Trial Outcomes & Findings for Zinc and/or Probiotic Supplementation of Rotavirus and Oral Polio Virus Vaccines (NCT NCT01616693)
NCT ID: NCT01616693
Last Updated: 2018-12-26
Results Overview
Defined as an increase in serum anti-rotavirus (RV) VP6 IgA antibodies consistent with seroconversion (detection of serum anti-RV VP6 immunoglobulin A (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. Pre-vaccination blood samples were taken when the subject received the first dose of rotavirus vaccine (when the subject was 6 weeks of age); post-vaccination blood samples were taken 4 weeks after the second dose of rotavirus vaccine was administered (14 weeks of age).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
620 participants
Primary outcome timeframe
from first dose of rotavirus vaccine to 4 weeks after last dose of vaccine
Results posted on
2018-12-26
Participant Flow
Potential participants for this study lived in the area surrounding the Christian Medical College (CMC) in the town of Vellore, Tamil Nadu, India. Parents were contacted through the existing Demographic Surveillance System shortly after the child's birth. Procedures were conducted in the Chinallapuram Field Clinic.
Participant milestones
| Measure |
Zinc and Probiotic
Received daily zinc and probiotic supplements, in addition to rotavirus vaccine and trivalent oral polio vaccines.
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.
Zinc: Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.
Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
|
Zinc Alone
Received daily zinc and probiotic placebo supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.
Zinc: Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.
Probiotic placebo: The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no LGG. The contents of the capsule were given once daily orally.
Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
|
Probiotic Alone
Received daily zinc placebo and probiotic supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.
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.
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.
Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
|
Placebo
Received daily zinc placebo and probiotic supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.
Probiotic placebo: The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no LGG. The contents of the capsule were given once daily orally.
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.
Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
|
|---|---|---|---|---|
|
Evaluated for Safety
STARTED
|
155
|
155
|
155
|
155
|
|
Evaluated for Safety
COMPLETED
|
154
|
155
|
154
|
155
|
|
Evaluated for Safety
NOT COMPLETED
|
1
|
0
|
1
|
0
|
|
Received Both Vaccines
STARTED
|
154
|
155
|
154
|
155
|
|
Received Both Vaccines
COMPLETED
|
141
|
145
|
142
|
136
|
|
Received Both Vaccines
NOT COMPLETED
|
13
|
10
|
12
|
19
|
|
Blood Analyzed for Immunogenicity
STARTED
|
141
|
145
|
142
|
136
|
|
Blood Analyzed for Immunogenicity
COMPLETED
|
137
|
143
|
136
|
135
|
|
Blood Analyzed for Immunogenicity
NOT COMPLETED
|
4
|
2
|
6
|
1
|
Reasons for withdrawal
| Measure |
Zinc and Probiotic
Received daily zinc and probiotic supplements, in addition to rotavirus vaccine and trivalent oral polio vaccines.
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.
Zinc: Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.
Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
|
Zinc Alone
Received daily zinc and probiotic placebo supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.
Zinc: Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.
Probiotic placebo: The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no LGG. The contents of the capsule were given once daily orally.
Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
|
Probiotic Alone
Received daily zinc placebo and probiotic supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.
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.
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.
Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
|
Placebo
Received daily zinc placebo and probiotic supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.
Probiotic placebo: The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no LGG. The contents of the capsule were given once daily orally.
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.
Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
|
|---|---|---|---|---|
|
Evaluated for Safety
Physician Decision
|
1
|
0
|
1
|
0
|
|
Received Both Vaccines
Adverse Event
|
2
|
0
|
0
|
0
|
|
Received Both Vaccines
Withdrawal by Subject
|
7
|
7
|
8
|
15
|
|
Received Both Vaccines
Lost to Follow-up
|
4
|
3
|
4
|
4
|
|
Blood Analyzed for Immunogenicity
Protocol Violation
|
4
|
2
|
6
|
1
|
Baseline Characteristics
Zinc and/or Probiotic Supplementation of Rotavirus and Oral Polio Virus Vaccines
Baseline characteristics by cohort
| Measure |
Zinc and Probiotic
n=155 Participants
Received daily zinc and probiotic supplements, in addition to rotavirus vaccine and trivalent oral polio vaccines.
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.
Zinc: Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.
Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
|
Zinc Alone
n=155 Participants
Received daily zinc and probiotic placebo supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.
Zinc: Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.
Probiotic placebo: The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no LGG. The contents of the capsule were given once daily orally.
Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
|
Probiotic Alone
n=155 Participants
Received daily zinc placebo and probiotic supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.
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.
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.
Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
|
Placebo
n=155 Participants
Received daily zinc placebo and probiotic supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.
Probiotic placebo: The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no LGG. The contents of the capsule were given once daily orally.
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.
Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
|
Total
n=620 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
5.1 weeks
STANDARD_DEVIATION .3 • n=5 Participants
|
5.1 weeks
STANDARD_DEVIATION .3 • n=7 Participants
|
5.1 weeks
STANDARD_DEVIATION .3 • n=5 Participants
|
5.2 weeks
STANDARD_DEVIATION .3 • n=4 Participants
|
5.1 weeks
STANDARD_DEVIATION .3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
75 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
84 Participants
n=4 Participants
|
326 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
80 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
294 Participants
n=21 Participants
|
|
Region of Enrollment
India
|
155 participants
n=5 Participants
|
155 participants
n=7 Participants
|
155 participants
n=5 Participants
|
155 participants
n=4 Participants
|
620 participants
n=21 Participants
|
|
Religion
Hindu
|
99 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
104 Participants
n=4 Participants
|
415 Participants
n=21 Participants
|
|
Religion
Christian
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Religion
Muslim
|
51 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
179 Participants
n=21 Participants
|
|
Type of house
Permanent (pucca)
|
85 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
360 Participants
n=21 Participants
|
|
Type of house
Mixed
|
59 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
212 Participants
n=21 Participants
|
|
Type of house
Temporary
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: from first dose of rotavirus vaccine to 4 weeks after last dose of vaccineDefined as an increase in serum anti-rotavirus (RV) VP6 IgA antibodies consistent with seroconversion (detection of serum anti-RV VP6 immunoglobulin A (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. Pre-vaccination blood samples were taken when the subject received the first dose of rotavirus vaccine (when the subject was 6 weeks of age); post-vaccination blood samples were taken 4 weeks after the second dose of rotavirus vaccine was administered (14 weeks of age).
Outcome measures
| Measure |
Zinc and Probiotic
n=137 Participants
Received daily zinc and probiotic supplements, in addition to rotavirus vaccine and trivalent oral polio vaccines.
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.
Zinc: Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.
Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
|
Zinc Alone
n=143 Participants
Received daily zinc and probiotic placebo supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.
Zinc: Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.
Probiotic placebo: The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no LGG. The contents of the capsule were given once daily orally.
Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
|
Probiotic Alone
n=136 Participants
Received daily zinc placebo and probiotic supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.
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.
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.
Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
|
Placebo
n=135 Participants
Received daily zinc placebo and probiotic placebo, in addition to rotavirus vaccine and trivalent oral polio vaccine.
Probiotic placebo: The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no LGG. The contents of the capsule were given once daily orally.
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.
Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
|
Zinc
n=280 Participants
All subjects receiving zinc supplementation (zinc and probiotic; zinc and probiotic placebo groups)
|
No Zinc
n=271 Participants
All subjects receiving zinc placebo (group receiving zinc placebo and probiotic, combined with group receiving zinc placebo and probiotic placebo)
|
Probiotic
n=273 Participants
All subjects receiving probiotic supplementation (zinc and probiotic; zinc placebo and probiotic)
|
No Probiotic
n=278 Participants
All subjects receiving probiotic placebo (zinc and probiotic placebo; zinc placebo and probiotic placebo)
|
|---|---|---|---|---|---|---|---|---|
|
Number/Percentage of Subjects With Immune Response to Rotavirus Vaccine
Seroconversion
|
54 Participants
|
40 Participants
|
42 Participants
|
37 Participants
|
94 Participants
|
79 Participants
|
96 Participants
|
77 Participants
|
|
Number/Percentage of Subjects With Immune Response to Rotavirus Vaccine
No seroconversion
|
83 Participants
|
103 Participants
|
94 Participants
|
98 Participants
|
186 Participants
|
192 Participants
|
177 Participants
|
201 Participants
|
PRIMARY outcome
Timeframe: from first dose of rotavirus vaccine to 4 weeks after last dose of vaccinePre-vaccination blood samples were taken when the subject received the first dose of rotavirus vaccine (when the subject was 6 weeks of age); post-vaccination blood samples were taken 4 weeks after the second dose of rotavirus was administered (14 weeks of age). Pre-vaccination blood samples were taken when the subject received the first dose of rotavirus vaccine (when the subject was 6 weeks of age); post-vaccination blood samples were taken 4 weeks after the second dose of rotavirus vaccine was administered (14 weeks of age).
Outcome measures
| Measure |
Zinc and Probiotic
n=137 Participants
Received daily zinc and probiotic supplements, in addition to rotavirus vaccine and trivalent oral polio vaccines.
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.
Zinc: Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.
Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
|
Zinc Alone
n=143 Participants
Received daily zinc and probiotic placebo supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.
Zinc: Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.
Probiotic placebo: The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no LGG. The contents of the capsule were given once daily orally.
Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
|
Probiotic Alone
n=136 Participants
Received daily zinc placebo and probiotic supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.
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.
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.
Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
|
Placebo
n=135 Participants
Received daily zinc placebo and probiotic placebo, in addition to rotavirus vaccine and trivalent oral polio vaccine.
Probiotic placebo: The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no LGG. The contents of the capsule were given once daily orally.
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.
Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
|
Zinc
n=280 Participants
All subjects receiving zinc supplementation (zinc and probiotic; zinc and probiotic placebo groups)
|
No Zinc
n=271 Participants
All subjects receiving zinc placebo (group receiving zinc placebo and probiotic, combined with group receiving zinc placebo and probiotic placebo)
|
Probiotic
n=273 Participants
All subjects receiving probiotic supplementation (zinc and probiotic; zinc placebo and probiotic)
|
No Probiotic
n=278 Participants
All subjects receiving probiotic placebo (zinc and probiotic placebo; zinc placebo and probiotic placebo)
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Concentration of Rotavirus-specific IgA
Pre-vaccination
|
9.3 titer
Interval 7.5 to 11.6
|
10.8 titer
Interval 8.4 to 13.9
|
11.3 titer
Interval 9.0 to 14.2
|
12.2 titer
Interval 9.5 to 15.7
|
10.0 titer
Interval 8.5 to 11.8
|
11.7 titer
Interval 9.9 to 13.9
|
10.2 titer
Interval 8.7 to 12.0
|
11.5 titer
Interval 9.6 to 13.7
|
|
Geometric Mean Concentration of Rotavirus-specific IgA
Post-vaccination
|
23.4 titer
Interval 17.5 to 31.3
|
23.9 titer
Interval 17.8 to 32.1
|
25.4 titer
Interval 19.2 to 33.6
|
26.0 titer
Interval 19.3 to 34.9
|
23.7 titer
Interval 19.3 to 29.1
|
25.7 titer
Interval 21.0 to 31.4
|
24.4 titer
Interval 19.9 to 29.8
|
24.9 titer
Interval 20.3 to 30.6
|
SECONDARY outcome
Timeframe: from first dose of OPV to 4 weeks after last dose of OPVA serologic immune response to OPV is 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 as a conservative estimate because it gives the lowest immune response of all three polio antigens. Pre-vaccination blood samples were taken when the subject received the first dose of OPV vaccine (when the subject was 6 weeks of age); post-vaccination blood samples were taken 4 weeks after the second dose of OPV was administered (14 weeks of age).
Outcome measures
| Measure |
Zinc and Probiotic
n=137 Participants
Received daily zinc and probiotic supplements, in addition to rotavirus vaccine and trivalent oral polio vaccines.
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.
Zinc: Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.
Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
|
Zinc Alone
n=143 Participants
Received daily zinc and probiotic placebo supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.
Zinc: Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.
Probiotic placebo: The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no LGG. The contents of the capsule were given once daily orally.
Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
|
Probiotic Alone
n=136 Participants
Received daily zinc placebo and probiotic supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.
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.
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.
Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
|
Placebo
n=135 Participants
Received daily zinc placebo and probiotic placebo, in addition to rotavirus vaccine and trivalent oral polio vaccine.
Probiotic placebo: The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no LGG. The contents of the capsule were given once daily orally.
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.
Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
|
Zinc
n=280 Participants
All subjects receiving zinc supplementation (zinc and probiotic; zinc and probiotic placebo groups)
|
No Zinc
n=271 Participants
All subjects receiving zinc placebo (group receiving zinc placebo and probiotic, combined with group receiving zinc placebo and probiotic placebo)
|
Probiotic
n=273 Participants
All subjects receiving probiotic supplementation (zinc and probiotic; zinc placebo and probiotic)
|
No Probiotic
n=278 Participants
All subjects receiving probiotic placebo (zinc and probiotic placebo; zinc placebo and probiotic placebo)
|
|---|---|---|---|---|---|---|---|---|
|
Number/Percentage of Subjects With Immune Response to Trivalent Oral Poliovirus Vaccine (OPV)
Seroconversion
|
120 Participants
|
129 Participants
|
117 Participants
|
121 Participants
|
249 Participants
|
238 Participants
|
237 Participants
|
250 Participants
|
|
Number/Percentage of Subjects With Immune Response to Trivalent Oral Poliovirus Vaccine (OPV)
No seroconversion
|
17 Participants
|
14 Participants
|
19 Participants
|
14 Participants
|
31 Participants
|
33 Participants
|
36 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: 0, 4 and/or 7 day post dose 1 of rotavirus vaccinePopulation: Subjects who received the vaccination on schedule and had valid stool samples on the days of testing.
Shedding of rotavirus following vaccination through detection of rotavirus antigen by ELISA and confirmed as vaccine type by Real-time polymerase chain reaction (RT-PCR). Stool samples were collected on Day 0 (i.e., day of vaccination or -1), Day 4 (±1) and Day 7 (-1 to +2) post vaccination.
Outcome measures
| Measure |
Zinc and Probiotic
n=121 Participants
Received daily zinc and probiotic supplements, in addition to rotavirus vaccine and trivalent oral polio vaccines.
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.
Zinc: Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.
Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
|
Zinc Alone
n=119 Participants
Received daily zinc and probiotic placebo supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.
Zinc: Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.
Probiotic placebo: The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no LGG. The contents of the capsule were given once daily orally.
Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
|
Probiotic Alone
n=114 Participants
Received daily zinc placebo and probiotic supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.
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.
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.
Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
|
Placebo
n=120 Participants
Received daily zinc placebo and probiotic placebo, in addition to rotavirus vaccine and trivalent oral polio vaccine.
Probiotic placebo: The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no LGG. The contents of the capsule were given once daily orally.
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.
Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
|
Zinc
n=240 Participants
All subjects receiving zinc supplementation (zinc and probiotic; zinc and probiotic placebo groups)
|
No Zinc
n=234 Participants
All subjects receiving zinc placebo (group receiving zinc placebo and probiotic, combined with group receiving zinc placebo and probiotic placebo)
|
Probiotic
n=235 Participants
All subjects receiving probiotic supplementation (zinc and probiotic; zinc placebo and probiotic)
|
No Probiotic
n=239 Participants
All subjects receiving probiotic placebo (zinc and probiotic placebo; zinc placebo and probiotic placebo)
|
|---|---|---|---|---|---|---|---|---|
|
Number/Percentage of Subjects Exhibiting Rotavirus Shedding in Stool After Dose 1
Shedding 4 or 7 days post-vaccination
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
|
Number/Percentage of Subjects Exhibiting Rotavirus Shedding in Stool After Dose 1
No shedding 4 or 7 days post-vaccination
|
120 Participants
|
118 Participants
|
113 Participants
|
118 Participants
|
238 Participants
|
231 Participants
|
233 Participants
|
236 Participants
|
SECONDARY outcome
Timeframe: 0, 4 and/or 7 day post dose 2 of rotavirus vaccinePopulation: Subjects who received the vaccination on schedule and had valid stool samples on the days of testing.
Shedding of rotavirus following vaccination through detection of rotavirus antigen by ELISA and confirmed as vaccine type by RT-PCR. Stool samples were collected on Day 0 (i.e., day of vaccination or -1), Day 4 (±1) and Day 7 (-1 to +2) post vaccination.
Outcome measures
| Measure |
Zinc and Probiotic
n=118 Participants
Received daily zinc and probiotic supplements, in addition to rotavirus vaccine and trivalent oral polio vaccines.
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.
Zinc: Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.
Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
|
Zinc Alone
n=118 Participants
Received daily zinc and probiotic placebo supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.
Zinc: Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.
Probiotic placebo: The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no LGG. The contents of the capsule were given once daily orally.
Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
|
Probiotic Alone
n=114 Participants
Received daily zinc placebo and probiotic supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.
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.
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.
Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
|
Placebo
n=118 Participants
Received daily zinc placebo and probiotic placebo, in addition to rotavirus vaccine and trivalent oral polio vaccine.
Probiotic placebo: The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no LGG. The contents of the capsule were given once daily orally.
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.
Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
|
Zinc
n=136 Participants
All subjects receiving zinc supplementation (zinc and probiotic; zinc and probiotic placebo groups)
|
No Zinc
n=132 Participants
All subjects receiving zinc placebo (group receiving zinc placebo and probiotic, combined with group receiving zinc placebo and probiotic placebo)
|
Probiotic
n=132 Participants
All subjects receiving probiotic supplementation (zinc and probiotic; zinc placebo and probiotic)
|
No Probiotic
n=136 Participants
All subjects receiving probiotic placebo (zinc and probiotic placebo; zinc placebo and probiotic placebo)
|
|---|---|---|---|---|---|---|---|---|
|
Number/Percentage of Subjects Exhibiting Rotavirus Shedding in Stool After Dose 2
Shedding 4 or 7 days post-vaccination
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number/Percentage of Subjects Exhibiting Rotavirus Shedding in Stool After Dose 2
No shedding 4 or 7 days post-vaccination
|
118 Participants
|
118 Participants
|
114 Participants
|
118 Participants
|
136 Participants
|
132 Participants
|
132 Participants
|
136 Participants
|
SECONDARY outcome
Timeframe: from first day of study to 4 weeks after last doseField workers documented information on SAEs through the duration of the study during home visits (twice weekly between study clinic visits) or SAEs were documented by study clinicians at the study clinic or hospital. All SAEs occurring at any time during the study were recorded on a SAE Form and were reviewed and evaluated by a study clinician and the local IRB. The relationship of the SAE to study vaccine was evaluated and recorded and reported to the local institutional review board (IRB). All SAEs were followed until satisfactory resolution.
Outcome measures
| Measure |
Zinc and Probiotic
n=154 Participants
Received daily zinc and probiotic supplements, in addition to rotavirus vaccine and trivalent oral polio vaccines.
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.
Zinc: Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.
Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
|
Zinc Alone
n=155 Participants
Received daily zinc and probiotic placebo supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.
Zinc: Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.
Probiotic placebo: The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no LGG. The contents of the capsule were given once daily orally.
Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
|
Probiotic Alone
n=154 Participants
Received daily zinc placebo and probiotic supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.
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.
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.
Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
|
Placebo
n=155 Participants
Received daily zinc placebo and probiotic placebo, in addition to rotavirus vaccine and trivalent oral polio vaccine.
Probiotic placebo: The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no LGG. The contents of the capsule were given once daily orally.
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.
Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
|
Zinc
All subjects receiving zinc supplementation (zinc and probiotic; zinc and probiotic placebo groups)
|
No Zinc
All subjects receiving zinc placebo (group receiving zinc placebo and probiotic, combined with group receiving zinc placebo and probiotic placebo)
|
Probiotic
All subjects receiving probiotic supplementation (zinc and probiotic; zinc placebo and probiotic)
|
No Probiotic
All subjects receiving probiotic placebo (zinc and probiotic placebo; zinc placebo and probiotic placebo)
|
|---|---|---|---|---|---|---|---|---|
|
Serious Adverse Events (SAEs)
Unrelated SAEs
|
5 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Serious Adverse Events (SAEs)
Related SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Serious Adverse Events (SAEs)
No SAEs
|
149 Participants
|
152 Participants
|
152 Participants
|
151 Participants
|
—
|
—
|
—
|
—
|
Adverse Events
Zinc and Probiotic
Serious events: 5 serious events
Other events: 149 other events
Deaths: 0 deaths
Zinc Alone
Serious events: 3 serious events
Other events: 152 other events
Deaths: 0 deaths
Probiotic Alone
Serious events: 2 serious events
Other events: 148 other events
Deaths: 0 deaths
Placebo
Serious events: 4 serious events
Other events: 146 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Zinc and Probiotic
n=154 participants at risk
Received daily zinc and probiotic supplements, in addition to rotavirus vaccine and trivalent oral polio vaccines.
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.
Zinc: Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.
Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
|
Zinc Alone
n=155 participants at risk
Received daily zinc and probiotic placebo supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.
Zinc: Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.
Probiotic placebo: The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no LGG. The contents of the capsule were given once daily orally.
Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
|
Probiotic Alone
n=154 participants at risk
Received daily zinc placebo and probiotic supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.
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.
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.
Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
|
Placebo
n=155 participants at risk
Received daily zinc placebo and probiotic supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.
Probiotic placebo: The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no LGG. The contents of the capsule were given once daily orally.
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.
Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.9%
3/154 • from first day of study to 4 weeks after last dose (11 weeks)
Field workers documented information on severe adverse events (SAEs) through the duration of the study during home visits (twice weekly between study clinic visits) or SAEs were documented by study clinicians at the study clinic or hospital. Adverse events solicited included: diarrhea, vomiting, reported fever, cough, and cold/runny nose. Any other adverse event that was not considered an SAE was documented as "any other illness".
|
1.3%
2/155 • from first day of study to 4 weeks after last dose (11 weeks)
Field workers documented information on severe adverse events (SAEs) through the duration of the study during home visits (twice weekly between study clinic visits) or SAEs were documented by study clinicians at the study clinic or hospital. Adverse events solicited included: diarrhea, vomiting, reported fever, cough, and cold/runny nose. Any other adverse event that was not considered an SAE was documented as "any other illness".
|
0.65%
1/154 • from first day of study to 4 weeks after last dose (11 weeks)
Field workers documented information on severe adverse events (SAEs) through the duration of the study during home visits (twice weekly between study clinic visits) or SAEs were documented by study clinicians at the study clinic or hospital. Adverse events solicited included: diarrhea, vomiting, reported fever, cough, and cold/runny nose. Any other adverse event that was not considered an SAE was documented as "any other illness".
|
1.9%
3/155 • from first day of study to 4 weeks after last dose (11 weeks)
Field workers documented information on severe adverse events (SAEs) through the duration of the study during home visits (twice weekly between study clinic visits) or SAEs were documented by study clinicians at the study clinic or hospital. Adverse events solicited included: diarrhea, vomiting, reported fever, cough, and cold/runny nose. Any other adverse event that was not considered an SAE was documented as "any other illness".
|
|
Nervous system disorders
Meningitis
|
0.00%
0/154 • from first day of study to 4 weeks after last dose (11 weeks)
Field workers documented information on severe adverse events (SAEs) through the duration of the study during home visits (twice weekly between study clinic visits) or SAEs were documented by study clinicians at the study clinic or hospital. Adverse events solicited included: diarrhea, vomiting, reported fever, cough, and cold/runny nose. Any other adverse event that was not considered an SAE was documented as "any other illness".
|
0.65%
1/155 • from first day of study to 4 weeks after last dose (11 weeks)
Field workers documented information on severe adverse events (SAEs) through the duration of the study during home visits (twice weekly between study clinic visits) or SAEs were documented by study clinicians at the study clinic or hospital. Adverse events solicited included: diarrhea, vomiting, reported fever, cough, and cold/runny nose. Any other adverse event that was not considered an SAE was documented as "any other illness".
|
0.65%
1/154 • from first day of study to 4 weeks after last dose (11 weeks)
Field workers documented information on severe adverse events (SAEs) through the duration of the study during home visits (twice weekly between study clinic visits) or SAEs were documented by study clinicians at the study clinic or hospital. Adverse events solicited included: diarrhea, vomiting, reported fever, cough, and cold/runny nose. Any other adverse event that was not considered an SAE was documented as "any other illness".
|
0.65%
1/155 • from first day of study to 4 weeks after last dose (11 weeks)
Field workers documented information on severe adverse events (SAEs) through the duration of the study during home visits (twice weekly between study clinic visits) or SAEs were documented by study clinicians at the study clinic or hospital. Adverse events solicited included: diarrhea, vomiting, reported fever, cough, and cold/runny nose. Any other adverse event that was not considered an SAE was documented as "any other illness".
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiolitis
|
1.3%
2/154 • from first day of study to 4 weeks after last dose (11 weeks)
Field workers documented information on severe adverse events (SAEs) through the duration of the study during home visits (twice weekly between study clinic visits) or SAEs were documented by study clinicians at the study clinic or hospital. Adverse events solicited included: diarrhea, vomiting, reported fever, cough, and cold/runny nose. Any other adverse event that was not considered an SAE was documented as "any other illness".
|
0.00%
0/155 • from first day of study to 4 weeks after last dose (11 weeks)
Field workers documented information on severe adverse events (SAEs) through the duration of the study during home visits (twice weekly between study clinic visits) or SAEs were documented by study clinicians at the study clinic or hospital. Adverse events solicited included: diarrhea, vomiting, reported fever, cough, and cold/runny nose. Any other adverse event that was not considered an SAE was documented as "any other illness".
|
0.65%
1/154 • from first day of study to 4 weeks after last dose (11 weeks)
Field workers documented information on severe adverse events (SAEs) through the duration of the study during home visits (twice weekly between study clinic visits) or SAEs were documented by study clinicians at the study clinic or hospital. Adverse events solicited included: diarrhea, vomiting, reported fever, cough, and cold/runny nose. Any other adverse event that was not considered an SAE was documented as "any other illness".
|
0.65%
1/155 • from first day of study to 4 weeks after last dose (11 weeks)
Field workers documented information on severe adverse events (SAEs) through the duration of the study during home visits (twice weekly between study clinic visits) or SAEs were documented by study clinicians at the study clinic or hospital. Adverse events solicited included: diarrhea, vomiting, reported fever, cough, and cold/runny nose. Any other adverse event that was not considered an SAE was documented as "any other illness".
|
|
General disorders
Acute febrile illness
|
0.65%
1/154 • from first day of study to 4 weeks after last dose (11 weeks)
Field workers documented information on severe adverse events (SAEs) through the duration of the study during home visits (twice weekly between study clinic visits) or SAEs were documented by study clinicians at the study clinic or hospital. Adverse events solicited included: diarrhea, vomiting, reported fever, cough, and cold/runny nose. Any other adverse event that was not considered an SAE was documented as "any other illness".
|
0.00%
0/155 • from first day of study to 4 weeks after last dose (11 weeks)
Field workers documented information on severe adverse events (SAEs) through the duration of the study during home visits (twice weekly between study clinic visits) or SAEs were documented by study clinicians at the study clinic or hospital. Adverse events solicited included: diarrhea, vomiting, reported fever, cough, and cold/runny nose. Any other adverse event that was not considered an SAE was documented as "any other illness".
|
0.00%
0/154 • from first day of study to 4 weeks after last dose (11 weeks)
Field workers documented information on severe adverse events (SAEs) through the duration of the study during home visits (twice weekly between study clinic visits) or SAEs were documented by study clinicians at the study clinic or hospital. Adverse events solicited included: diarrhea, vomiting, reported fever, cough, and cold/runny nose. Any other adverse event that was not considered an SAE was documented as "any other illness".
|
0.00%
0/155 • from first day of study to 4 weeks after last dose (11 weeks)
Field workers documented information on severe adverse events (SAEs) through the duration of the study during home visits (twice weekly between study clinic visits) or SAEs were documented by study clinicians at the study clinic or hospital. Adverse events solicited included: diarrhea, vomiting, reported fever, cough, and cold/runny nose. Any other adverse event that was not considered an SAE was documented as "any other illness".
|
Other adverse events
| Measure |
Zinc and Probiotic
n=154 participants at risk
Received daily zinc and probiotic supplements, in addition to rotavirus vaccine and trivalent oral polio vaccines.
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.
Zinc: Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.
Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
|
Zinc Alone
n=155 participants at risk
Received daily zinc and probiotic placebo supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.
Zinc: Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.
Probiotic placebo: The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no LGG. The contents of the capsule were given once daily orally.
Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
|
Probiotic Alone
n=154 participants at risk
Received daily zinc placebo and probiotic supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.
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.
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.
Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
|
Placebo
n=155 participants at risk
Received daily zinc placebo and probiotic supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.
Probiotic placebo: The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no LGG. The contents of the capsule were given once daily orally.
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.
Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
24.7%
38/154 • from first day of study to 4 weeks after last dose (11 weeks)
Field workers documented information on severe adverse events (SAEs) through the duration of the study during home visits (twice weekly between study clinic visits) or SAEs were documented by study clinicians at the study clinic or hospital. Adverse events solicited included: diarrhea, vomiting, reported fever, cough, and cold/runny nose. Any other adverse event that was not considered an SAE was documented as "any other illness".
|
30.3%
47/155 • from first day of study to 4 weeks after last dose (11 weeks)
Field workers documented information on severe adverse events (SAEs) through the duration of the study during home visits (twice weekly between study clinic visits) or SAEs were documented by study clinicians at the study clinic or hospital. Adverse events solicited included: diarrhea, vomiting, reported fever, cough, and cold/runny nose. Any other adverse event that was not considered an SAE was documented as "any other illness".
|
28.6%
44/154 • from first day of study to 4 weeks after last dose (11 weeks)
Field workers documented information on severe adverse events (SAEs) through the duration of the study during home visits (twice weekly between study clinic visits) or SAEs were documented by study clinicians at the study clinic or hospital. Adverse events solicited included: diarrhea, vomiting, reported fever, cough, and cold/runny nose. Any other adverse event that was not considered an SAE was documented as "any other illness".
|
20.0%
31/155 • from first day of study to 4 weeks after last dose (11 weeks)
Field workers documented information on severe adverse events (SAEs) through the duration of the study during home visits (twice weekly between study clinic visits) or SAEs were documented by study clinicians at the study clinic or hospital. Adverse events solicited included: diarrhea, vomiting, reported fever, cough, and cold/runny nose. Any other adverse event that was not considered an SAE was documented as "any other illness".
|
|
Gastrointestinal disorders
Vomiting
|
18.8%
29/154 • from first day of study to 4 weeks after last dose (11 weeks)
Field workers documented information on severe adverse events (SAEs) through the duration of the study during home visits (twice weekly between study clinic visits) or SAEs were documented by study clinicians at the study clinic or hospital. Adverse events solicited included: diarrhea, vomiting, reported fever, cough, and cold/runny nose. Any other adverse event that was not considered an SAE was documented as "any other illness".
|
18.7%
29/155 • from first day of study to 4 weeks after last dose (11 weeks)
Field workers documented information on severe adverse events (SAEs) through the duration of the study during home visits (twice weekly between study clinic visits) or SAEs were documented by study clinicians at the study clinic or hospital. Adverse events solicited included: diarrhea, vomiting, reported fever, cough, and cold/runny nose. Any other adverse event that was not considered an SAE was documented as "any other illness".
|
20.8%
32/154 • from first day of study to 4 weeks after last dose (11 weeks)
Field workers documented information on severe adverse events (SAEs) through the duration of the study during home visits (twice weekly between study clinic visits) or SAEs were documented by study clinicians at the study clinic or hospital. Adverse events solicited included: diarrhea, vomiting, reported fever, cough, and cold/runny nose. Any other adverse event that was not considered an SAE was documented as "any other illness".
|
21.3%
33/155 • from first day of study to 4 weeks after last dose (11 weeks)
Field workers documented information on severe adverse events (SAEs) through the duration of the study during home visits (twice weekly between study clinic visits) or SAEs were documented by study clinicians at the study clinic or hospital. Adverse events solicited included: diarrhea, vomiting, reported fever, cough, and cold/runny nose. Any other adverse event that was not considered an SAE was documented as "any other illness".
|
|
General disorders
Fever
|
72.7%
112/154 • from first day of study to 4 weeks after last dose (11 weeks)
Field workers documented information on severe adverse events (SAEs) through the duration of the study during home visits (twice weekly between study clinic visits) or SAEs were documented by study clinicians at the study clinic or hospital. Adverse events solicited included: diarrhea, vomiting, reported fever, cough, and cold/runny nose. Any other adverse event that was not considered an SAE was documented as "any other illness".
|
75.5%
117/155 • from first day of study to 4 weeks after last dose (11 weeks)
Field workers documented information on severe adverse events (SAEs) through the duration of the study during home visits (twice weekly between study clinic visits) or SAEs were documented by study clinicians at the study clinic or hospital. Adverse events solicited included: diarrhea, vomiting, reported fever, cough, and cold/runny nose. Any other adverse event that was not considered an SAE was documented as "any other illness".
|
70.1%
108/154 • from first day of study to 4 weeks after last dose (11 weeks)
Field workers documented information on severe adverse events (SAEs) through the duration of the study during home visits (twice weekly between study clinic visits) or SAEs were documented by study clinicians at the study clinic or hospital. Adverse events solicited included: diarrhea, vomiting, reported fever, cough, and cold/runny nose. Any other adverse event that was not considered an SAE was documented as "any other illness".
|
64.5%
100/155 • from first day of study to 4 weeks after last dose (11 weeks)
Field workers documented information on severe adverse events (SAEs) through the duration of the study during home visits (twice weekly between study clinic visits) or SAEs were documented by study clinicians at the study clinic or hospital. Adverse events solicited included: diarrhea, vomiting, reported fever, cough, and cold/runny nose. Any other adverse event that was not considered an SAE was documented as "any other illness".
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
84.4%
130/154 • from first day of study to 4 weeks after last dose (11 weeks)
Field workers documented information on severe adverse events (SAEs) through the duration of the study during home visits (twice weekly between study clinic visits) or SAEs were documented by study clinicians at the study clinic or hospital. Adverse events solicited included: diarrhea, vomiting, reported fever, cough, and cold/runny nose. Any other adverse event that was not considered an SAE was documented as "any other illness".
|
86.5%
134/155 • from first day of study to 4 weeks after last dose (11 weeks)
Field workers documented information on severe adverse events (SAEs) through the duration of the study during home visits (twice weekly between study clinic visits) or SAEs were documented by study clinicians at the study clinic or hospital. Adverse events solicited included: diarrhea, vomiting, reported fever, cough, and cold/runny nose. Any other adverse event that was not considered an SAE was documented as "any other illness".
|
83.1%
128/154 • from first day of study to 4 weeks after last dose (11 weeks)
Field workers documented information on severe adverse events (SAEs) through the duration of the study during home visits (twice weekly between study clinic visits) or SAEs were documented by study clinicians at the study clinic or hospital. Adverse events solicited included: diarrhea, vomiting, reported fever, cough, and cold/runny nose. Any other adverse event that was not considered an SAE was documented as "any other illness".
|
83.9%
130/155 • from first day of study to 4 weeks after last dose (11 weeks)
Field workers documented information on severe adverse events (SAEs) through the duration of the study during home visits (twice weekly between study clinic visits) or SAEs were documented by study clinicians at the study clinic or hospital. Adverse events solicited included: diarrhea, vomiting, reported fever, cough, and cold/runny nose. Any other adverse event that was not considered an SAE was documented as "any other illness".
|
|
Respiratory, thoracic and mediastinal disorders
Cold/runny nose
|
92.9%
143/154 • from first day of study to 4 weeks after last dose (11 weeks)
Field workers documented information on severe adverse events (SAEs) through the duration of the study during home visits (twice weekly between study clinic visits) or SAEs were documented by study clinicians at the study clinic or hospital. Adverse events solicited included: diarrhea, vomiting, reported fever, cough, and cold/runny nose. Any other adverse event that was not considered an SAE was documented as "any other illness".
|
95.5%
148/155 • from first day of study to 4 weeks after last dose (11 weeks)
Field workers documented information on severe adverse events (SAEs) through the duration of the study during home visits (twice weekly between study clinic visits) or SAEs were documented by study clinicians at the study clinic or hospital. Adverse events solicited included: diarrhea, vomiting, reported fever, cough, and cold/runny nose. Any other adverse event that was not considered an SAE was documented as "any other illness".
|
90.9%
140/154 • from first day of study to 4 weeks after last dose (11 weeks)
Field workers documented information on severe adverse events (SAEs) through the duration of the study during home visits (twice weekly between study clinic visits) or SAEs were documented by study clinicians at the study clinic or hospital. Adverse events solicited included: diarrhea, vomiting, reported fever, cough, and cold/runny nose. Any other adverse event that was not considered an SAE was documented as "any other illness".
|
92.9%
144/155 • from first day of study to 4 weeks after last dose (11 weeks)
Field workers documented information on severe adverse events (SAEs) through the duration of the study during home visits (twice weekly between study clinic visits) or SAEs were documented by study clinicians at the study clinic or hospital. Adverse events solicited included: diarrhea, vomiting, reported fever, cough, and cold/runny nose. Any other adverse event that was not considered an SAE was documented as "any other illness".
|
|
General disorders
Any other illness
|
20.1%
31/154 • from first day of study to 4 weeks after last dose (11 weeks)
Field workers documented information on severe adverse events (SAEs) through the duration of the study during home visits (twice weekly between study clinic visits) or SAEs were documented by study clinicians at the study clinic or hospital. Adverse events solicited included: diarrhea, vomiting, reported fever, cough, and cold/runny nose. Any other adverse event that was not considered an SAE was documented as "any other illness".
|
21.9%
34/155 • from first day of study to 4 weeks after last dose (11 weeks)
Field workers documented information on severe adverse events (SAEs) through the duration of the study during home visits (twice weekly between study clinic visits) or SAEs were documented by study clinicians at the study clinic or hospital. Adverse events solicited included: diarrhea, vomiting, reported fever, cough, and cold/runny nose. Any other adverse event that was not considered an SAE was documented as "any other illness".
|
24.0%
37/154 • from first day of study to 4 weeks after last dose (11 weeks)
Field workers documented information on severe adverse events (SAEs) through the duration of the study during home visits (twice weekly between study clinic visits) or SAEs were documented by study clinicians at the study clinic or hospital. Adverse events solicited included: diarrhea, vomiting, reported fever, cough, and cold/runny nose. Any other adverse event that was not considered an SAE was documented as "any other illness".
|
16.8%
26/155 • from first day of study to 4 weeks after last dose (11 weeks)
Field workers documented information on severe adverse events (SAEs) through the duration of the study during home visits (twice weekly between study clinic visits) or SAEs were documented by study clinicians at the study clinic or hospital. Adverse events solicited included: diarrhea, vomiting, reported fever, cough, and cold/runny nose. Any other adverse event that was not considered an SAE was documented as "any other illness".
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place