Zinc and/or Probiotic Supplementation of Rotavirus and Oral Polio Virus Vaccines

PHASE4CompletedINTERVENTIONAL
Enrollment

620

Participants

Timeline

Start Date

July 31, 2012

Primary Completion Date

July 31, 2013

Study Completion Date

July 31, 2013

Conditions
Immunity to Oral Rotavirus VaccineImmunity to Oral Polio VaccineShedding of Oral Rotavirus Vaccine
Interventions
DIETARY_SUPPLEMENT

Probiotic

A capsule that contains at least 1 x 10\^9 Lactobacillus rhamnosus GG organisms per capsule. The contents of this capsule were given once daily orally.

DIETARY_SUPPLEMENT

Zinc

Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.

DIETARY_SUPPLEMENT

Probiotic placebo

The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no Lactobacillus rhamnosus GG. The contents of the capsule were given once daily orally.

DIETARY_SUPPLEMENT

Zinc placebo

The zinc placebo excluded the zinc sulphate but contained lactose and was diluted to match the taste. 5 ml of this suspension was given orally once daily.

BIOLOGICAL

Rotavirus vaccine

1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.

BIOLOGICAL

Oral polio vaccine

A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.

Trial Locations (1)

632 004

Christian Medical Center, Vellore, Vellore

All Listed Sponsors
collaborator

Christian Medical College, Vellore, India

OTHER

collaborator

Ministry of Science and Technology, India

OTHER_GOV

lead

PATH

OTHER

NCT01616693 - Zinc and/or Probiotic Supplementation of Rotavirus and Oral Polio Virus Vaccines | Biotech Hunter | Biotech Hunter