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

This study has been completed.
Sponsor:
Collaborators:
Christian Medical College, Vellore, India
Ministry of Science and Technology, India
Information provided by (Responsible Party):
PATH
ClinicalTrials.gov Identifier:
NCT01616693
First received: June 6, 2012
Last updated: August 28, 2013
Last verified: August 2013

June 6, 2012
August 28, 2013
July 2012
July 2013   (final data collection date for primary outcome measure)
Change in Rotavirus IgA immune response [ Time Frame: Baseline and 4 weeks post rotavirus vaccine dose 2 ] [ Designated as safety issue: No ]
A serologic immune response to rotavirus vaccine will be defined as an increase in serum anti-rotavirus (RV) VP6 IgA antibodies consistent with seroconversion (detection of serum anti-RV VP6 IgA antibodies at a concentration ≥20 U/ml in a previously seronegative individual) or a fourfold rise in anti-RV VP6 IgA antibodies between baseline and 14 weeks of age.
Same as current
Complete list of historical versions of study NCT01616693 on ClinicalTrials.gov Archive Site
  • Change in Polio neutralizing antibody titer immune response [ Time Frame: Baseline and 4 weeks post OPV dose 2 ] [ Designated as safety issue: No ]
    A serologic immune response to oral polio vaccine will be defined as a neutralizing antibody titer to polio virus subtype 3 greater than or equal to 1:8 at 14 weeks of age. This antigen will be used because it is conservative in that it gives the lowest immune response of all three polio antigens.
  • Change in Rotavirus IgA immune response (GMTs) [ Time Frame: Baseline and 4 weeks post rotavirus vaccine dose 2 ] [ Designated as safety issue: No ]
    Geometric mean titers (GMTs) of serum anti-rotavirus VP6 IgA antibody
  • Serious adverse events (SAEs) [ Time Frame: Day 0, vaccine dose 1 to 4 weeks post vaccine dose 2 ] [ Designated as safety issue: Yes ]
    Serious adverse events (SAEs) and solicited adverse events (AEs) will be monitored.
  • Rotavirus vaccine shedding [ Time Frame: 0, 4 and/or 7 day post dose 1 and dose 2 rotavirus vaccine ] [ Designated as safety issue: No ]
    Shedding of rotavirus following vaccination through detection of rotavirus antigen by ELISA and confirmed as vaccine type by RT-PCR.
Same as current
Not Provided
Not Provided
 
Zinc and/or Probiotic Supplementation of Rotavirus and Oral Polio Virus Vaccines
Supplementation With Zinc and/or Probiotics to Enhance the Immune Response of Oral Rotavirus and Polio Vaccines in Indian Infants

The percentage of participants with a serologic immune response (seroconversion or four-fold rise in rotavirus IgA antibodies) to rotavirus vaccine at 14 weeks of age among infants receiving zinc or probiotic supplements will be at least 15% higher and significantly better to that of infants who receive a placebo for zinc or probiotic supplement.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
  • Immunity to Oral Rotavirus Vaccine
  • Immunity to Oral Polio Vaccine
  • Shedding of Oral Rotavirus Vaccine
Biological: Rotavirus vaccine (Rotarix), oral polio vaccine (Bio-polio), zinc supplement and probiotic supplement (Culturelle)

Oral rotavirus vaccine (Rotarix). 2 doses (1 ml) at 6 and 10 weeks of age.

Oral polio vaccine (Bio-polio). 3 doses (0.1 ml) at 6, 10 and 14 weeks of age.

Oral zinc sulphate syrup or placebo (1mg/ml; 5ml), given weekly starting 1 week pre-rotavirus vaccine dose 1 through 1 week post rotavirus vaccine dose 2.

Oral probiotic, Lactobacillus rhamnosus (Culturelle) or placebo (lx10^9; 20ml), given weekly starting 1 week pre-rotavirus vaccine dose 1 through 1 week post rotavirus vaccine dose 2.

  • Experimental: Zinc and probiotic
    Receives both zinc and probiotic supplements along with rotavirus and oral polio vaccines
    Intervention: Biological: Rotavirus vaccine (Rotarix), oral polio vaccine (Bio-polio), zinc supplement and probiotic supplement (Culturelle)
  • Active Comparator: Zinc and probiotic placebo supplements
    Receives zinc and probiotic placebo supplements along with rotavirus and oral polio vaccines
    Intervention: Biological: Rotavirus vaccine (Rotarix), oral polio vaccine (Bio-polio), zinc supplement and probiotic supplement (Culturelle)
  • Active Comparator: Zinc placebo and probiotic supplements
    Receives zinc placebo and probiotic supplements along with rotavirus and oral polio vaccines
    Intervention: Biological: Rotavirus vaccine (Rotarix), oral polio vaccine (Bio-polio), zinc supplement and probiotic supplement (Culturelle)
  • Placebo Comparator: Zinc placebo and probiotic placebo
    Receives zinc placebo and probiotic placebo along with rotavirus and oral polio vaccines
    Intervention: Biological: Rotavirus vaccine (Rotarix), oral polio vaccine (Bio-polio), zinc supplement and probiotic supplement (Culturelle)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
620
July 2013
July 2013   (final data collection date for primary outcome measure)

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)
Both
5 Weeks to 16 Weeks
Yes
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01616693
CMC ZP 2012; PATH HS-658
Yes
PATH
PATH
  • Christian Medical College, Vellore, India
  • Ministry of Science and Technology, India
Principal Investigator: Gagandeep Kang, MD, PhD, FRCPath, FAAM, FASc Christian Medical Center, Vellore, India
PATH
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP