NCT03656939 is a clinical trial in Seizures, sponsored by Pfizer.

Who is sponsoring NCT03656939?

NCT03656939 is sponsored by Pfizer.

What condition does NCT03656939 study?

NCT03656939 studies Seizures, Urticaria and Angioedema, Apnea, Fever.

Is NCT03656939 still recruiting?

NCT03656939 is currently completed. Last updated 27 August 2021.

Are results published for NCT03656939?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-08-27 · How we verify

NCT03656939

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Safety Study For Prevenar 13 Among Chinese Children

Completed Results posted Last updated 27 August 2021

What this trial tests

trial in Seizures in 21,240 participants. Completed in 31 July 2020.

Timeline

1 August 2018

Primary endpoint
31 July 2020

31 July 2020

Quick facts

Lead sponsor	Pfizer
Status	Completed
Study type	OBSERVATIONAL
Enrollment	21,240
Start date	1 August 2018
Primary completion	31 July 2020
Estimated completion	31 July 2020
Sites	1 location across China

Conditions studied

Seizures — all drugs for Seizures →
Urticaria and Angioedema — all drugs for Urticaria and Angioedema →
Apnea — all drugs for Apnea →
Fever — all drugs for Fever →

Sponsor

Pfizer — full company profile →

Who can join

Adults 1 Month to 24 Months, any sex, with Seizures or Urticaria and Angioedema. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 1 Primary · 0 to 3 days after Dose 1

Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.

Group	Value	95% CI
Prevenar 13: Main Study Cohort	NA	NA – NA
Prevenar 13 Cohort: Prospective Cohort Study	NA	NA – NA

Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 1 Primary · 4 to 7 days after Dose 1

Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

Group	Value	95% CI
Prevenar 13: Main Study Cohort	0.025	0.006 – 0.098
Prevenar 13 Cohort: Prospective Cohort Study	NA	NA – NA

Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 1 Primary · 0 to 7 days after Dose 1

Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

Group	Value	95% CI
Prevenar 13: Main Study Cohort	0.012	0.003 – 0.049
Prevenar 13 Cohort: Prospective Cohort Study	NA	NA – NA

Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 1 Primary · 0 to 3 days after Dose 1

Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.

Group	Value	95% CI
Prevenar 13: Main Study Cohort	NA	NA – NA
Prevenar 13 Cohort: Prospective Cohort Study	NA	NA – NA

Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 1 Primary · 4 to 7 days after Dose 1

Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

Group	Value	95% CI
Prevenar 13: Main Study Cohort	0.012	0.002 – 0.087
Prevenar 13 Cohort: Prospective Cohort Study	NA	NA – NA

Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 1 Primary · 0 to 7 days after Dose 1

Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

Group	Value	95% CI
Prevenar 13: Main Study Cohort	0.006	0.001 – 0.044
Prevenar 13 Cohort: Prospective Cohort Study	NA	NA – NA

Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 1 Primary · 0 to 3 days after Dose 1

Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

Urticaria

Group	Value	95% CI
Prevenar 13: Main Study Cohort	0.012	0.002 – 0.087
Prevenar 13 Cohort: Prospective Cohort Study	0.326	0.105 – 1.011

Angioedema

Group	Value	95% CI
Prevenar 13: Main Study Cohort	NA	NA – NA
Prevenar 13 Cohort: Prospective Cohort Study	NA	NA – NA

Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 1 Primary · 4 to 7 days after Dose 1

Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

Urticaria

Group	Value	95% CI
Prevenar 13: Main Study Cohort	0.025	0.006 – 0.098
Prevenar 13 Cohort: Prospective Cohort Study	NA	NA – NA

Angioedema

Group	Value	95% CI
Prevenar 13: Main Study Cohort	NA	NA – NA
Prevenar 13 Cohort: Prospective Cohort Study	NA	NA – NA

Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 1 Primary · 0 to 7 days after Dose 1

Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

Urticaria

Group	Value	95% CI
Prevenar 13: Main Study Cohort	0.019	0.006 – 0.057
Prevenar 13 Cohort: Prospective Cohort Study	0.163	0.053 – 0.506

Angioedema

Group	Value	95% CI
Prevenar 13: Main Study Cohort	NA	NA – NA
Prevenar 13 Cohort: Prospective Cohort Study	NA	NA – NA

Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 1 Primary · 0 to 3 days after Dose 1

Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.

Group	Value	95% CI
Prevenar 13: Main Study Cohort	NA	NA – NA
Prevenar 13 Cohort: Prospective Cohort Study	NA	NA – NA

Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 1 Primary · 4 to 7 days after Dose 1

Incidence rate was calculated as the number of apnea events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.

Group	Value	95% CI
Prevenar 13: Main Study Cohort	NA	NA – NA
Prevenar 13 Cohort: Prospective Cohort Study	NA	NA – NA

Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After Dose 1 Primary · 0 to 7 days after Dose 1

Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.

Group	Value	95% CI
Prevenar 13: Main Study Cohort	NA	NA – NA
Prevenar 13 Cohort: Prospective Cohort Study	NA	NA – NA

Sponsor's own description

This is an observational study based on a population-based EHR database.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03656939 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 27 August 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03656939.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT03656939

Quick facts

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Seizures

Other Pfizer trials

Verify against primary sources