Trial · NCT04526574
Safety and Immunogenicity of 20vPnC Coadministered With SIIV in Adults ≥65 Years of Age
NCT04526574, Phase 3, Completed, Pfizer; results first posted 2022-07-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Immunogenicity of 20vPnC Coadministered With SIIV in Adults ≥65 Years of Age. Trials, record NCT04526574. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04526574
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Immunogenicity of 20vPnC Coadministered With SIIV in Adults ≥65 Years of Age
- NCT number
- NCT04526574
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,796 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Pneumococcal Disease
- Interventions
- Experimental 20-valent pneumococcal conjugate vaccine (20vPnC), Saline, Influenza vaccine
- First posted
- 2020-08-26
- Last updated
- 2022-07-08
- Results first posted
- 2022-07-08
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Local Reactions Within 10 Days After Vaccination With 20vPnC | Within 10 days after Vaccination 1 for Coadministration group and within 10 days after Vaccination 2 for Separate Administration group | 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. |
| Primary | Percentage of Participants With Systemic Events Within 7 Days After Each Vaccination By Each Vaccine | Within 7 days after each vaccination | 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. |
| Primary | Percentage of Participants With Adverse Events (AEs) Within 1 Month After Each Vaccination by Each Vaccine | Within 1 month after each vaccination | 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. |
| Primary | Percentage of Participants With Serious Adverse Events (SAEs) From the First Vaccination up to 6 Months After Last Vaccination | From Day 1 up to 6 months after last Vaccination (i.e. up to 7 months) | 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. |
| Primary | Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) up to 6 Months After Last Vaccination | Up to 6 months after last Vaccination (i.e. up to 7 months) | 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. |
| Primary | Model-Based Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination With 20vPnC | 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). | 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 |
| Primary | Model-Based Hemagglutination Inhibition (HAI) Strain Specific Geometric Mean Titers (GMT) at 1 Month After Vaccination With SIIV | At 1 month after Vaccination 1 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. |
| Secondary | 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 | 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) | 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. |
| Secondary | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination With 20vPnC | 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) | 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. |
| Secondary | Hemagglutination Inhibition (HAI) Strain Specific Geometric Mean Fold Rise (GMFR) Before Vaccination to 1 Month After Vaccination With SIIV | Before Vaccination 1 to 1 month after Vaccination 1 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. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Local Reactions Within 10 Days After Vaccination With 20vPnC | Within 10 days after Vaccination 1 for Coadministration group and within 10 days after Vaccination 2 for Separate Administration group | Safety population included all randomized participants who received 1 dose of 20vPnC or SIIV or saline and had safety follow-up after any dose. Here, Overall Number of Participants Analyzed (N) signifies number of participants with any e-diary data reported after vaccination with 20vPnC. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Systemic Events Within 7 Days After Each Vaccination By Each Vaccine | Within 7 days after each vaccination | Safety population included all randomized participants who received 1 dose of 20vPnC or SIIV or saline and had safety follow-up after any dose. Here, 'N' signifies number of participants with any e-diary data reported after the vaccination at the specified visit. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Adverse Events (AEs) Within 1 Month After Each Vaccination by Each Vaccine | Within 1 month after each vaccination | Safety population included all randomized participants who received 1 dose of 20vPnC or SIIV or saline and had safety follow-up after any dose. Here, 'Overall number of participants analyzed' (N) is the number of participants included in the safety population who received the specified vaccination. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Serious Adverse Events (SAEs) From the First Vaccination up to 6 Months After Last Vaccination | From Day 1 up to 6 months after last Vaccination (i.e. up to 7 months) | Safety population included all randomized participants who received 1 dose of 20vPnC or SIIV or saline and had safety follow-up after any dose. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) up to 6 Months After Last Vaccination | Up to 6 months after last Vaccination (i.e. up to 7 months) | Safety population included all randomized participants who received 1 dose of 20vPnC or SIIV or saline and had safety follow-up after any dose. | Percentage of participants | NUMBER |
| PRIMARY | Model-Based Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination With 20vPnC | 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). | Evaluable pneumococcal immunogenicity(EPI) population: all randomized participants who received assigned vaccinations; blood collected within 27 to 49 days after 20vPnC; with least 1 valid OPA result from sample collected 1 month after 20vPnC vaccination; had no other major protocol deviations as determined by clinician. Here,'N':number of participants in evaluable immunogenicity population and 'number analyzed': number of evaluable participants with a valid OPA titer for the specified serotype. | Titer | GEOMETRIC_MEAN |
| PRIMARY | Model-Based Hemagglutination Inhibition (HAI) Strain Specific Geometric Mean Titers (GMT) at 1 Month After Vaccination With SIIV | At 1 month after Vaccination 1 with SIIV | Evaluable HAI immunogenicity population: all randomized participants who received assigned vaccinations; had blood collected within 27 to 49 days after SIIV; had at least 1 valid HAI result from blood sample collected 1 month after SIIV vaccination; had no other major protocol deviations as determined by clinician. Here, 'N': number of participants in evaluable HAI immunogenicity population, 'number analyzed': number of evaluable HAI participants with a valid result for the specified HAI strain. | Titer | GEOMETRIC_MEAN |
| SECONDARY | 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 | 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) | EPI population: all randomized participants who received assigned vaccinations; blood collected within 27 to 49 days after 20vPnC with at least 1 valid OPA result from sample collected 1 month after 20vPnC vaccination; no other major protocol deviations as determined by clinician. Here, 'N': number of participants with valid results for both timepoints (before Vaccination 1 and 1 month after 20vPnC), 'number analyzed': participants evaluable for specific serotypes. | Percentage of participants | NUMBER |
| SECONDARY | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination With 20vPnC | 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) | EPI population: all randomized participants who received assigned vaccinations; blood collected within 27 to 49 days after 20vPnC with at least 1 valid OPA result from sample collected 1 month after 20vPnC vaccination; no other major protocol deviations as determined by clinician. Here, 'N': number of participants in the EPI, 'number analyzed': participants with valid OPA titers both before vaccination at Visit 1 and 1 month after 20vPnC blood sample collections. | Fold rise | GEOMETRIC_MEAN |
| SECONDARY | Hemagglutination Inhibition (HAI) Strain Specific Geometric Mean Fold Rise (GMFR) Before Vaccination to 1 Month After Vaccination With SIIV | Before Vaccination 1 to 1 month after Vaccination 1 with SIIV | Evaluable HAI immunogenicity population:randomized participants who received assigned vaccinations; blood collected within 27 to 49 days after SIIV;had at least 1 valid HAI result from blood sample collected 1 month after SIIV vaccination; no other major protocol deviations as determined by clinician. 'N': participants analyzed in HAI immunogenicity population, 'number analyzed':participants with valid HAI titers both before vaccination at Visit 1 and 1 month after SIIV blood sample collections. | Fold rise | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group252
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Local Reactions Within 10 Days After Vaccination With 20vPnC | (SIIV+20vPnC)/Saline: Coadministration | Redness: Any | 6.3 | 95% Confidence Interval 4.8 to 8.1 | Percentage of participants |
| Percentage of Participants With Local Reactions Within 10 Days After Vaccination With 20vPnC | (SIIV+Saline)/20vPnC: Separate Administration | Redness: Any | 7.4 | 95% Confidence Interval 5.7 to 9.3 | Percentage of participants |
| Percentage of Participants With Local Reactions Within 10 Days After Vaccination With 20vPnC | (SIIV+20vPnC)/Saline: Coadministration | Redness: Mild | 4.0 | 95% Confidence Interval 2.8 to 5.5 | Percentage of participants |
| Percentage of Participants With Local Reactions Within 10 Days After Vaccination With 20vPnC | (SIIV+Saline)/20vPnC: Separate Administration | Redness: Mild | 3.3 | 95% Confidence Interval 2.2 to 4.7 | Percentage of participants |
| Percentage of Participants With Local Reactions Within 10 Days After Vaccination With 20vPnC | (SIIV+20vPnC)/Saline: Coadministration | Redness: Moderate | 2.1 | 95% Confidence Interval 1.2 to 3.2 | Percentage of participants |
| Percentage of Participants With Local Reactions Within 10 Days After Vaccination With 20vPnC | (SIIV+Saline)/20vPnC: Separate Administration | Redness: Moderate | 3.3 | 95% Confidence Interval 2.2 to 4.7 | Percentage of participants |
| Percentage of Participants With Local Reactions Within 10 Days After Vaccination With 20vPnC | (SIIV+20vPnC)/Saline: Coadministration | Redness: Severe | 0.2 | 95% Confidence Interval 0.0 to 0.8 | Percentage of participants |
| Percentage of Participants With Local Reactions Within 10 Days After Vaccination With 20vPnC | (SIIV+Saline)/20vPnC: Separate Administration | Redness: Severe | 0.8 | 95% Confidence Interval 0.3 to 1.7 | Percentage of participants |
| Percentage of Participants With Local Reactions Within 10 Days After Vaccination With 20vPnC | (SIIV+20vPnC)/Saline: Coadministration | Swelling: Any | 8.2 | 95% Confidence Interval 6.5 to 10.2 | Percentage of participants |
| Percentage of Participants With Local Reactions Within 10 Days After Vaccination With 20vPnC | (SIIV+Saline)/20vPnC: Separate Administration | Swelling: Any | 7.8 | 95% Confidence Interval 6.1 to 9.8 | Percentage of participants |
1 to 10 of 252Source ClinicalTrials.gov
See all 252 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | (SIIV+20vPnC)/Saline: Coadministration | 898 | |
| Overall Study | STARTED | (SIIV+Saline)/20vPnC: Separate Administration | 898 | |
| Overall Study | Vaccination 1 | (SIIV+20vPnC)/Saline: Coadministration | 895 | |
| Overall Study | Vaccination 1 | (SIIV+Saline)/20vPnC: Separate Administration | 896 | |
| Overall Study | Vaccination 2 | (SIIV+20vPnC)/Saline: Coadministration | 874 | |
| Overall Study | Vaccination 2 | (SIIV+Saline)/20vPnC: Separate Administration | 878 | |
| Overall Study | COMPLETED | (SIIV+20vPnC)/Saline: Coadministration | 862 | |
| Overall Study | COMPLETED | (SIIV+Saline)/20vPnC: Separate Administration | 865 | |
| Overall Study | NOT COMPLETED | (SIIV+20vPnC)/Saline: Coadministration | 36 | |
| Overall Study | NOT COMPLETED | (SIIV+Saline)/20vPnC: Separate Administration | 33 |
Source ClinicalTrials.gov
Adverse events144
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Fatigue (FATIGUE) | General disorders | (SIIV+20vPnC)/Saline: Coadministration | 332 | 895 | |
| other | Fatigue (FATIGUE) | General disorders | (SIIV+Saline)/20vPnC: Separate Administration | 299 | 896 | |
| other | Injection site erythema (REDNESS) | General disorders | (SIIV+20vPnC)/Saline: Coadministration | 57 | 895 | |
| other | Injection site erythema (REDNESS) | General disorders | (SIIV+Saline)/20vPnC: Separate Administration | 67 | 896 | |
| other | Injection site pain (PAIN) | General disorders | (SIIV+20vPnC)/Saline: Coadministration | 440 | 895 | |
| other | Injection site pain (PAIN) | General disorders | (SIIV+Saline)/20vPnC: Separate Administration | 461 | 896 | |
| other | Injection site swelling (SWELLING) | General disorders | (SIIV+20vPnC)/Saline: Coadministration | 73 | 895 | |
| other | Injection site swelling (SWELLING) | General disorders | (SIIV+Saline)/20vPnC: Separate Administration | 76 | 896 | |
| other | Pyrexia (FEVER) | General disorders | (SIIV+20vPnC)/Saline: Coadministration | 17 | 895 | |
| other | Pyrexia (FEVER) | General disorders | (SIIV+Saline)/20vPnC: Separate Administration | 9 | 896 |
1 to 10 of 144Source ClinicalTrials.gov
See all 144 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | (SIIV+20vPnC)/Saline: Coadministration | 2 | 895 |
| Total, all-cause mortality | (SIIV+Saline)/20vPnC: Separate Administration | 3 | 896 |
| Total, other adverse events | (SIIV+20vPnC)/Saline: Coadministration | 629 | 895 |
| Total, other adverse events | (SIIV+Saline)/20vPnC: Separate Administration | 644 | 896 |
| Total, serious adverse events | (SIIV+20vPnC)/Saline: Coadministration | 33 | 895 |
| Total, serious adverse events | (SIIV+Saline)/20vPnC: Separate Administration | 33 | 896 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36828719 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| (SIIV+20vPnC)/Saline: Coadministration vs (SIIV+Saline)/20vPnC: Separate Administration: deaths from any cause | Trial comparisons |
| (SIIV+20vPnC)/Saline: Coadministration vs (SIIV+Saline)/20vPnC: Separate Administration: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04526574
GET https://conductscience.org/api/trials/v1/NCT04526574/results?page=2