Phase 4
Completed N=456
Evaluation of the Human Rotavirus Vaccine at Varying Schedules and Doses in Rural Ghana
Rotavirus Gastroenteritis
Source: ClinicalTrials.gov NCT01575197 ↗
Enrolled (actual)
456
Serious AEs
1.8%
Results posted
Jun 2015
Primary outcomePrimary: Immunoglobulin A (IgA) Seroconversion: 6 & 10 Week vs. 6, 10, & 14 Week Vaccination Schedules — 28.9; 43.4 percentage of participants — p=0.014
Summary
The purpose of this study is to determine whether giving the Human Rotavirus Vaccine on alternate dosing schedules will enhance the immune response to the vaccine in a low-resource, high-burden country in Africa. Alternate dosing schedules studied include giving the 2-dose vaccine schedule at a slightly older age and giving an additional dose of the vaccine.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Immunoglobulin A (IgA) Seroconversion: 6 & 10 Week vs. 6, 10, & 14 Week Vaccination Schedules |
28.9; 43.4 | 0.014 sig |
| SECONDARY IgA Seroconversion: 6 & 10 Week vs. 10 & 14 Week Vaccination Schedules |
28.9; 37.4 | 0.16 |
| SECONDARY IgA Geometric Mean Titers (GMTs): 6 & 10 Week vs. 6, 10, & 14 Week Vaccination Schedules |
22.5; 32.6 | 0.038 sig |
| SECONDARY IgA GMTs: 6 & 10 Week vs. 10 & 14 Week Vaccination Schedule |
22.1; 26.5 | 0.30 |
| SECONDARY Baseline Immunoglobulin G (IgG) Levels: Impact on IgA Seroconversion Post-vaccination |
— | — |
| SECONDARY Vaccine-type Rotavirus Shedding in Stool |
— | — |
| SECONDARY SAE Assessment |
— | — |
Eligibility Criteria
Inclusion Criteria
- Between 42 and 55 days of age at the time of enrollment.
- Healthy infant free of chronic or serious medical condition as determined by history and physical examination at the time of study enrollment.
- Parents/guardians of each subject are able to understand and follow study procedures and agree to participate in the study by providing parental/guardian permission.
Exclusion Criteria
- If child has previously had intussusception or abdominal surgery.
- Use of any immunosuppressive drugs or immunoglobulin and/or blood product use since birth or anticipated during study period.
- Current enrollment in any other intervention trial or use of any investigational drug or vaccine throughout the study period.
- Birthweight less than 2000 grams or gestation < 36 weeks, if this information is available.
- Any subject who reports plan to leave the study area before the completion of the study (i.e., relocation, migration, etc.).
- Another child living in the same compound is already enrolled in the trial (i.e., only one participant can be enrolled per compound).
- After the rotavirus vaccine is introduced into the routine EPI system in Navrongo: Another child in the compound is less than 16 weeks of age.
- The child has received rotavirus vaccine outside of this study.
Data sourced from ClinicalTrials.gov (NCT01575197). 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. Informational only — not medical advice.