Trial · NCT03828617
Trial to Evaluate the Safety and Immunogenicity of 3 Lots of 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults
NCT03828617, Phase 3, Completed, Pfizer; results first posted 2020-11-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Trial to Evaluate the Safety and Immunogenicity of 3 Lots of 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults. Trials, record NCT03828617. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03828617
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial to Evaluate the Safety and Immunogenicity of 3 Lots of 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults
- NCT number
- NCT03828617
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,710 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Pneumococcal Disease
- Interventions
- 20vPnC, 20vPnC, 20vPnC, 13vPnC
- First posted
- 2019-02-04
- Last updated
- 2020-11-23
- Results first posted
- 2020-11-04
Source ClinicalTrials.gov
Registered outcomes9
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 | Within 10 days after vaccination | Local reactions were recorded using an electronic 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). Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group. |
| Primary | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Within 7 days after vaccination | Systemic events fever, fatigue, headache, muscle pain, joint pain were recorded by using an electronic diary. Fever was defined as greater than or equal to (\>=) 38.0 degree Celsius (C) and categorized to \>=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). Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group. |
| Primary | Percentage of Participants With Any Adverse Events (AEs) Within 1 Month After Vaccination | Within 1 month after vaccination | An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship. Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group. |
| Primary | Percentage of Participants With Any Serious Adverse Events (SAEs) Within 6 Months After Vaccination | Within 6 month after vaccination | An SAE was any untoward medical occurrence 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 or significant 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. Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group. |
| Primary | Percentage of Participants With Any Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination | Within 6 months after vaccination | An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects. Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group. |
| Primary | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | 1 month after vaccination | OPA titers were determined for serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. OPA titer was expressed as reciprocal of the highest serum dilution. OPA GMTs and 2-sided 95% CIs were calculated. Data for this outcome measure were planned to be analyzed for the 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) only. |
| Secondary | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Before vaccination to 1 month after vaccination | Fold rises are the ratios of the 1 month after vaccination to before vaccination OPA titers. OPA GMFRs from before to 1 month after vaccination were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. Data for this outcome measure was planned to be analyzed for the 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) only. |
| Secondary | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Before vaccination to 1 month after vaccination | Percentage of participants with a \>=4-fold rise in serotype-specific pneumococcal OPA titers from before vaccination to 1 month after vaccination along with corresponding 2-sided 95% CIs were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. Data for this outcome measure was planned to be analyzed for the 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) only. |
| Secondary | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | 1 month after vaccination | The percentage of participants with OPA titers \>=LLOQ were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. Data for this outcome measure was planned to be analyzed for the 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) only. |
Source ClinicalTrials.gov
Outcomes9
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 | Within 10 days after vaccination | Safety population included all participants who received 1 dose of any 20vPnC lot or 13vPnC and had safety follow-up after the vaccination. Here, Overall Number of Participants Analyzed = participants evaluable for this outcome measure. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Within 7 days after vaccination | Safety population included all participants who received 1 dose of any 20vPnC lot or 13vPnC and had safety follow-up after the vaccination. Here, Overall Number of Participants Analyzed = participants evaluable for this outcome measure. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Any Adverse Events (AEs) Within 1 Month After Vaccination | Within 1 month after vaccination | Safety population included all participants who received 1 dose of any 20vPnC lot or 13vPnC and had safety follow-up after the vaccination. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Any Serious Adverse Events (SAEs) Within 6 Months After Vaccination | Within 6 month after vaccination | Safety population includes all participants who received 1 dose of any 20vPnC lot or 13vPnC and had safety follow-up after the vaccination. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Any Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination | Within 6 months after vaccination | Safety population included all participants who received 1 dose of any 20vPnC lot or 13vPnC and had safety follow-up after the vaccination. | percentage of participants | NUMBER |
| PRIMARY | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | 1 month after vaccination | EIP: participants who received randomized vaccine, had blood collection within 27 to 49 days after vaccination (Visit 2), had at least 1 valid and determinate OPA titer for any serotype at Visit 2, and had no other major protocol deviations. Here, Number analyzed = participants evaluable for this outcome measure at specified rows. | titer | GEOMETRIC_MEAN |
| SECONDARY | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Before vaccination to 1 month after vaccination | EIP: participants who received randomized vaccine, had blood collection within 27 to 49 days after vaccination (Visit 2), had at least 1 valid and determinate OPA titer for any serotype at Visit 2, and had no other major protocol deviations. Here, Number analyzed = participants evaluable for this outcome measure at specified rows. | fold rise | GEOMETRIC_MEAN |
| SECONDARY | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Before vaccination to 1 month after vaccination | EIP: participants who received randomized vaccine, had blood collection within 27 to 49 days after vaccination (Visit 2), had at least 1 valid and determinate OPA titer for any serotype at Visit 2, and had no other major protocol deviations. Here, Number analyzed = participants evaluable for this outcome measure at specified rows. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | 1 month after vaccination | EIP: participants who received randomized vaccine, had blood collection within 27 to 49 days after vaccination (Visit 2), had at least 1 valid and determinate OPA titer for any serotype at Visit 2, and had no other major protocol deviations. Here, Number analyzed = participants evaluable for this outcome measure at specified rows. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group312
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 | Pooled 20vPnC | Redness: Any | 7.0 | 95% Confidence Interval 5.7 to 8.4 | percentage of participants |
| Percentage of Participants With Local Reactions Within 10 Days After Vaccination | 13vPnC | Redness: Any | 6.2 | 95% Confidence Interval 3.5 to 10.0 | percentage of participants |
| Percentage of Participants With Local Reactions Within 10 Days After Vaccination | Pooled 20vPnC | Redness: Mild | 3.9 | 95% Confidence Interval 3.0 to 5.0 | percentage of participants |
| Percentage of Participants With Local Reactions Within 10 Days After Vaccination | 13vPnC | Redness: Mild | 3.3 | 95% Confidence Interval 1.4 to 6.4 | percentage of participants |
| Percentage of Participants With Local Reactions Within 10 Days After Vaccination | Pooled 20vPnC | Redness: Moderate | 2.6 | 95% Confidence Interval 1.9 to 3.6 | percentage of participants |
| Percentage of Participants With Local Reactions Within 10 Days After Vaccination | 13vPnC | Redness: Moderate | 2.9 | 95% Confidence Interval 1.2 to 5.8 | percentage of participants |
| Percentage of Participants With Local Reactions Within 10 Days After Vaccination | Pooled 20vPnC | Redness: Severe | 0.5 | 95% Confidence Interval 0.2 to 1.0 | percentage of participants |
| Percentage of Participants With Local Reactions Within 10 Days After Vaccination | 13vPnC | Redness: Severe | 0 | 95% Confidence Interval 0.0 to 1.5 | percentage of participants |
| Percentage of Participants With Local Reactions Within 10 Days After Vaccination | Pooled 20vPnC | Swelling: Any | 8.5 | 95% Confidence Interval 7.1 to 10.1 | percentage of participants |
| Percentage of Participants With Local Reactions Within 10 Days After Vaccination | 13vPnC | Swelling: Any | 8.6 | 95% Confidence Interval 5.4 to 12.9 | percentage of participants |
1 to 10 of 312Source ClinicalTrials.gov
See all 312 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 20vPnC Lot 1 | 489 | |
| Overall Study | STARTED | 20vPnC Lot 2 | 490 | |
| Overall Study | STARTED | 20vPnC Lot 3 | 486 | |
| Overall Study | STARTED | 13vPnC | 245 | |
| Overall Study | Vaccinated | 20vPnC Lot 1 | 488 | |
| Overall Study | Vaccinated | 20vPnC Lot 2 | 489 | |
| Overall Study | Vaccinated | 20vPnC Lot 3 | 486 | |
| Overall Study | Vaccinated | 13vPnC | 245 | |
| Overall Study | Safety Population | 20vPnC Lot 1 | 488 | |
| Overall Study | Safety Population | 20vPnC Lot 2 | 489 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events44
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 | General disorders | Pooled 20vPnC | 693 | 1,463 | |
| other | Fatigue | General disorders | 13vPnC | 106 | 245 | |
| other | Injection site erythema (REDNESS) | General disorders | Pooled 20vPnC | 102 | 1,463 | |
| other | Injection site erythema (REDNESS) | General disorders | 13vPnC | 15 | 245 | |
| other | Injection site pain (PAIN) | General disorders | Pooled 20vPnC | 1,146 | 1,463 | |
| other | Injection site pain (PAIN) | General disorders | 13vPnC | 184 | 245 | |
| other | Injection site swelling (SWELLING) | General disorders | Pooled 20vPnC | 124 | 1,463 | |
| other | Injection site swelling (SWELLING) | General disorders | 13vPnC | 21 | 245 | |
| other | Pyrexia (FEVER) | General disorders | Pooled 20vPnC | 18 | 1,463 | |
| other | Pyrexia (FEVER) | General disorders | 13vPnC | 2 | 245 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pooled 20vPnC | 0 | 1,463 |
| Total, all-cause mortality | 13vPnC | 0 | 245 |
| Total, other adverse events | Pooled 20vPnC | 1,275 | 1,463 |
| Total, other adverse events | 13vPnC | 206 | 245 |
| Total, serious adverse events | Pooled 20vPnC | 10 | 1,463 |
| Total, serious adverse events | 13vPnC | 0 | 245 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|---|
| Pooled 20vPnC vs 13vPnC: deaths from any cause | Trial comparisons |
| Pooled 20vPnC vs 13vPnC: 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/NCT03828617
GET https://conductscience.org/api/trials/v1/NCT03828617/results?page=2