Trial · NCT04382326
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants
NCT04382326, Phase 3, Completed, Pfizer; results first posted 2023-12-06
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. 20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants. Trials, record NCT04382326. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04382326
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants
- NCT number
- NCT04382326
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,997 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Pneumococcal Disease
- Interventions
- 20-valent pneumococcal conjugate vaccine, 13-valent pneumococcal conjugate vaccine
- First posted
- 2020-05-11
- Last updated
- 2023-12-06
- Other registries' IDs
- eudract:2019-003305-10
- Results first posted
- 2023-12-06
Source ClinicalTrials.gov
Registered outcomes27
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 were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were graded as mild (0.5 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 example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). |
| Primary | Percentage of Participants With Local Reaction Within 7 Days After Dose 2 | Within 7 Days After Dose 2 | Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were graded as mild (0.5 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 example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). |
| Primary | Percentage of Participants With Local Reactions Within 7 Days After Dose 3 | Within 7 days after Dose 3 | Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were graded as mild (0.5 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 example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). |
| Primary | Percentage of Participants With Local Reactions Within 7 Days After Dose 4 | Within 7 days after Dose 4 | Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were graded as mild (0.5 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 example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). 95 percent (%) confidence interval (CI) was based on Clopper and Pearson method. |
| 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/increased sleep and irritability, recorded by parents/legal guardians of participant's using an e-diary. 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). 95% CI was based on Clopper and Pearson method. |
| 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/increased sleep and irritability, recorded by parents/legal guardians of participant's using an e-diary. 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). 95% CI was based on Clopper and Pearson method. |
| 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/increased sleep and irritability, recorded by parents/legal guardians of participant's using an e-diary. 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). 95% CI was based on Clopper and Pearson method. |
| 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/increased sleep and irritability, recorded by parents/legal guardians of participant's using an e-diary. 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). 95% CI was based on Clopper and Pearson method. |
| 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 participants, temporally associated with the use of study treatment, whether or not considered related to the study treatment. 95% CI was based on the Clopper and Pearson method. AEs reported in this outcome measure excluded local reactions and systemic events. |
| 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 treatment, whether or not considered related to the study treatment. 95% CI was based on the Clopper and Pearson method. AEs reported in this outcome measure excluded local reactions and systemic events. |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 registered outcomesOutcomes27
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 the participants who received at least 1 dose of the investigational product (IP) with safety follow up after any dose. 'Number of Participants Analyzed' = number of participants with any electronic diary (e-diary) data reported after Dose 1. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Local Reaction Within 7 Days After Dose 2 | Within 7 Days After Dose 2 | Safety population included all the participants who received at least 1 dose of the investigational product (IP) with safety follow up after any dose. 'Number of Participants Analyzed' = number of participants with any electronic diary (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 the participants who received at least 1 dose of the investigational product (IP) with safety follow up after any dose. 'Number of Participants Analyzed' = number of participants with any electronic diary (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 the participants who received at least 1 dose of the investigational product (IP) with safety follow up after any dose. Here, 'Number of Participants Analyzed' = number of participants with any electronic diary (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 the participants who received at least 1 dose of the IP with safety follow up after any dose. 'Number of Participants Analyzed' = 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 the participants who received at least 1 dose of the IP with safety follow up after any dose. 'Number of Participants Analyzed' = 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 the participants who received at least 1 dose of the IP with safety follow up after any dose. 'Number of Participants Analyzed' = 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 the participants who received at least 1 dose of the IP with safety follow up after any dose. 'Number of Participants Analyzed' = 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 the participants who received at least 1 dose of the IP with safety follow up after any dose. Here, 'Number of Participants Analyzed' = number of participants who received Dose 1. | 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 the participants who received at least 1 dose of the IP with safety follow up after any dose. Here, 'Number of Participants Analyzed' = number of participants who received Dose 4 and had safety follow up after Dose 4. | Percentage of participants | NUMBER |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 outcomesResults by group638
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: Any | 25.5 | 95% Confidence Interval 22.8 to 28.3 | Percentage of participants |
| Percentage of Participants With Local Reactions Within 7 Days After Dose 1 | 13vPnC | Redness: Any | 24.6 | 95% Confidence Interval 22.0 to 27.5 | Percentage of participants |
| Percentage of Participants With Local Reactions Within 7 Days After Dose 1 | 20vPnC | Redness: Mild | 21.5 | 95% Confidence Interval 18.9 to 24.1 | Percentage of participants |
| Percentage of Participants With Local Reactions Within 7 Days After Dose 1 | 13vPnC | Redness: Mild | 22.3 | 95% Confidence Interval 19.7 to 25.0 | Percentage of participants |
| Percentage of Participants With Local Reactions Within 7 Days After Dose 1 | 20vPnC | Redness: Moderate | 4.0 | 95% Confidence Interval 2.9 to 5.4 | Percentage of participants |
| Percentage of Participants With Local Reactions Within 7 Days After Dose 1 | 13vPnC | Redness: Moderate | 2.4 | 95% Confidence Interval 1.5 to 3.5 | Percentage of participants |
| Percentage of Participants With Local Reactions Within 7 Days After Dose 1 | 20vPnC | Redness: Severe | 0 | 95% Confidence Interval 0.0 to 0.4 | Percentage of participants |
| Percentage of Participants With Local Reactions Within 7 Days After Dose 1 | 13vPnC | Redness: Severe | 0 | 95% Confidence Interval 0.0 to 0.4 | Percentage of participants |
| Percentage of Participants With Local Reactions Within 7 Days After Dose 1 | 20vPnC | Swelling: Any | 16.4 | 95% Confidence Interval 14.2 to 18.9 | Percentage of participants |
| Percentage of Participants With Local Reactions Within 7 Days After Dose 1 | 13vPnC | Swelling: Any | 18.8 | 95% Confidence Interval 16.4 to 21.4 | Percentage of participants |
1 to 10 of 638Source ClinicalTrials.gov
See all 638 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 20vPnC | 1,001 | |
| Overall Study | STARTED | 13vPnC | 987 | |
| Overall Study | COMPLETED | 20vPnC | 821 | |
| Overall Study | COMPLETED | 13vPnC | 799 | |
| Overall Study | NOT COMPLETED | 20vPnC | 180 | |
| Overall Study | NOT COMPLETED | 13vPnC | 188 |
Source ClinicalTrials.gov
Adverse events114
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 | 498 | 1,001 | 944 |
| other | Injection site erythema (REDNESS) | General disorders | 13vPnC | 492 | 987 | 986 |
| other | Injection site pain (PAIN) | General disorders | 20vPnC | 689 | 1,001 | 1,634 |
| other | Injection site pain (PAIN) | General disorders | 13vPnC | 663 | 987 | 1,543 |
| other | Injection site swelling (SWELLING) | General disorders | 20vPnC | 353 | 1,001 | 635 |
| other | Injection site swelling (SWELLING) | General disorders | 13vPnC | 359 | 987 | 707 |
| other | Pyrexia (FEVER) | General disorders | 20vPnC | 322 | 1,001 | 550 |
| other | Pyrexia (FEVER) | General disorders | 13vPnC | 314 | 987 | 504 |
| other | Otitis media | Infections and infestations | 20vPnC | 56 | 1,001 | 73 |
| other | Otitis media | Infections and infestations | 13vPnC | 50 | 987 | 65 |
1 to 10 of 114Source ClinicalTrials.gov
See all 114 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 20vPnC | 0 | 1,001 |
| Total, all-cause mortality | 13vPnC | 0 | 987 |
| Total, other adverse events | 20vPnC | 966 | 1,001 |
| Total, other adverse events | 13vPnC | 939 | 987 |
| Total, serious adverse events | 20vPnC | 45 | 1,001 |
| Total, serious adverse events | 13vPnC | 31 | 987 |
Source ClinicalTrials.gov
Papers3
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 |
|---|---|
| 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.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04382326
GET https://conductscience.org/api/trials/v1/NCT04382326/registered?page=2