0.1 (0.0 to 0.7) | 0 (0.0 to 0.4) |
| Fever: >40.0 degree C | 0 (0.0 to 0.4) | 0 (0.0 to 0.4) | 0 (0.0 to 0.4) | 0 (0.0 to 0.4) |
| Fatigue: Any | 33.2 (30.1 to 36.4) | 22.8 (20.0 to 25.7) | 13.2 (11.0 to 15.7) | 20.1 (17.5 to 23.0) |
| Fatigue: Mild | 20.0 (17.4 to 22.8) | 12.6 (10.5 to 14.9) | 8.0 (6.2 to 10.0) | 10.8 (8.8 to 13.0) |
| Fatigue: Moderate | 12.3 (10.2 to 14.7) | 9.6 (7.8 to 11.8) | 4.9 (3.6 to 6.6) | 8.4 (6.6 to 10.5) |
| Fatigue: Severe | 0.9 (0.4 to 1.8) | 0.6 (0.2 to 1.3) | 0.4 (0.1 to 1.0) | 0.9 (0.4 to 1.8) |
| Headache: Any | 21.9 (19.2 to 24.8) | 18.0 (15.5 to 20.7) | 12.0 (9.9 to 14.3) | 15.3 (13.0 to 17.9) |
| Headache: Mild | 16.2 (13.8 to 18.8) | 13.0 (10.9 to 15.4) | 9.1 (7.3 to 11.3) | 10.9 (8.9 to 13.2) |
| Headache: Moderate | 5.5 (4.1 to 7.2) | 5.0 (3.6 to 6.6) | 2.6 (1.6 to 3.9) | 4.1 (2.9 to 5.6) |
| Headache: Severe | 0.2 (0.0 to 0.8) | 0 (0.0 to 0.4) | 0.2 (0.0 to 0.8) | 0.4 (0.1 to 1.0) |
| Muscle Pain: Any | 19.7 (17.1 to 22.5) | 13.7 (11.5 to 16.1) | 8.2 (6.5 to 10.3) | 14.2 (11.9 to 16.7) |
| Muscle Pain: Mild | 11.1 (9.1 to 13.3) | 8.9 (7.1 to 11.0) | 4.2 (3.0 to 5.8) | 8.8 (7.0 to 10.9) |
| Muscle Pain: Moderate | 8.0 (6.3 to 10.0) | 4.5 (3.3 to 6.1) | 3.9 (2.7 to 5.4) | 5.4 (4.0 to 7.1) |
| Muscle Pain: Severe | 0.7 (0.3 to 1.5) | 0.2 (0.0 to 0.8) | 0.1 (0.0 to 0.7) | 0 (0.0 to 0.4) |
| Joint Pain: Any | 13.3 (11.2 to 15.8) | 12.5 (10.4 to 14.8) | 7.7 (6.0 to 9.7) | 10.3 (8.3 to 12.5) |
| Joint Pain: Mild | 6.6 (5.1 to 8.5) | 6.6 (5.0 to 8.4) | 2.7 (1.7 to 4.0) | 6.4 (4.9 to 8.3) |
| Joint Pain: Moderate | 6.5 (5.0 to 8.3) | 5.7 (4.2 to 7.4) | 4.8 (3.5 to 6.5) | 3.6 (2.5 to 5.1) |
| Joint Pain: Severe | 0.2 (0.0 to 0.8) | 0.2 (0.0 to 0.8) | 0.2 (0.0 to 0.8) | 0.2 (0.0 to 0.8) |
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
| Percentage of participants | 20vPnC Coadministered With SIIV | Separate SIIV Administration | Saline Only | Separate 20vPnC |
|---|---|---|---|---|
| Percentage of Participants With Adverse Events (AEs) Within 1 Month After Each Vaccination by Each Vaccine | 9.1 (7.3 to 11.1) | 8.0 (6.3 to 10.0) | 6.3 (4.8 to 8.1) | 8.7 (6.9 to 10.7) |
An SAE was defined as any untoward medical occurrence that, at any dose that results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect or that is considered to be an important medical event. Percentage of participants with SAEs and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented.
| Percentage of participants | (SIIV+20vPnC)/Saline: Coadministration | (SIIV+Saline)/20vPnC: Separate Administration |
|---|---|---|
| Percentage of Participants With Serious Adverse Events (SAEs) From the First Vaccination up to 6 Months After Last Vaccination | 3.7 (2.6 to 5.1) | 3.7 (2.5 to 5.1) |
An NDCMC was defined as a significant 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 NDCMC and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented.
| Percentage of participants | (SIIV+20vPnC)/Saline: Coadministration | (SIIV+Saline)/20vPnC: Separate Administration |
|---|---|---|
| Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) up to 6 Months After Last Vaccination | 3.8 (2.6 to 5.3) | 3.1 (2.1 to 4.5) |
OPA titers were measured from serum samples for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F,8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F. GMTs and 2-sided CIs were calculated by exponentiating the LS means and the corresponding CIs based on analysis of log-transformed OPA titers using a regression model
| Titer | (SIIV+20vPnC)/Saline: Coadministration | (SIIV+Saline)/20vPnC: Separate Administration |
|---|---|---|
| Serotype 1 | 70 (63 to 79) | 95 (85 to 107) |
| Serotype 3 | 38 (34 to 41) | 46 (42 to 50) |
| Serotype 4 | 567 (500 to 642) | 639 (563 to 724) |
| Serotype 5 | 71 (64 to 78) | 81 (73 to 89) |
| Serotype 6A | 753 (657 to 863) | 995 (868 to 1141) |
| Serotype 6B | 855 (754 to 971) | 1050 (923 to 1194) |
| Serotype 7F | 918 (846 to 996) | 1015 (936 to 1101) |
| Serotype 8 | 260 (228 to 296) | 323 (284 to 368) |
| Serotype 9V | 1261 (1115 to 1426) | 1344 (1189 to 1519) |
| Serotype 10A | 1391 (1213 to 1595) | 1681 (1468 to 1925) |
| Serotype 11A | 1032 (886 to 1202) | 1453 (1249 to 1690) |
| Serotype 12F | 1352 (1161 to 1574) | 1652 (1415 to 1929) |
| Serotype 14 | 514 (463 to 571) | 600 (540 to 667) |
| Serotype 15B | 839 (695 to 1012) | 1202 (997 to 1450) |
| Serotype 18C | 825 (723 to 943) | 920 (805 to 1051) |
| Serotype 19A | 467 (420 to 519) | 534 (480 to 593) |
| Serotype 19F | 241 (215 to 270) | 272 (243 to 305) |
| Serotype 22F | 2192 (1850 to 2597) | 2933 (2481 to 3468) |
| Serotype 23F | 247 (213 to 287) | 318 (273 to 369) |
| Serotype 33F | 3047 (2672 to 3475) | 4259 (3737 to 4853) |
HAI titers to the influenza strains (A/H1N1, A/H3N2, B/Victoria, and B/Phuket) in the SIIV administered sera samples was collected and reported in this outcome measure at 1 month after Vaccination 1. GMTs and 2-sided CIs were calculated by exponentiating the LS means and the corresponding CIs based on analysis of log-transformed HAI titers using a regression model.
| Titer | (SIIV+20vPnC)/Saline: Coadministration | (SIIV+Saline)/20vPnC: Separate Administration |
|---|---|---|
| A/H1N1 | 51.9 (47.6 to 56.6) | 48.7 (44.7 to 53.0) |
| A/H3N2 | 189.8 (173.9 to 207.2) | 193.4 (177.3 to 211.0) |
| B/Victoria | 68.1 (63.4 to 73.1) | 68.0 (63.4 to 73.0) |
| B/Phuket | 39.4 (36.3 to 42.6) | 41.6 (38.4 to 45.0) |
OPA titers were measured from serum samples for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F,8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F. Percentage of participants with \>=4 fold rise in serotype-specific OPA titers from before vaccination to 1 month after vaccination with 20vPnC and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented.
| Percentage of participants | (SIIV+20vPnC)/Saline: Coadministration | (SIIV+Saline)/20vPnC: Separate Administration |
|---|---|---|
| Serotype 1 | 32.9 (29.7 to 36.2) | 42.0 (38.6 to 45.4) |
| Serotype 3 | 31.1 (28.0 to 34.4) | 39.7 (36.3 to 43.1) |
| Serotype 4 | 45.3 (41.9 to 48.8) | 48.5 (45.0 to 52.0) |
| Serotype 5 | 28.2 (25.2 to 31.4) | 32.7 (29.5 to 36.0) |
| Serotype 6A | 57.7 (54.2 to 61.1) | 62.9 (59.4 to 66.2) |
| Serotype 6B | 51.7 (48.2 to 55.2) | 55.3 (51.8 to 58.8) |
| Serotype 7F | 26.5 (23.5 to 29.6) | 29.3 (26.2 to 32.6) |
| Serotype 8 | 52.1 (48.5 to 55.6) | 53.8 (50.2 to 57.3) |
| Serotype 9V | 41.4 (38.0 to 44.9) | 43.6 (40.1 to 47.1) |
| Serotype 10A | 56.5 (52.9 to 60.1) | 62.0 (58.4 to 65.5) |
| Serotype 11A | 43.5 (39.8 to 47.2) | 50.6 (46.8 to 54.4) |
| Serotype 12F | 60.1 (56.6 to 63.6) | 63.6 (60.0 to 67.0) |
| Serotype 14 | 24.8 (21.8 to 27.9) | 30.3 (27.2 to 33.6) |
| Serotype 15B | 56.7 (53.1 to 60.3) | 60.8 (57.2 to 64.3) |
| Serotype 18C | 39.3 (35.9 to 42.7) | 42.7 (39.2 to 46.1) |
| Serotype 19A | 36.0 (32.8 to 39.4) | 40.2 (36.8 to 43.7) |
| Serotype 19F | 33.9 (30.7 to 37.2) | 38.6 (35.3 to 42.1) |
| Serotype 22F | 68.7 (65.1 to 72.1) | 72.0 (68.5 to 75.3) |
| Serotype 23F | 49.8 (46.3 to 53.2) | 55.1 (51.6 to 58.5) |
| Serotype 33F | 39.1 (35.6 to 42.7) | 47.7 (44.1 to 51.4) |
OPA titers were measured from serum samples for serotypes: 1, 3, 4, 5, 6A, 6B, 7F,8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F. GMFR was calculated as geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with 20vPnC. GMFRs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the OPA titers or fold rises and the corresponding CIs.
| Fold rise | (SIIV+20vPnC)/Saline: Coadministration | (SIIV+Saline)/20vPnC: Separate Administration |
|---|---|---|
| Serotype 1 | 3.0 (2.8 to 3.3) | 4.0 (3.6 to 4.5) |
| Serotype 3 | 2.5 (2.3 to 2.7) | 3.1 (2.8 to 3.3) |
| Serotype 4 | 6.2 (5.4 to 7.1) | 7.4 (6.4 to 8.5) |
| Serotype 5 | 2.4 (2.2 to 2.6) | 2.7 (2.5 to 3.0) |
| Serotype 6A | 8.8 (7.7 to 10.1) | 11.9 (10.4 to 13.7) |
| Serotype 6B | 6.5 (5.8 to 7.3) | 8.4 (7.4 to 9.5) |
| Serotype 7F | 2.6 (2.4 to 2.8) | 2.8 (2.5 to 3.1) |
| Serotype 8 | 5.8 (5.1 to 6.6) | 7.3 (6.3 to 8.3) |
| Serotype 9V | 4.0 (3.6 to 4.5) | 4.3 (3.8 to 4.8) |
| Serotype 10A | 8.0 (7.0 to 9.2) | 10.1 (8.8 to 11.6) |
| Serotype 11A | 4.4 (3.9 to 5.1) | 6.2 (5.3 to 7.1) |
| Serotype 12F | 11.4 (9.7 to 13.3) | 14.4 (12.2 to 17.0) |
| Serotype 14 | 2.5 (2.3 to 2.8) | 3.0 (2.7 to 3.4) |
| Serotype 15B | 11.7 (9.9 to 14.0) | 16.4 (13.6 to 19.8) |
| Serotype 18C | 4.6 (4.0 to 5.2) | 5.2 (4.5 to 5.9) |
| Serotype 19A | 3.7 (3.3 to 4.1) | 4.2 (3.8 to 4.7) |
| Serotype 19F | 3.0 (2.7 to 3.3) | 3.3 (3.0 to 3.7) |
| Serotype 22F | 23.6 (19.4 to 28.6) | 32.3 (26.5 to 39.4) |
| Serotype 23F | 6.4 (5.6 to 7.2) | 8.5 (7.4 to 9.7) |
| Serotype 33F | 3.3 (3.0 to 3.7) | 4.8 (4.2 to 5.4) |
HAI titers were measured from serum samples for serotypes A/H1N1, A/H3N2, B/Victoria, B/Phuket. GMFR was calculated as geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with SIIV. GMFRs were calculated for participants with non-missing values both before and after vaccination.
| Fold rise | (SIIV+20vPnC)/Saline: Coadministration | (SIIV+Saline)/20vPnC: Separate Administration |
|---|---|---|
| A/H1N1 | 1.8 (1.7 to 2.0) | 1.8 (1.6 to 2.0) |
| A/H3N2 | 2.0 (1.8 to 2.2) | 2.0 (1.8 to 2.2) |
| B/Victoria | 1.7 (1.6 to 1.8) | 1.7 (1.6 to 1.9) |
| B/Phuket | 1.4 (1.3 to 1.5) | 1.4 (1.3 to 1.5) |
Collected over Local reactions(systematic assessment): within 10 days after Vaccination 1 for Coadministration group and within 10 days after Vaccination 2 for Separate Administration group, Systemic events(systematic assessment): within 7 days after Vaccination 1 for Coadministration group and within 7 days after Vaccination 2 for Separate Administration group, SAEs: from Day 1 up to 6 months after last vaccination(i.e., up to 7 months) and other AEs: up to 1 month after each vaccination. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| (SIIV+20vPnC)/Saline: Coadministration | 2/895 (0.2%) | 33/895 (3.7%) | 629/895 (70.3%) |
| (SIIV+Saline)/20vPnC: Separate Administration | 3/896 (0.3%) | 33/896 (3.7%) | 644/896 (71.9%) |
| Event | (SIIV+20vPnC)/Saline: Coadministration | (SIIV+Saline)/20vPnC: Separate Administration |
|---|---|---|
| COVID-19 pneumoniaInfections and infestations | 3/895 | 1/896 |
| Acute respiratory failureRespiratory, thoracic and mediastinal disorders | 3/895 | 1/896 |
| COVID-19Infections and infestations | 1/895 | 3/896 |
| Atrial fibrillationCardiac disorders | 2/895 | 1/896 |
| Atrioventricular block completeCardiac disorders | 2/895 | 1/896 |
| Chest painGeneral disorders | 2/895 | 2/896 |
| Femur fractureInjury, poisoning and procedural complications | 2/895 | 0/896 |
| Prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/895 | 0/896 |
| Acute kidney injuryRenal and urinary disorders | 2/895 | 1/896 |
| SyncopeNervous system disorders | 0/895 | 2/896 |
| Event | (SIIV+20vPnC)/Saline: Coadministration | (SIIV+Saline)/20vPnC: Separate Administration |
|---|---|---|
| Injection site pain (PAIN)General disorders | 440/895 | 461/896 |
| Fatigue (FATIGUE)General disorders | 332/895 | 299/896 |
| Headache (HEADACHE)Nervous system disorders | 241/895 | 231/896 |
| Myalgia (MUSCLE PAIN)Musculoskeletal and connective tissue disorders | 207/895 | 199/896 |
| Arthralgia (JOINT PAIN)Musculoskeletal and connective tissue disorders | 148/895 | 155/896 |
| Injection site swelling (SWELLING)General disorders | 73/895 | 76/896 |
| Injection site erythema (REDNESS)General disorders | 57/895 | 67/896 |
| SARS-CoV-2 test positiveInvestigations | 14/895 | 20/896 |
| COVID-19Infections and infestations | 12/895 | 18/896 |
| Pyrexia (FEVER)General disorders | 17/895 | 9/896 |
Safety population included all randomized participants who received 1 dose of 20vPnC or SIIV or saline and had safety follow-up after any dose.
| Age, Continuous(Years) | (SIIV+20vPnC)/Saline: Coadministration | (SIIV+Saline)/20vPnC: Separate Administration | Total |
|---|---|---|---|
| Mean | 72.1 ± 5.49 | 71.9 ± 5.48 | 72.0 ± 5.49 |
| Sex: Female, Male(Participants) | (SIIV+20vPnC)/Saline: Coadministration | (SIIV+Saline)/20vPnC: Separate Administration | Total |
|---|---|---|---|
| Female | 483 | 496 | 979 |
| Male | 412 | 400 | 812 |
| Ethnicity (NIH/OMB)(Participants) | (SIIV+20vPnC)/Saline: Coadministration | (SIIV+Saline)/20vPnC: Separate Administration | Total |
|---|---|---|---|
| Hispanic or Latino | 92 | 77 | 169 |
| Not Hispanic or Latino | 793 | 813 | 1606 |
| Unknown or Not Reported | 10 | 6 | 16 |
| Race (NIH/OMB)(Participants) | (SIIV+20vPnC)/Saline: Coadministration | (SIIV+Saline)/20vPnC: Separate Administration | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 2 | 3 |
| Asian | 7 | 15 | 22 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 58 | 65 | 123 |
| White | 816 | 807 | 1623 |
| More than one race | 10 | 3 | 13 |
| Unknown or Not Reported | 3 | 4 | 7 |
Documents are hosted by the registry — open the source record to download them.
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.
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