At a glance
ClinicalIndex Comparison Record- ✓Healthy infant aged 6 through 12 weeks
- ✕History of congenital abdominal disorders, intussusception, or abdominal surgery
- ✕Known or suspected impairment of immunological function
- ✕Known hypersensitivity to any component of the rotavirus vaccine or INFANRIX Hexa
- ✕Prior administration of any rotavirus vaccine or oral polio vaccine
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Immunogenicity of Concomitant Use of V260 and INFANRIX™ Hexa in Healthy Infants
In Brief
A Phase 3 clinical trial evaluating Rotavirus Vaccine, Live, Oral, Pentavalent, Comparator: placebo, and 1 other intervention for Rotavirus Disease. Completed, enrolled 403 participants.
Detailed Summary
The study is being conducted to demonstrate that the vaccine to prevent gastroenteritis due to rotavirus may be administered concomitantly with INFANRIX(tm)hexa without impairing the safety and immunogenicity of either vaccine.
Study Details
Timeline
Interventions
3 doses of rotavirus vaccine live, oral, pentavalent on Day 1, 28 to 42 days post dose 1 and 28 to 42 days post dose 2
3 doses of placebo to rotavirus vaccine live, oral, pentavalent on Day 1, 28 to 42 days post dose 1 and 28 to 42 days post dose 2
3 doses of oral Infanrix(tm) Hexa on Day 1, 28 to 42 days post dose 1 and 28 to 42 days post dose 2