Phase 4
N=620
Zinc and/or Probiotic Supplementation of Rotavirus and Oral Polio Virus Vaccines
Immunity to Oral Rotavirus Vaccine · Immunity to Oral Polio Vaccine · Shedding of Oral Rotavirus Vaccine
Bottom Line
View on ClinicalTrials.gov: NCT01616693 ↗Enrolled (actual)
620
Serious AEs
2.3%
Results posted
Nov 2018
Primary outcome: Primary: Number/Percentage of Subjects With Immune Response to Rotavirus Vaccine — 54; 40; 42; 37 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Probiotic (Dietary_supplement); Zinc (Dietary_supplement); Probiotic placebo (Dietary_supplement); Zinc placebo (Dietary_supplement); Rotavirus vaccine (Biological); Oral polio vaccine (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- PATH
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number/Percentage of Subjects With Immune Response to Rotavirus Vaccine |
54; 40; 42; 37; 94; 79 | — |
| PRIMARY Geometric Mean Concentration of Rotavirus-specific IgA |
9.3; 10.8; 11.3; 12.2; 10.0; 11.7 | — |
| SECONDARY Number/Percentage of Subjects With Immune Response to Trivalent Oral Poliovirus Vaccine (OPV) |
120; 129; 117; 121; 249; 238 | — |
| SECONDARY Number/Percentage of Subjects Exhibiting Rotavirus Shedding in Stool After Dose 1 |
1; 1; 1; 2; 2; 3 | — |
| SECONDARY Number/Percentage of Subjects Exhibiting Rotavirus Shedding in Stool After Dose 2 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Serious Adverse Events (SAEs) |
5; 3; 2; 4; 0; 0 | — |
Summary
Background: Strategies are needed to improve oral rotavirus vaccine (RV), which provides suboptimal protection in developing countries. Probiotics and zinc supplementation could improve RV immunogenicity by altering the intestinal microbiota and immune function.
This study enrolled infants 5 weeks old living in urban Vellore, India to assess the effects of daily zinc (5 mg), probiotic (1010 Lactobacillus rhamnosus GG) or placebo on the immunogenicity of two doses of RV (Rotarix,GlaxoSmithKline Biologicals) given at 6 and 10 weeks of age. Probiotics and zinc (or placebo) were provided for six weeks. A single dose of test product was administered daily one week prior to first study dose of rotavirus and polio vaccines through 1 week following second study dose of rotavirus and polio vaccines.
Eligibility Criteria
Inclusion Criteria
- Infants 35-41 days old
- Live in area under surveillance
- Current weight ≥3.2 kg
- No syndromic evidence of immunocompromise as determined by medical doctor
- No prior illness requiring hospitalization
- No current medical condition as determined by medical doctor which precludes study involvement
- Available for follow up for duration of study (through approximately 14 weeks of age)
- Parents/guardians of infant are able to understand and follow study procedures and agree to participate in the study by providing signed informed consent
Exclusion Criteria
- Child has history of atopic symptoms
- Child has a known digestive system defect
- Child has history of chronic diarrhea
- Child has major congenital anomalies
- Child has received a prior dose of rotavirus vaccine
- Child has received a prior dose of polio vaccine (beyond the birth dose)
Data sourced from ClinicalTrials.gov (NCT01616693). 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.