Trial ยท NCT04379713
20-valent Pneumococcal Conjugate Vaccine Safety Study in Healthy Infants
NCT04379713, Phase 3, Completed, Pfizer; results first posted 2023-06-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 20-valent Pneumococcal Conjugate Vaccine Safety Study in Healthy Infants. Trials, record NCT04379713. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04379713
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 20-valent Pneumococcal Conjugate Vaccine Safety Study in Healthy Infants
- NCT number
- NCT04379713
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,511 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Pneumococcal Disease
- Interventions
- 20-valent pneumococcal conjugate vaccine, 13-valent pneumococcal conjugate vaccine
- First posted
- 2020-05-07
- Last updated
- 2023-06-13
- Other registries' IDs
- eudract:2019-003307-35
- Results first posted
- 2023-06-13
Source ClinicalTrials.gov
Registered outcomes12
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 7 Days After Dose 1 | Within 7 Days after Dose 1 | Local reactions included pain at injection site, redness and swelling, recorded by parent's/legal guardians of participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild: greater than (\>) 0.0 to 2.0 cm; moderate: \>2.0 to 7.0 cm; and severe: \>7.0 cm. Pain at injection site was graded as mild: hurt if gently touched; moderate: hurt if gently touched with crying; severe: limited limb movement. |
| Primary | Percentage of Participants With Local Reactions Within 7 Days After Dose 2 | Within 7 Days after Dose 2 | Local reactions included pain at injection site, redness and swelling, recorded by parent's/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild: \>0.0 to 2.0 cm; moderate: \>2.0 to 7.0 cm; and severe: \>7.0 cm. Pain at injection site was graded as mild: hurt if gently touched; moderate: hurt if gently touched with crying; severe: limited limb movement. |
| Primary | Percentage of Participants With Local Reactions Within 7 Days After Dose 3 | Within 7 Days after Dose 3 | Local reactions included pain at injection site, redness and swelling, recorded by parent's/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild: \>0.0 to 2.0 cm; moderate: \>2.0 to 7.0 cm; and severe: \>7.0 cm. Pain at injection site was graded as mild: hurt if gently touched; moderate: hurt if gently touched with crying; severe: limited limb movement. |
| Primary | Percentage of Participants With Local Reactions Within 7 Days After Dose 4 | Within 7 Days after Dose 4 | Local reactions included pain at injection site, redness and swelling, recorded by parent's/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild: \>0.0 to 2.0 cm; moderate: \>2.0 to 7.0 cm; and severe: \>7.0 cm. Pain at injection site was graded as mild: hurt if gently touched; moderate: hurt if gently touched with crying; severe: limited limb movement. |
| Primary | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Within 7 Days after Dose 1 | Systemic events included fever, decreased appetite, drowsiness, and irritability. Fever was defined as temperature greater than or equal to (\>=) 38.0 degrees Celsius (C) and categorized as \>=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. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). |
| Primary | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Within 7 Days after Dose 2 | Systemic events included fever, decreased appetite, drowsiness, and irritability. Fever was defined as temperature \>=38.0 degrees C and categorized as \>=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. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). |
| Primary | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Within 7 Days after Dose 3 | Systemic events included fever, decreased appetite, drowsiness, and irritability. Fever was defined as temperature \>=38.0 degrees C and categorized as \>=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. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). |
| Primary | Percentage of Participants With Systemic Events Within 7 Days After Dose 4 | Within 7 Days after Dose 4 | Systemic events included fever, decreased appetite, drowsiness, and irritability. Fever was defined as temperature \>=38.0 degrees C and categorized as \>=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. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). |
| Primary | Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3 | From Dose 1 to 1 Month after Dose 3 | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure. |
| Primary | Percentage of Participants With AEs From Dose 4 to 1 Month After Dose 4 | From Dose 4 to 1 Month after Dose 4 | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
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 7 Days After Dose 1 | Within 7 Days after Dose 1 | Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received incorrect vaccination was excluded from analysis. Here, Number of Participants Analyzed signifies number of participants with any e-diary data reported after Dose 1. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Local Reactions Within 7 Days After Dose 2 | Within 7 Days after Dose 2 | Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received incorrect vaccination was excluded from analysis. Here, Number of Participants Analyzed signifies number of participants with any e-diary data reported after Dose 2. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Local Reactions Within 7 Days After Dose 3 | Within 7 Days after Dose 3 | Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received incorrect vaccination was excluded from analysis. Here, Number of Participants Analyzed signifies number of participants with any e-diary data reported after Dose 3. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Local Reactions Within 7 Days After Dose 4 | Within 7 Days after Dose 4 | Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received incorrect vaccination was excluded from analysis. Here, Number of Participants Analyzed signifies number of participants with any e-diary data reported after Dose 4. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Within 7 Days after Dose 1 | Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received incorrect vaccination was excluded from analysis. Here, Number of Participants Analyzed signifies number of participants with any e-diary data reported after Dose 1. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Within 7 Days after Dose 2 | Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received incorrect vaccination was excluded from analysis. Here, Number of Participants Analyzed signifies number of participants with any e-diary data reported after Dose 2. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Within 7 Days after Dose 3 | Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received incorrect vaccination was excluded from analysis. Here, Number of Participants Analyzed signifies number of participants with any e-diary data reported after Dose 3. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Systemic Events Within 7 Days After Dose 4 | Within 7 Days after Dose 4 | Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received incorrect vaccination was excluded from analysis. Here, Number of Participants Analyzed signifies number of participants with any e-diary data reported after Dose 4. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3 | From Dose 1 to 1 Month after Dose 3 | Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received incorrect vaccination was excluded from analysis. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With AEs From Dose 4 to 1 Month After Dose 4 | From Dose 4 to 1 Month after Dose 4 | Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received incorrect vaccination was excluded from analysis. Here, Number of Participants Analyzed signifies number of participants who received Dose 4. | Percentage of participants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group184
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 7 Days After Dose 1 | 20vPnC | Redness: Mild | 18.0 | 95% Confidence Interval 15.7 | Percentage of participants |
| Percentage of Participants With Local Reactions Within 7 Days After Dose 1 | 13vPnC | Redness: Mild | 16.5 | 95% Confidence Interval 13.3 | Percentage of participants |
| Percentage of Participants With Local Reactions Within 7 Days After Dose 1 | 20vPnC | Redness: Moderate | 3.7 | 95% Confidence Interval 2.6 | Percentage of participants |
| Percentage of Participants With Local Reactions Within 7 Days After Dose 1 | 13vPnC | Redness: Moderate | 3.0 | 95% Confidence Interval 1.7 | Percentage of participants |
| Percentage of Participants With Local Reactions Within 7 Days After Dose 1 | 20vPnC | Redness: Severe | 0 | 95% Confidence Interval 0.0 | Percentage of participants |
| Percentage of Participants With Local Reactions Within 7 Days After Dose 1 | 13vPnC | Redness: Severe | 0 | 95% Confidence Interval 0.0 | Percentage of participants |
| Percentage of Participants With Local Reactions Within 7 Days After Dose 1 | 20vPnC | Swelling: Mild | 13.8 | 95% Confidence Interval 11.7 | Percentage of participants |
| Percentage of Participants With Local Reactions Within 7 Days After Dose 1 | 13vPnC | Swelling: Mild | 11.2 | 95% Confidence Interval 8.6 | Percentage of participants |
| Percentage of Participants With Local Reactions Within 7 Days After Dose 1 | 20vPnC | Swelling: Moderate | 6.1 | 95% Confidence Interval 4.7 | Percentage of participants |
| Percentage of Participants With Local Reactions Within 7 Days After Dose 1 | 13vPnC | Swelling: Moderate | 5.4 | 95% Confidence Interval 3.6 | Percentage of participants |
1 to 10 of 184Source ClinicalTrials.gov
See all 184 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 20vPnC | 1,006 | |
| Overall Study | STARTED | 13vPnC | 505 | |
| Overall Study | Dose 1 | 20vPnC | 1,000 | |
| Overall Study | Dose 1 | 13vPnC | 504 | |
| Overall Study | Dose 2 | 20vPnC | 972 | |
| Overall Study | Dose 2 | 13vPnC | 492 | |
| Overall Study | Dose 3 | 20vPnC | 964 | |
| Overall Study | Dose 3 | 13vPnC | 483 | |
| Overall Study | Dose 4 | 20vPnC | 923 | |
| Overall Study | Dose 4 | 13vPnC | 462 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events116
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 | Injection site erythema (REDNESS) | General disorders | 20vPnC | 455 | 1,000 | |
| other | Injection site erythema (REDNESS) | General disorders | 13vPnC | 224 | 503 | |
| other | Injection site pain (PAIN) | General disorders | 20vPnC | 609 | 1,000 | |
| other | Injection site pain (PAIN) | General disorders | 13vPnC | 309 | 503 | |
| other | Injection site swelling (SWELLING) | General disorders | 20vPnC | 372 | 1,000 | |
| other | Injection site swelling (SWELLING) | General disorders | 13vPnC | 176 | 503 | |
| other | Pyrexia (FEVER) | General disorders | 20vPnC | 336 | 1,000 | |
| other | Pyrexia (FEVER) | General disorders | 13vPnC | 159 | 503 | |
| other | Upper respiratory tract infection | Infections and infestations | 20vPnC | 59 | 1,000 | |
| other | Upper respiratory tract infection | Infections and infestations | 13vPnC | 28 | 503 |
1 to 10 of 116Source ClinicalTrials.gov
See all 116 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 20vPnC | 0 | 1,000 |
| Total, all-cause mortality | 13vPnC | 0 | 503 |
| Total, other adverse events | 20vPnC | 960 | 1,000 |
| Total, other adverse events | 13vPnC | 481 | 503 |
| Total, serious adverse events | 20vPnC | 44 | 1,000 |
| Total, serious adverse events | 13vPnC | 28 | 503 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|---|
| 20vPnC vs 13vPnC: deaths from any cause | Trial comparisons |
| 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.
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