An Active Safety Surveillance Study for Prevenar 13® Among Chinese Children

Study summary

No information provided.

Study identification

• EU PAS number:
  EUPAS1000000617
• Study ID:
  1000000617
• Official title and acronym:
  An Active Safety Surveillance Study for Prevenar 13® Among Chinese Children
• DARWIN EU® study:
  No
• Study countries:
  China
• Study description:
  This is a non-interventional safety active surveillance study using a population-based electronic health record (EHR) database. The observational, uncontrolled, descriptive study design will be implemented to estimate the incidence of seizures (including febrile seizures), urticaria, angioedema, fever, thrombocytopenic purpura (TP), immune thrombocytopenia (ITP), Henoch-Schonlein purpura (HSP), anaphylaxis/anaphylactic reaction, laryngeal oedema, and Arthus reaction in the predefined risk interval for each outcome. The study period of EHR data reviewed will depend on data availability in the selected EHR databases, which could satisfy the sample size estimated for this study.
• Study status:
  Planned

Study timelines

Date when funding contract was signed

Planned:30/09/2026

Study start date

Planned:31/12/2026

Date of final study report

Planned:31/10/2027

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable