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

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Prospective, pre-post surveillance study

Study drug and medical condition

• Medical condition to be studied:
  Rotavirus infection

Population studied

• Short description of the study population:
  Approximately 32,000 children under five years of age reside in the demographic surveillance system (DSS) catchment areas of Bamako.; To be eligible for inclusion in the Moderate-to-Severe Diarrhea (MSD) surveillance study, subjects must meet the following inclusion criteria:; 1) Less than five years of age at the time of the study visit; 2) Parent(s)/Guardians(s) provide written informed consent for her/her child to participate in the study; 3) Belongs to the DSS; 4) Seeking care at a Sentinel Health Center (SHC) for diarrhea (three or more loose stools with the previous 24 hours) that has the following characteristics:; • New (onset after seven or more days diarrhea-free); • Acute (onset in the previous seven days), and; • Meets at least one of the following criteria for MSD:; i. Sunken eyes (confirmed for the parent/caretaker as more than normal); ii. Loss of skin turgor (abdominal skin pinch with slow (but less than two seconds) or very slow (greater than two seconds) recoil).; iii. Intravenous rehydration recommended; or; iv. Hospitalization recommended; Additionally, subjects enrolled in the MSD study may not meet the following exclusion criteria:; 1) Subject diagnosed with dysentery; 2) Any condition that, in the opinion of the investigator, might interfere with the evaluation of study objectives.; 3) Enrollment in the study in the past 60 days
• Age groups:
  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)
• Estimated number of subjects:
  5000

Study design details

• Main study objective:
  To compare rates of rotavirus MSD and rates of confirmed intussusception among children vaccinated with three doses of the current formulation of RotaTeq to that of children vaccinated with three doses of the new formulation.
• Outcomes:
  1. The rate of diarrhea that is rotavirus-positive occurring 14 or more days after vaccination with the third dose of RotaTeq versus VVMC RotaTeq2. The incidence of intussusception among vaccinated infants with RotaTeq versus VVMC RotaTeq
• Data analysis plan:
  This study will estimate rates of rotavirus MSD and intussusception pre and post the introduction of the VVMC formulation. These analyses are descriptive and do not formally test hypotheses. Descriptive data analysis of the aggregated information will be performed and the results displayed in tabulated form. Descriptive statistics will be used to describe patient demographics and vaccine coverage and displayed in summary tables.