A Study of the Effectiveness and Safety of a New Formulation of RotaTeq™ in Routine Use in a Developing World Setting

Study identification

• EU PAS number:
  EUPAS8342
• Study ID:
  47461
• Official title and acronym:
  A Study of the Effectiveness and Safety of a New Formulation of RotaTeq™ in Routine Use in a Developing World Setting
• DARWIN EU® study:
  No
• Study countries:
  Mali
• Study description:
  This non-interventional study is to monitor the effectiveness and safety of a new enhanced thermostable Vaccine Vial Monitor-Compatible (VVMC) formulation of Rotavirus Vaccine, Live, Oral (RotaTeq) in children aged <5 years in routine conditions of use in public health practice in Mali, Africa. The study will descriptively compare rates of rotavirus moderate-to-severe diarrhea (MSD) and bowel intussusception among children vaccinated with the current formulation of RotaTeq to that of children vaccinated with the new VVMC formulation of RotaTeq (once it is available).
• Study status:
  Finalised

Research institutions and networks

Institutions

Merck Sharp & Dohme LLC

United States

Study timelines

Date when funding contract was signed

Actual:20/10/2014

Study start date

Planned:11/05/2015

Actual:06/05/2015

Data analysis start date

Planned:31/01/2018

Actual:31/01/2018

Date of final study report

Planned:04/09/2018

Actual:14/09/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck Sharpe & Dohme LLC

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only