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| Name | Class |
|---|---|
| Christian Medical College, Vellore, India | OTHER |
| Ministry of Science and Technology, India | OTHER_GOV |
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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.
Co- Primary objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zinc and probiotic | Experimental | Received daily zinc and probiotic supplements, in addition to rotavirus vaccine and trivalent oral polio vaccines. |
|
| Zinc alone | Active Comparator | Received daily zinc and probiotic placebo supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine. |
|
| Probiotic alone | Active Comparator | Received daily zinc placebo and probiotic supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine. |
|
| Placebo | Placebo Comparator | Received daily zinc placebo and probiotic placebo, in addition to rotavirus vaccine and trivalent oral polio vaccine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number/Percentage of Subjects With Immune Response to Rotavirus Vaccine | 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). | from first dose of rotavirus vaccine to 4 weeks after last dose of vaccine |
| Geometric Mean Concentration of Rotavirus-specific IgA | 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 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). | from first dose of rotavirus vaccine to 4 weeks after last dose of vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| Number/Percentage of Subjects With Immune Response to Trivalent Oral Poliovirus Vaccine (OPV) | A 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gagandeep Kang, MD, PhD | Christian Medical Center, Vellore, India | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Christian Medical Center, Vellore | Vellore | Tamil Nadu | 632 004 | India |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Evaluated for Safety |
|
| ||||||||||||||||||
| Received Both Vaccines |
| |||||||||||||||||||
| Blood Analyzed for Immunogenicity |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number/Percentage of Subjects With Immune Response to Rotavirus Vaccine | 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). | Posted | Count of Participants | Participants | from first dose of rotavirus vaccine to 4 weeks after last dose of vaccine |
|
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".
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jorge Flores | PATH | (202) 822-0033 | jeflores@path.org |
Not provided
| ID | Term |
|---|---|
| D011051 | Poliomyelitis |
| ID | Term |
|---|---|
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
| D004769 | Enterovirus Infections |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| D015032 | Zinc |
| D022243 | Rotavirus Vaccines |
| C492457 | RIX4414 vaccine |
| D011055 | Poliovirus Vaccine, Oral |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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|
| Zinc | Dietary Supplement | Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally. |
|
| Probiotic placebo | Dietary Supplement | 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. |
|
| Zinc placebo | Dietary Supplement | 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 | Biological | 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks. |
|
|
| Oral polio vaccine | Biological | A liquid trivalent polio vaccine provided orally at 6 and 10 weeks. |
|
|
| from first dose of OPV to 4 weeks after last dose of OPV |
| Number/Percentage of Subjects Exhibiting Rotavirus Shedding in Stool After Dose 1 | 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. | 0, 4 and/or 7 day post dose 1 of rotavirus vaccine |
| Number/Percentage of Subjects Exhibiting Rotavirus Shedding in Stool After Dose 2 | 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. | 0, 4 and/or 7 day post dose 2 of rotavirus vaccine |
| Serious Adverse Events (SAEs) | Field 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. | from first day of study to 4 weeks after last dose |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Religion | Count of Participants | Participants |
|
| Type of house | Count of Participants | Participants |
|
| OG001 | 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. |
| OG002 | 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. |
| OG003 | Placebo | 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. |
| OG004 | Zinc | All subjects receiving zinc supplementation (zinc and probiotic; zinc and probiotic placebo groups) |
| OG005 | No Zinc | All subjects receiving zinc placebo (group receiving zinc placebo and probiotic, combined with group receiving zinc placebo and probiotic placebo) |
| OG006 | Probiotic | All subjects receiving probiotic supplementation (zinc and probiotic; zinc placebo and probiotic) |
| OG007 | No Probiotic | All subjects receiving probiotic placebo (zinc and probiotic placebo; zinc placebo and probiotic placebo) |
|
|
|
| Primary | Geometric Mean Concentration of Rotavirus-specific IgA | 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 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). | Posted | Geometric Mean | 95% Confidence Interval | titer | from first dose of rotavirus vaccine to 4 weeks after last dose of vaccine |
|
|
|
| Secondary | Number/Percentage of Subjects With Immune Response to Trivalent Oral Poliovirus Vaccine (OPV) | A 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). | Posted | Count of Participants | Participants | from first dose of OPV to 4 weeks after last dose of OPV |
|
|
|
|
| Secondary | Number/Percentage of Subjects Exhibiting Rotavirus Shedding in Stool After Dose 1 | 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. | Subjects who received the vaccination on schedule and had valid stool samples on the days of testing. | Posted | Count of Participants | Participants | 0, 4 and/or 7 day post dose 1 of rotavirus vaccine |
|
|
|
| Secondary | Number/Percentage of Subjects Exhibiting Rotavirus Shedding in Stool After Dose 2 | 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. | Subjects who received the vaccination on schedule and had valid stool samples on the days of testing. | Posted | Count of Participants | Participants | 0, 4 and/or 7 day post dose 2 of rotavirus vaccine |
|
|
|
| Secondary | Serious Adverse Events (SAEs) | Field 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. | Posted | Count of Participants | Participants | from first day of study to 4 weeks after last dose |
|
|
|
| 0 |
| 154 |
| 5 |
| 154 |
| 149 |
| 154 |
| EG001 | 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. | 0 | 155 | 3 | 155 | 152 | 155 |
| EG002 | 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. | 0 | 154 | 2 | 154 | 148 | 154 |
| EG003 | 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. | 0 | 155 | 4 | 155 | 146 | 155 |
| Meningitis | Nervous system disorders | Systematic Assessment |
|
| Bronchiolitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Acute febrile illness | General disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Cold/runny nose | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Any other illness | General disorders | Systematic Assessment |
|
Not provided
Not provided
| D010850 |
| Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009468 | Neuromuscular Diseases |
| D019602 |
| Food and Beverages |
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
| D008670 | Metals |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D023321 | Poliovirus Vaccines |
| Post-vaccination |
|
| No seroconversion |
|
| Mean Difference (Net) |
| -3.1 |
| 2-Sided |
| 95 |
| -8.6 |
| 2.3 |
| Superiority |
| Mean Difference (Net) | -2.0 | 2-Sided | 95 | -9.8 | 5.7 | Superiority |
| No shedding 4 or 7 days post-vaccination |
|
| No shedding 4 or 7 days post-vaccination |
|
| Related SAEs |
|
| No SAEs |
|