Phase 4
N=220
The Effects of Increased Inoculum on Oral Rotavirus Vaccine Take and Immunogenicity
Rotavirus Infection · Vaccine Response Impaired · Vaccine Virus Shedding
Bottom Line
View on ClinicalTrials.gov: NCT02992197 ↗Enrolled (actual)
220
Serious AEs
2.7%
Results posted
Jul 2020
Primary outcome: Primary: Number (or Percentage) of Infants in Each Study Arm Who Test Positive for Fecal Rotavirus Vaccine-strain Virus Shedding Post-vaccination — 63; 55 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Rotarix, dose 1 (Biological); Rotarix, dose 2 (Biological); Placebo (for Rotarix dose 2) (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- University of Vermont
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number (or Percentage) of Infants in Each Study Arm Who Test Positive for Fecal Rotavirus Vaccine-strain Virus Shedding Post-vaccination |
63; 55 | — |
| PRIMARY Number (or Percentage) of Infants in Each Study Arm With Rotavirus-specific Plasma Immunoglobulin A (IgA) Seroconversion Post-vaccination |
41; 42 | — |
| PRIMARY Number (or Percentage) of Infants in Each Study Arm With Successful Vaccine Take, Defined as Positive Fecal Vaccine Shedding Post-vaccination OR Rotavirus-specific Plasma IgA Seroconversion Post-vaccination |
69; 62 | — |
Summary
Rotavirus is the leading cause of diarrhea in children worldwide. Oral rotavirus vaccines work remarkably well in high-income countries, but for unclear reasons they underperform in low-income countries. A double-blind, randomized control trial will be performed to evaluate whether using a higher dose of a currently licensed vaccine (Rotarix, GlaxoSmithKline) can improve immune responses among infants in Dhaka, Bangladesh.
Infants will be randomized 1:1 to receive either a standard or a double dose of Rotarix at 6 and 10 weeks of life. Infants will be assessed for fecal vaccine shedding and serum rotavirus-specific IgA responses to determine vaccine immunogenicity.
Eligibility Criteria
Inclusion Criteria
- Generally healthy infant (as determined by medical officers)
- Age 0-7 days at enrolment
- Mother willing and able to provide signed informed consent
- Mother willing to allow infant to be vaccinated according to study schedule
- Mother willing to allow biological specimens, including blood, stool, and saliva, to be collected from infant according to study protocol
- Mother willing and able to adhere to study schedule
Exclusion Criteria
- Obvious congenital malformation
- Birth weight (if known) or enrolment weight (if birth weight unknown) < 2000 gm
- Known immunocompromising condition in infant
- Enrolment in other vaccine research trials
- Other household member enrolled in this study
Data sourced from ClinicalTrials.gov (NCT02992197). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.