Immune Response to Rotavirus Vaccine After a Supplemental Dose Given at 9 Months of Age With Local EPI Vaccines in Mali
Sponsor
PATH (Other)
Overall Status
Completed
CT.gov ID
NCT02286895
Collaborator
Center for Vaccine Development - Mali (Other), University of Maryland (Other)
600
1
2
5
120.9
Study Details
Study Description
Brief Summary
This study is an evaluation of the immune response to pentavalent rotavirus vaccine (PRV) after an additional fourth dose is given at 9 months of age with local World Health Organization (WHO) Expanded Programme on Immunization (EPI) vaccines in Mali.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
Vaccination is the best way to prevent severe rotavirus disease and the deadly, dehydrating diarrhea that it causes. However, given only moderate efficacy in the first year of life and a possible further decline in immunity, it is considered a top priority by public health experts to evaluate the possible value of a "booster" dose of rotavirus vaccine in low income countries to confer longer duration of protection into the second year of life when disease burden continues to be high.
This study is an open-label, individual-randomized, parallel-group, comparative immunogenicity trial. Participating infants randomized to Group A will receive one dose each of measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg) at 9 months of age, and infants randomized to Group B will receive one dose each of MV, YFV, PsA-TT-5μg, and PRV at 9 months of age.
The study will simultaneously evaluate two primary objectives, one for noninferiority of the response to MV given with PRV (co-primary objective 1) and one for noninferiority of the response to YFV given with PRV (co-primary objective 2).
Secondary objectives of the study were the following:
-
To evaluate the non-inferiority of the immune response 3 months post-vaccination (as sero-conversion) to MV given with PRV (Group B) to that given without PRV (Group A).
-
To compare the immune response (as geometric mean titers [GMTs]) to YFV given with PRV (Group B) to that given without PRV (Group A).
-
To evaluate the non-inferiority of the immune response (as sero-response) to PsA-TT-5μg given with PRV (Group B) compared to that given without PRV (Group A).
-
To compare the immune response (as GMTs) to PsA-TT-5μg given with PRV (Group B) to that given without PRV (Group A).
-
To evaluate the superiority of the immune response (as sero-response and geometric mean concentrations [GMCs]) to a supplemental dose of PRV given at 9 months of age with local EPI vaccines (Group B) compared no supplemental dose (Group A).
-
To describe the safety profile of study vaccination with PRV.
Study Design
Study Type:
Interventional
Actual Enrollment
:
600 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Evaluation of the Immune Response to Pentavalent Rotavirus Vaccine After a Supplemental Dose Given at 9 Months of Age With Local EPI Vaccines in Mali
Study Start Date
:
Oct 1, 2014
Actual Primary Completion Date
:
Mar 1, 2015
Actual Study Completion Date
:
Mar 1, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Group A (without rotavirus vaccine) Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg). |
Biological: measles vaccine (MV)
A lyophilized vaccine in a pack containing one vial plus one ampoule of sterile water for injection. After reconstitution, each 0.5 ml/dose of MV contains active substances not less than 1000 units of 50% cell culture infectious doses (CCID50) of MV. Measles Vaccine Live Attenuated virus is propagated on Human Diploid Cells. This MV is currently part of the local EPI program in Mali. This vaccine was administered subcutaneously to the right deltoid.
Biological: yellow fever vaccine (YFV)
A freeze-dried live attenuated yellow fever virus of the 17D strain for injection. After reconstitution, one dose (0.5 ml) contains active substances not less than 1000 units of 50% lethal doses (LD50) of yellow fever virus. This YFV is currently part of the local EPI program in Mali. This vaccine was administered intramuscularly to the left deltoid.
Biological: meningitis conjugate vaccine (PsA-TT-5μg)
A meningococcal A vaccine, with meningococcal A polysaccharide (PsA) conjugated to the carrier protein, tetanus toxoid (TT). After reconstitution, one dose (0.5 ml) contains 5μg meningococcal A polysaccharide and 5-16 μg tetanus toxoid as a carrier protein. PsA-TT-5μg was considered experimental at the initiation of this study, but received approval from the WHO for infants on 30 December 2014. For all participants enrolled January 1st, 2015 or later, PsA-TT-5μg was not included in Group A or Group B, due to its December 2014 expiration date. This vaccine was administered intramuscularly to the right thigh.
Other Names:
|
| Experimental: Group B (with rotavirus vaccine) Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg) plus one oral dose of pentavalent rotavirus vaccine (PRV). |
Biological: pentavalent rotavirus vaccine (PRV)
Each two-ml dose contains 5 live human-bovine reassortant rotaviruses with a minimum of 2.0 - 2.8 x 106 infectious units (IU) per reassortant, depending on the serotype, and not greater than 116 x 106 IU per aggregate dose. Each vaccine dose contains sucrose, sodium citrate, sodium phosphate monobasic monohydrate, sodium hydroxide, polysorbate 80, cell culture media, and trace amounts of fetal bovine serum. RotaTeq contains no preservatives. RotaTeq is a pale yellow clear liquid that may have a pink tint. This vaccine was administered orally.
Other Names:
Biological: measles vaccine (MV)
A lyophilized vaccine in a pack containing one vial plus one ampoule of sterile water for injection. After reconstitution, each 0.5 ml/dose of MV contains active substances not less than 1000 units of 50% cell culture infectious doses (CCID50) of MV. Measles Vaccine Live Attenuated virus is propagated on Human Diploid Cells. This MV is currently part of the local EPI program in Mali. This vaccine was administered subcutaneously to the right deltoid.
Biological: yellow fever vaccine (YFV)
A freeze-dried live attenuated yellow fever virus of the 17D strain for injection. After reconstitution, one dose (0.5 ml) contains active substances not less than 1000 units of 50% lethal doses (LD50) of yellow fever virus. This YFV is currently part of the local EPI program in Mali. This vaccine was administered intramuscularly to the left deltoid.
Biological: meningitis conjugate vaccine (PsA-TT-5μg)
A meningococcal A vaccine, with meningococcal A polysaccharide (PsA) conjugated to the carrier protein, tetanus toxoid (TT). After reconstitution, one dose (0.5 ml) contains 5μg meningococcal A polysaccharide and 5-16 μg tetanus toxoid as a carrier protein. PsA-TT-5μg was considered experimental at the initiation of this study, but received approval from the WHO for infants on 30 December 2014. For all participants enrolled January 1st, 2015 or later, PsA-TT-5μg was not included in Group A or Group B, due to its December 2014 expiration date. This vaccine was administered intramuscularly to the right thigh.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number/Percentage of Subjects With Seroconversion for Anti-measles Immunoglobulin G (IgG) Antibody [28 days post-vaccination]
Measured using a commercially-available Enzyme Linked Immunosorbent Assay (ELISA). Seroconversion was defined as a measurement ≥1.10 geometric mean titer (GMT) at Day 28 among subjects with measurement ≤0.90 at baseline
- Number/Percentage of Subjects With Seroresponses for Yellow Fever Neutralizing Antibody [28 days post-vaccination]
Measured by virus neutralization assay, determined using Robert Koch Institute's yellow fever standard of practice and relative to international scientific references for which the level of anti-YF neutralizing IgG protection was known. Seroresponse was defined as a geometric mean titer (GMT) of at least four times baseline value.
Secondary Outcome Measures
- Number/Percentage of Subjects With Seroconversion for Anti-measles Immunoglobulin G (IgG) Antibody [3 months post-vaccination]
Measured using a commercially-available Enzyme Linked Immunosorbent Assay (ELISA). Seroconversion was defined as a measurement ≥1.10 geometric mean titer (GMT) at Day 28 among subjects with measurement ≤0.90 at baseline.
- Serum Neutralization Geometric Mean Titers for Yellow Fever Vaccine [28 days post-vaccination]
Measured by virus neutralization assay, determined using Robert Koch Institute's yellow fever standard of practice (SOP) and relative to international scientific references for which the level of anti-YF neutralizing IgG protection was known.
- Number/Percentage of Subjects With Seroresponses for Meningitis Conjugate Serum Bactericidal Antibody (SBA) [28 days post-vaccination]
Seroresponse was defined as a geometric mean titer (GMT) of at least four times baseline value. Measured using baby rabbit complement (rSBA).
- Geometric Mean of Meningitis Serum Bactericidal Antibody Titer [Baseline to Day 28]
Measured using baby rabbit complement (rSBA).
- Number/Percentage of Subjects With Anti-rotavirus Immunoglobulin A (IgA) Titer at Least 3 Times Baseline Value [28 days post-vaccination]
Conducted by validated Enzyme Linked Immunosorbent Assay (ELISA). The pre- and post-vaccination samples were to be evaluated in one run for consistency and each specimen was to be tested with a negative control for better specificity.
- Number/Percentage of Subjects With Anti-rotavirus IgA Titer of ≥20 Units/mL [28 days post-vaccination]
Conducted by validated Enzyme Linked Immunosorbent Assay (ELISA). The pre- and post-vaccination samples were to be evaluated in one run for consistency and each specimen was to be tested with a negative control for better specificity.
- Number/Percentage of Subjects With Anti-rotavirus IgA <20 Units/mL at Baseline Visit That Had >=20 Units/mL at Day 28 [28 days post-vaccination]
Conducted by validated Enzyme Linked Immunosorbent Assay (ELISA). The pre- and post-vaccination samples were to be evaluated in one run for consistency and each specimen was to be tested with a negative control for better specificity.
- Number/Percentage of Subjects With Anti-rotavirus IgG Titer at Least 3 Times Baseline Value [28 days post-vaccination]
Conducted by validated Enzyme Linked Immunosorbent Assay (ELISA). The pre- and post-vaccination samples were to be evaluated in one run for consistency and each specimen was to be tested with a negative control for better specificity.
- Number/Percentage of Subjects With Anti-rotavirus IgG Titer of ≥20 Units/mL [28 days post-vaccination]
Conducted by validated Enzyme Linked Immunosorbent Assay (ELISA). The pre- and post-vaccination samples were to be evaluated in one run for consistency and each specimen was to be tested with a negative control for better specificity.
- Number/Percentage of Subjects With Anti-rotavirus IgG <20 Units/mL at Baseline Visit That Had >=20 Units/mL at Day 28 [28 days post-vaccination]
Conducted by validated Enzyme Linked Immunosorbent Assay (ELISA). The pre- and post-vaccination samples were to be evaluated in one run for consistency and each specimen was to be tested with a negative control for better specificity.
- Geometric Mean of Anti-rotavirus IgA Concentration [28 days post-vaccination]
Conducted by validated Enzyme Linked Immunosorbent Assay (ELISA). The pre- and post-vaccination samples were to be evaluated in one run for consistency and each specimen was to be tested with a negative control for better specificity.
- Geometric Mean of Anti-rotavirus IgG Concentration [28 days post-vaccination]
Conducted by validated Enzyme Linked Immunosorbent Assay (ELISA). The pre- and post-vaccination samples were to be evaluated in one run for consistency and each specimen was to be tested with a negative control for better specificity.
- Geometric Mean of Anti-rotavirus IgA Among Subjects With <20 Units/mL Concentration at Baseline [28 days post-vaccination]
Conducted by validated Enzyme Linked Immunosorbent Assay (ELISA). The pre- and post-vaccination samples were to be evaluated in one run for consistency and each specimen was to be tested with a negative control for better specificity.
- Geometric Mean of Anti-rotavirus IgG Among Subjects With <20 Units/mL Concentration at Baseline [28 days post-vaccination]
Conducted by validated Enzyme Linked Immunosorbent Assay (ELISA). The pre- and post-vaccination samples were to be evaluated in one run for consistency and each specimen was to be tested with a negative control for better specificity.
- Number/Percentage of Participants Experiencing Immediate Reactions Post-vaccination [Within 30 minutes post-vaccination]
With emphasis on allergic reactions, observed by study staff
- Number of Solicited Adverse Reactions (AR) Experienced by Participants [7 days post-vaccination]
identified or observed by study staff during home visits and/or reported by a parent at any time. Solicited adverse reactions were graded and sub-categorized as those deemed related to vaccination or not by the investigator.
- Number/Percentage of Participants Experiencing Serious Adverse Events (SAE) [3 months post-vaccination]
Occurring from vaccination through 3 months post-vaccination, identified or observed by study staff and/or reported by a parent at any time. Serious adverse events were graded for severity and sub-categorized as those deemed related to vaccination or not by the investigator.
Eligibility Criteria
Criteria
Ages Eligible for Study:
9 Months
to 11 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
At least 9 months of age through 11 months of age (has not yet reached 1st birthday) at the time of administration of study vaccines.
-
Residence in the study area.
-
At least one parent or guardian who is at least 18 years of age and is willing to provide written informed consent.
-
Generally healthy and free of obvious health problems as established by medical history including physical examination and clinical judgment of the investigator.
-
A child who is fully vaccinated according to the local EPI schedule (exclusive of oral polio vaccine birth dose).
-
A parent or guardian is willing to attend all planned study visits or allow home visits and mobile phone contacts, as required by the protocol.
Exclusion Criteria:
-
Previous receipt any measles-containing vaccine.
-
Previous receipt of any yellow fever vaccine.
-
Previous receipt of any meningitis vaccine.
-
Receipt of rotavirus vaccine within the past 90 days.
-
Administration of any other vaccine within 8 weeks prior to administration of study vaccines or planned vaccination during the 4 weeks after study vaccination.
-
History of allergic disease or known hypersensitivity to any component of the study vaccines and/or following administration of vaccines included in the local program of immunization
-
Use of any investigational or non-registered drug within 90 days prior to the administration of study vaccines.
-
Administration of immunoglobulins and/or any blood products within 90 days prior to the administration of study vaccines or planned administration during the vaccine period.
-
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying agents since birth (including systemic corticosteroids, this means prednisone, or equivalent, ≥0.5 mg/kg/day; topical steroids including inhaled steroids are allowed).
-
A family history of congenital or hereditary immunodeficiency.
-
History of intussusception.
-
Uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception.
-
Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by medical history or physical examination, which in the opinion of the investigator, might interfere with the study objectives.
-
Acute illness at the time of enrollment (acute disease is defined as the presence of a moderate or severe illness with fever [axillary temperature ≥38°C] or without fever [severity determined at the discretion of the investigator]. Acute illness is a temporary exclusion.
-
Any condition or criterion that in the opinion of the investigator might compromise the well-being of the subject or the compliance with study procedures or interfere with the outcome of the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CVD-Mali | Bamako | Mali |
Sponsors and Collaborators
- PATH
- Center for Vaccine Development - Mali
- University of Maryland
Investigators
- Principal Investigator: Samba O Sow, MD, Msc, Center for Vaccine Development - Mali
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
PATH
ClinicalTrials.gov Identifier:
NCT02286895
Other Study ID Numbers:
- PATH-RVI-PRV-01
First Posted:
Nov 10, 2014
Last Update Posted:
Jan 2, 2019
Last Verified:
Dec 1, 2018
Keywords provided by PATH
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Recruited up to 750 healthy male and female infant subjects of 9-11 months of age from the local communities and community health centers in Bamako, Mali. The duration of planned study participation for each subject was to be approximately 3 months and the estimated duration of the recruitment period was to be 3 months. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Group A (Without Rotavirus Vaccine) | Group B (With Rotavirus Vaccine) |
|---|---|---|
| Arm/Group Description | Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg). measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly | Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg) plus one oral dose of pentavalent rotavirus vaccine (PRV). pentavalent rotavirus vaccine (PRV): At enrollment, infants in this group receive one dose of 2.0ml orally measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly |
| Period Title: Randomized and Vaccinated | ||
| STARTED | 300 | 300 |
| COMPLETED | 300 | 300 |
| NOT COMPLETED | 0 | 0 |
| Period Title: Randomized and Vaccinated | ||
| STARTED | 300 | 300 |
| COMPLETED | 252 | 261 |
| NOT COMPLETED | 48 | 39 |
Baseline Characteristics
| Arm/Group Title | Group A (Without Rotavirus Vaccine) | Group B (With Rotavirus Vaccine) | Total |
|---|---|---|---|
| Arm/Group Description | Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg). measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly | Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg) plus one oral dose of pentavalent rotavirus vaccine (PRV). pentavalent rotavirus vaccine (PRV): At enrollment, infants in this group receive one dose of 2.0ml orally measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly | Total of all reporting groups |
| Overall Participants | 300 | 300 | 600 |
| Age (months) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [months] |
9.7
(.7)
|
9.7
(.7)
|
9.7
(.7)
|
| Age, Customized (Count of Participants) | |||
| 9 months |
223
74.3%
|
224
74.7%
|
447
74.5%
|
| 10 months |
53
17.7%
|
51
17%
|
104
17.3%
|
| 11 months |
24
8%
|
25
8.3%
|
49
8.2%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
133
44.3%
|
151
50.3%
|
284
47.3%
|
| Male |
167
55.7%
|
149
49.7%
|
316
52.7%
|
| Region of Enrollment (participants) [Number] | |||
| Mali |
300
100%
|
300
100%
|
600
100%
|
| Ethnicity (Count of Participants) | |||
| Bambara |
101
33.7%
|
120
40%
|
221
36.8%
|
| Mandika/Malinke |
41
13.7%
|
37
12.3%
|
78
13%
|
| Fula/Peulh |
49
16.3%
|
34
11.3%
|
83
13.8%
|
| Sarahule/Sarakole |
35
11.7%
|
37
12.3%
|
72
12%
|
| Other |
74
24.7%
|
72
24%
|
146
24.3%
|
Outcome Measures
| Title | Number/Percentage of Subjects With Seroconversion for Anti-measles Immunoglobulin G (IgG) Antibody |
|---|---|
| Description | Measured using a commercially-available Enzyme Linked Immunosorbent Assay (ELISA). Seroconversion was defined as a measurement ≥1.10 geometric mean titer (GMT) at Day 28 among subjects with measurement ≤0.90 at baseline |
| Time Frame | 28 days post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of subjects with valid measurements and measurement ≤0.90 at baseline (per protocol) |
| Arm/Group Title | Group A (Without Rotavirus Vaccine) | Group B (With Rotavirus Vaccine) |
|---|---|---|
| Arm/Group Description | Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg). measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly | Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg) plus one oral dose of pentavalent rotavirus vaccine (PRV). pentavalent rotavirus vaccine (PRV): At enrollment, infants in this group receive one dose of 2.0ml orally measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly |
| Measure Participants | 252 | 261 |
| Seroconversion |
246
82%
|
255
85%
|
| No seroconversion (≤0.90) |
2
0.7%
|
3
1%
|
| Equivocal measurements (≥0.91 and ≤1.09) |
4
1.3%
|
3
1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group A (Without Rotavirus Vaccine), Group B (With Rotavirus Vaccine) |
|---|---|---|
| Comments | Based on results from a prior study, the sponsor assumed 90% sero-conversion rates in each Arms A and B for each antigen in the two co-primary objectives. To rule out a non-inferiority margin of no more than 10% with 95% power (95% power was chosen to give an overall power of at least 90%) and a one-sided type-one error rate of no more than 2.5%, 237 evaluable subjects were required in each group to explore the co-primary objectives. | |
| Type of Statistical Test | Non-Inferiority | |
| Comments | The protocol stated that non-inferiority would be achieved if the lower limit of the 95% confidence interval (2-sided) for the difference in sero-conversion percentages (group receiving rotavirus minus group not receiving rotavirus) was > -10%. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 0.1 | |
| Confidence Interval |
(2-Sided) 95% -4.0 to 4.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number/Percentage of Subjects With Seroresponses for Yellow Fever Neutralizing Antibody |
|---|---|
| Description | Measured by virus neutralization assay, determined using Robert Koch Institute's yellow fever standard of practice and relative to international scientific references for which the level of anti-YF neutralizing IgG protection was known. Seroresponse was defined as a geometric mean titer (GMT) of at least four times baseline value. |
| Time Frame | 28 days post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of subjects with valid measurements and negative result at baseline (per protocol) |
| Arm/Group Title | Group A (Without Rotavirus Vaccine) | Group B (With Rotavirus Vaccine) |
|---|---|---|
| Arm/Group Description | Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg). measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly | Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg) plus one oral dose of pentavalent rotavirus vaccine (PRV). pentavalent rotavirus vaccine (PRV): At enrollment, infants in this group receive one dose of 2.0ml orally measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly |
| Measure Participants | 290 | 287 |
| Seroresponse |
153
51%
|
141
47%
|
| No seroresponse |
137
45.7%
|
146
48.7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group A (Without Rotavirus Vaccine), Group B (With Rotavirus Vaccine) |
|---|---|---|
| Comments | Based on results from a prior study completed by PATH and CVD-Mali, the sponsor assumed 90% sero-conversion rates in each Arms A and B for each antigen in the two co-primary objectives. To rule out a non-inferiority margin of no more than 10% with 95% power (95% power was chosen to give an overall power of at least 90%) and a one-sided type-one error rate of no more than 2.5%, 237 evaluable subjects were required in each group to explore the co-primary objectives. | |
| Type of Statistical Test | Non-Inferiority | |
| Comments | The protocol stated that non-inferiority would be achieved if the lower limit of the 95% CI (2-sided) for the difference in sero-conversion percentages (group receiving rotavirus minus group not receiving rotavirus) was > -10%. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -4.1 | |
| Confidence Interval |
(2-Sided) 95% -12.2 to 4.0 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number/Percentage of Subjects With Seroconversion for Anti-measles Immunoglobulin G (IgG) Antibody |
|---|---|
| Description | Measured using a commercially-available Enzyme Linked Immunosorbent Assay (ELISA). Seroconversion was defined as a measurement ≥1.10 geometric mean titer (GMT) at Day 28 among subjects with measurement ≤0.90 at baseline. |
| Time Frame | 3 months post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects with valid measurements and measurement ≤0.90 at baseline (per protocol) |
| Arm/Group Title | Group A (Without Rotavirus Vaccine) | Group B (With Rotavirus Vaccine) |
|---|---|---|
| Arm/Group Description | Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg). measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly | Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg) plus one oral dose of pentavalent rotavirus vaccine (PRV). pentavalent rotavirus vaccine (PRV): At enrollment, infants in this group receive one dose of 2.0ml orally measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly |
| Measure Participants | 218 | 228 |
| Seroconversion |
206
68.7%
|
210
70%
|
| No seroconversion (≤0.90) |
4
1.3%
|
5
1.7%
|
| Equivocal measurements (≥0.91 and ≤1.09) |
8
2.7%
|
13
4.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group A (Without Rotavirus Vaccine), Group B (With Rotavirus Vaccine) |
|---|---|---|
| Comments | Based on results from a prior study completed by PATH and CVD-Mali, the sponsor assumed 90% sero-conversion rates in each Arms A and B for each antigen in the two co-primary objectives. To rule out a non-inferiority margin of no more than 10% with 95% power (95% power was chosen to give an overall power of at least 90%) and a one-sided type-one error rate of no more than 2.5%, 237 evaluable subjects were required in each group to explore the co-primary objectives. | |
| Type of Statistical Test | Non-Inferiority | |
| Comments | The protocol stated that non-inferiority would be achieved if the lower limit of the 95% confidence interval (2-sided) for the difference in sero-conversion percentages (group receiving rotavirus minus group not receiving rotavirus) was > -10%. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -2.4 | |
| Confidence Interval |
(2-Sided) 95% -7.5 to 2.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Serum Neutralization Geometric Mean Titers for Yellow Fever Vaccine |
|---|---|
| Description | Measured by virus neutralization assay, determined using Robert Koch Institute's yellow fever standard of practice (SOP) and relative to international scientific references for which the level of anti-YF neutralizing IgG protection was known. |
| Time Frame | 28 days post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of subjects with valid measurements (per protocol) |
| Arm/Group Title | Group A (Without Rotavirus Vaccine) | Group B (With Rotavirus Vaccine) |
|---|---|---|
| Arm/Group Description | Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg). measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly | Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg) plus one oral dose of pentavalent rotavirus vaccine (PRV). pentavalent rotavirus vaccine (PRV): At enrollment, infants in this group receive one dose of 2.0ml orally measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly |
| Measure Participants | 293 | 293 |
| Baseline |
2.4
|
2.5
|
| 28 days post-vaccination |
16.8
|
15
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group A (Without Rotavirus Vaccine), Group B (With Rotavirus Vaccine) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Equivalence | |
| Comments | Definition of equivalence/null hypothesis: geometric mean titer (GMT) of group receiving rotavirus vaccine divided by GMT of group not receiving rotavirus vaccine = 1. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | geometric mean titer ratio |
| Estimated Value | 0.9 | |
| Confidence Interval |
(2-Sided) 95% 0.8 to 1.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number/Percentage of Subjects With Seroresponses for Meningitis Conjugate Serum Bactericidal Antibody (SBA) |
|---|---|
| Description | Seroresponse was defined as a geometric mean titer (GMT) of at least four times baseline value. Measured using baby rabbit complement (rSBA). |
| Time Frame | 28 days post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of subjects with valid measurements (per protocol) |
| Arm/Group Title | Group A (Without Rotavirus Vaccine) | Group B (With Rotavirus Vaccine) |
|---|---|---|
| Arm/Group Description | Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg). measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly | Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg) plus one oral dose of pentavalent rotavirus vaccine (PRV). pentavalent rotavirus vaccine (PRV): At enrollment, infants in this group receive one dose of 2.0ml orally measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly |
| Measure Participants | 293 | 292 |
| Seroresponse |
276
92%
|
273
91%
|
| No seroresponse |
17
5.7%
|
19
6.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group A (Without Rotavirus Vaccine), Group B (With Rotavirus Vaccine) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Equivalence | |
| Comments | Definition of equivalence/null hypothesis: geometric mean concentration (GMC) of group receiving rotavirus vaccine/ GMC of group not receiving rotavirus vaccine = 1 | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | geometric mean titer ratio |
| Estimated Value | -0.7 | |
| Confidence Interval |
(2-Sided) 95% -5.2 to 3.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Geometric Mean of Meningitis Serum Bactericidal Antibody Titer |
|---|---|
| Description | Measured using baby rabbit complement (rSBA). |
| Time Frame | Baseline to Day 28 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of subjects with valid measurements (per protocol) |
| Arm/Group Title | Group A (Without Rotavirus Vaccine) | Group B (With Rotavirus Vaccine) |
|---|---|---|
| Arm/Group Description | Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg). measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly | Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg) plus one oral dose of pentavalent rotavirus vaccine (PRV). pentavalent rotavirus vaccine (PRV): At enrollment, infants in this group receive one dose of 2.0ml orally measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly |
| Measure Participants | 293 | 292 |
| Geometric Mean (95% Confidence Interval) [titer] |
2.8
|
3.2
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group A (Without Rotavirus Vaccine), Group B (With Rotavirus Vaccine) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Equivalence | |
| Comments | Definition of equivalence/null hypothesis: geometric mean titer (GMT) of group receiving rotavirus vaccine divided by GMT of group not receiving rotavirus vaccine = 1. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | geometric mean titer ratio |
| Estimated Value | 0.9 | |
| Confidence Interval |
(2-Sided) 95% 0.7 to 1.3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number/Percentage of Subjects With Anti-rotavirus Immunoglobulin A (IgA) Titer at Least 3 Times Baseline Value |
|---|---|
| Description | Conducted by validated Enzyme Linked Immunosorbent Assay (ELISA). The pre- and post-vaccination samples were to be evaluated in one run for consistency and each specimen was to be tested with a negative control for better specificity. |
| Time Frame | 28 days post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of subjects with valid measurements (per protocol) |
| Arm/Group Title | Group A (Without Rotavirus Vaccine) | Group B (With Rotavirus Vaccine) |
|---|---|---|
| Arm/Group Description | Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg). measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly | Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg) plus one oral dose of pentavalent rotavirus vaccine (PRV). pentavalent rotavirus vaccine (PRV): At enrollment, infants in this group receive one dose of 2.0ml orally measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly |
| Measure Participants | 292 | 292 |
| At least 3 times baseline value |
80
26.7%
|
131
43.7%
|
| Not at least 3 times baseline value |
212
70.7%
|
161
53.7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group A (Without Rotavirus Vaccine), Group B (With Rotavirus Vaccine) |
|---|---|---|
| Comments | Null hypothesis: percentage of the seroresponse to rotavirus in the group that received rotavirus vaccine minus the percentage of the seroresponse to rotavirus in the group that did not receive rotavirus vaccine is less than or equal to 0. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 17.5 | |
| Confidence Interval |
(2-Sided) 95% 9.7 to 25.3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number/Percentage of Subjects With Anti-rotavirus IgA Titer of ≥20 Units/mL |
|---|---|
| Description | Conducted by validated Enzyme Linked Immunosorbent Assay (ELISA). The pre- and post-vaccination samples were to be evaluated in one run for consistency and each specimen was to be tested with a negative control for better specificity. |
| Time Frame | 28 days post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of subjects with valid measurements (per protocol) |
| Arm/Group Title | Group A (Without Rotavirus Vaccine) | Group B (With Rotavirus Vaccine) |
|---|---|---|
| Arm/Group Description | Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg). measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly | Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg) plus one oral dose of pentavalent rotavirus vaccine (PRV). pentavalent rotavirus vaccine (PRV): At enrollment, infants in this group receive one dose of 2.0ml orally measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly |
| Measure Participants | 292 | 292 |
| ≥20 Units/mL |
172
57.3%
|
218
72.7%
|
| <20 Units/mL |
120
40%
|
74
24.7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group A (Without Rotavirus Vaccine), Group B (With Rotavirus Vaccine) |
|---|---|---|
| Comments | Null hypothesis: percentage of the seroresponse to rotavirus in the group that received rotavirus vaccine minus the percentage of the seroresponse to rotavirus in the group that did not receive rotavirus vaccine is less than or equal to 0. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 15.8 | |
| Confidence Interval |
(2-Sided) 95% 8.1 to 23.4 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number/Percentage of Subjects With Anti-rotavirus IgA <20 Units/mL at Baseline Visit That Had >=20 Units/mL at Day 28 |
|---|---|
| Description | Conducted by validated Enzyme Linked Immunosorbent Assay (ELISA). The pre- and post-vaccination samples were to be evaluated in one run for consistency and each specimen was to be tested with a negative control for better specificity. |
| Time Frame | 28 days post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants with valid measures of anti-rotavirus IgA <20 units/mL at baseline |
| Arm/Group Title | Group A (Without Rotavirus Vaccine) | Group B (With Rotavirus Vaccine) |
|---|---|---|
| Arm/Group Description | Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg). measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly | Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg) plus one oral dose of pentavalent rotavirus vaccine (PRV). pentavalent rotavirus vaccine (PRV): At enrollment, infants in this group receive one dose of 2.0ml orally measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly |
| Measure Participants | 165 | 160 |
| Seroresponse |
52
17.3%
|
91
30.3%
|
| No seroresponse |
113
37.7%
|
69
23%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group A (Without Rotavirus Vaccine), Group B (With Rotavirus Vaccine) |
|---|---|---|
| Comments | Null hypothesis: percentage of the seroresponse to rotavirus in the group that received rotavirus vaccine minus the percentage of the seroresponse to rotavirus in the group that did not receive rotavirus vaccine is less than or equal to 0. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 25.4 | |
| Confidence Interval |
(2-Sided) 95% 14.6 to 36.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number/Percentage of Subjects With Anti-rotavirus IgG Titer at Least 3 Times Baseline Value |
|---|---|
| Description | Conducted by validated Enzyme Linked Immunosorbent Assay (ELISA). The pre- and post-vaccination samples were to be evaluated in one run for consistency and each specimen was to be tested with a negative control for better specificity. |
| Time Frame | 28 days post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Group A (Without Rotavirus Vaccine) | Group B (With Rotavirus Vaccine) |
|---|---|---|
| Arm/Group Description | Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg). measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly | Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg) plus one oral dose of pentavalent rotavirus vaccine (PRV). pentavalent rotavirus vaccine (PRV): At enrollment, infants in this group receive one dose of 2.0ml orally measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly |
| Measure Participants | 293 | 293 |
| Seroresponse |
77
25.7%
|
168
56%
|
| No seroresponse |
216
72%
|
125
41.7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group A (Without Rotavirus Vaccine), Group B (With Rotavirus Vaccine) |
|---|---|---|
| Comments | Null hypothesis: percentage of the seroresponse to rotavirus in the group that received rotavirus vaccine minus the percentage of the seroresponse to rotavirus in the group that did not receive rotavirus vaccine is less than or equal to 0. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 31.1 | |
| Confidence Interval |
(2-Sided) 95% 23.1 to 39.0 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number/Percentage of Subjects With Anti-rotavirus IgG Titer of ≥20 Units/mL |
|---|---|
| Description | Conducted by validated Enzyme Linked Immunosorbent Assay (ELISA). The pre- and post-vaccination samples were to be evaluated in one run for consistency and each specimen was to be tested with a negative control for better specificity. |
| Time Frame | 28 days post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of subjects with valid measurements (per protocol) |
| Arm/Group Title | Group A (Without Rotavirus Vaccine) | Group B (With Rotavirus Vaccine) |
|---|---|---|
| Arm/Group Description | Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg). measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly | Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg) plus one oral dose of pentavalent rotavirus vaccine (PRV). pentavalent rotavirus vaccine (PRV): At enrollment, infants in this group receive one dose of 2.0ml orally measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly |
| Measure Participants | 293 | 293 |
| ≥20 Units/mL |
223
74.3%
|
275
91.7%
|
| <20 Units/mL |
70
23.3%
|
18
6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group A (Without Rotavirus Vaccine), Group B (With Rotavirus Vaccine) |
|---|---|---|
| Comments | Null hypothesis: percentage of the seroresponse to rotavirus in the group that received rotavirus vaccine minus the percentage of the seroresponse to rotavirus in the group that did not receive rotavirus vaccine is less than or equal to 0. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 17.7 | |
| Confidence Interval |
(2-Sided) 95% 12.0 to 23.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number/Percentage of Subjects With Anti-rotavirus IgG <20 Units/mL at Baseline Visit That Had >=20 Units/mL at Day 28 |
|---|---|
| Description | Conducted by validated Enzyme Linked Immunosorbent Assay (ELISA). The pre- and post-vaccination samples were to be evaluated in one run for consistency and each specimen was to be tested with a negative control for better specificity. |
| Time Frame | 28 days post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants with valid measures of anti-rotavirus IgA <20 units/mL at baseline |
| Arm/Group Title | Group A (Without Rotavirus Vaccine) | Group B (With Rotavirus Vaccine) |
|---|---|---|
| Arm/Group Description | Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg). measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly | Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg) plus one oral dose of pentavalent rotavirus vaccine (PRV). pentavalent rotavirus vaccine (PRV): At enrollment, infants in this group receive one dose of 2.0ml orally measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly |
| Measure Participants | 92 | 91 |
| Seroresponse |
29
9.7%
|
76
25.3%
|
| No seroresponse |
63
21%
|
15
5%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group A (Without Rotavirus Vaccine), Group B (With Rotavirus Vaccine) |
|---|---|---|
| Comments | Null hypothesis: percentage of the seroresponse to rotavirus in the group that received rotavirus vaccine minus the percentage of the seroresponse to rotavirus in the group that did not receive rotavirus vaccine is less than or equal to 0. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 52.0 | |
| Confidence Interval |
(2-Sided) 95% 37.7 to 66.3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Geometric Mean of Anti-rotavirus IgA Concentration |
|---|---|
| Description | Conducted by validated Enzyme Linked Immunosorbent Assay (ELISA). The pre- and post-vaccination samples were to be evaluated in one run for consistency and each specimen was to be tested with a negative control for better specificity. |
| Time Frame | 28 days post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of subjects with valid measurements (per protocol) |
| Arm/Group Title | Group A (Without Rotavirus Vaccine) | Group B (With Rotavirus Vaccine) |
|---|---|---|
| Arm/Group Description | Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg). measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly | Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg) plus one oral dose of pentavalent rotavirus vaccine (PRV). pentavalent rotavirus vaccine (PRV): At enrollment, infants in this group receive one dose of 2.0ml orally measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly |
| Measure Participants | 292 | 292 |
| Baseline |
23.7
|
25.3
|
| 28 days post-vaccination |
67.9
|
118.4
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group A (Without Rotavirus Vaccine), Group B (With Rotavirus Vaccine) |
|---|---|---|
| Comments | Null hypothesis: geometric mean titer (GMT) in group receiving rotavirus vaccine/GMT in group not receiving rotavirus vaccine ≤ 1 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | geometric mean titer ratio |
| Estimated Value | 1.7 | |
| Confidence Interval |
(2-Sided) 95% 1.2 to 2.4 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Geometric Mean of Anti-rotavirus IgG Concentration |
|---|---|
| Description | Conducted by validated Enzyme Linked Immunosorbent Assay (ELISA). The pre- and post-vaccination samples were to be evaluated in one run for consistency and each specimen was to be tested with a negative control for better specificity. |
| Time Frame | 28 days post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of subjects with valid measurements (per protocol) |
| Arm/Group Title | Group A (Without Rotavirus Vaccine) | Group B (With Rotavirus Vaccine) |
|---|---|---|
| Arm/Group Description | Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg). measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly | Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg) plus one oral dose of pentavalent rotavirus vaccine (PRV). pentavalent rotavirus vaccine (PRV): At enrollment, infants in this group receive one dose of 2.0ml orally measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly |
| Measure Participants | 293 | 293 |
| Baseline |
58.9
|
62.5
|
| 28 days post-vaccination |
153.3
|
363.6
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group A (Without Rotavirus Vaccine), Group B (With Rotavirus Vaccine) |
|---|---|---|
| Comments | Null hypothesis: 28 days post-vaccination, geometric mean titer (GMT) in group receiving rotavirus vaccine/GMT in group not receiving rotavirus vaccine ≤ 1 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | geometric mean titer ratio |
| Estimated Value | 2.3 | |
| Confidence Interval |
(2-Sided) 95% 1.7 to 3.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Geometric Mean of Anti-rotavirus IgA Among Subjects With <20 Units/mL Concentration at Baseline |
|---|---|
| Description | Conducted by validated Enzyme Linked Immunosorbent Assay (ELISA). The pre- and post-vaccination samples were to be evaluated in one run for consistency and each specimen was to be tested with a negative control for better specificity. |
| Time Frame | 28 days post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Group A (Without Rotavirus Vaccine) | Group B (With Rotavirus Vaccine) |
|---|---|---|
| Arm/Group Description | Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg). measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly | Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg) plus one oral dose of pentavalent rotavirus vaccine (PRV). pentavalent rotavirus vaccine (PRV): At enrollment, infants in this group receive one dose of 2.0ml orally measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly |
| Measure Participants | 165 | 160 |
| Baseline |
5.1
|
4.8
|
| 28 days post-vaccination |
22.2
|
41.5
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group A (Without Rotavirus Vaccine), Group B (With Rotavirus Vaccine) |
|---|---|---|
| Comments | Null hypothesis: geometric mean titer (GMT) in group receiving rotavirus vaccine/GMT in group not receiving rotavirus vaccine ≤ 1 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | geometric mean titer ratio |
| Estimated Value | 2.0 | |
| Confidence Interval |
(2-Sided) 95% 1.2 to 3.3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Geometric Mean of Anti-rotavirus IgG Among Subjects With <20 Units/mL Concentration at Baseline |
|---|---|
| Description | Conducted by validated Enzyme Linked Immunosorbent Assay (ELISA). The pre- and post-vaccination samples were to be evaluated in one run for consistency and each specimen was to be tested with a negative control for better specificity. |
| Time Frame | 28 days post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants with valid measures of anti-rotavirus IgG <20 units/mL at baseline |
| Arm/Group Title | Group A (Without Rotavirus Vaccine) | Group B (With Rotavirus Vaccine) |
|---|---|---|
| Arm/Group Description | Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg). measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly | Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg) plus one oral dose of pentavalent rotavirus vaccine (PRV). pentavalent rotavirus vaccine (PRV): At enrollment, infants in this group receive one dose of 2.0ml orally measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly |
| Measure Participants | 92 | 91 |
| Baseline |
7.8
|
7.4
|
| 28 days post-vaccination |
28.3
|
123.7
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group A (Without Rotavirus Vaccine), Group B (With Rotavirus Vaccine) |
|---|---|---|
| Comments | Null hypothesis: geometric mean titer (GMT) in group receiving rotavirus vaccine/GMT in group not receiving rotavirus vaccine ≤ 1 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | geometric mean titer ratio |
| Estimated Value | 4.6 | |
| Confidence Interval |
(2-Sided) 95% 2.4 to 8.9 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number/Percentage of Participants Experiencing Immediate Reactions Post-vaccination |
|---|---|
| Description | With emphasis on allergic reactions, observed by study staff |
| Time Frame | Within 30 minutes post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Among all subjects enrolled (intent-to-treat population) |
| Arm/Group Title | Group A (Without Rotavirus Vaccine) | Group B (With Rotavirus Vaccine) |
|---|---|---|
| Arm/Group Description | Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg). measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly | Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg) plus one oral dose of pentavalent rotavirus vaccine (PRV). pentavalent rotavirus vaccine (PRV): At enrollment, infants in this group receive one dose of 2.0ml orally measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly |
| Measure Participants | 300 | 300 |
| Any immediate reaction |
0
0%
|
0
0%
|
| No immediate reaction |
300
100%
|
300
100%
|
| Title | Number of Solicited Adverse Reactions (AR) Experienced by Participants |
|---|---|
| Description | identified or observed by study staff during home visits and/or reported by a parent at any time. Solicited adverse reactions were graded and sub-categorized as those deemed related to vaccination or not by the investigator. |
| Time Frame | 7 days post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Group A (Without Rotavirus Vaccine) | Group B (With Rotavirus Vaccine) |
|---|---|---|
| Arm/Group Description | Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg). measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly | Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg) plus one oral dose of pentavalent rotavirus vaccine (PRV). pentavalent rotavirus vaccine (PRV): At enrollment, infants in this group receive one dose of 2.0ml orally measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly |
| Measure Participants | 300 | 300 |
| Measure systemic reaction | 41 | 38 |
| Diarrhea |
24
|
21
|
| Vomiting |
8
|
7
|
| Pyrexia |
5
|
8
|
| Irritability |
1
|
2
|
| Lethargy |
2
|
0
|
| Rash |
1
|
0
|
| Title | Number/Percentage of Participants Experiencing Serious Adverse Events (SAE) |
|---|---|
| Description | Occurring from vaccination through 3 months post-vaccination, identified or observed by study staff and/or reported by a parent at any time. Serious adverse events were graded for severity and sub-categorized as those deemed related to vaccination or not by the investigator. |
| Time Frame | 3 months post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Among all subjects enrolled (intent-to-treat population) |
| Arm/Group Title | Group A (Without Rotavirus Vaccine) | Group B (With Rotavirus Vaccine) |
|---|---|---|
| Arm/Group Description | Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg). measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly | Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg) plus one oral dose of pentavalent rotavirus vaccine (PRV). pentavalent rotavirus vaccine (PRV): At enrollment, infants in this group receive one dose of 2.0ml orally measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly |
| Measure Participants | 300 | 300 |
| At least 1 SAE probably related to vaccination |
1
0.3%
|
0
0%
|
| At least 1 SAE not related to vaccination |
6
2%
|
7
2.3%
|
| No SAE |
292
97.3%
|
293
97.7%
|
| 1 SAE unlikely to be related to vaccination |
1
0.3%
|
0
0%
|
Adverse Events
| Time Frame | 3 months post-vaccination (death and serious adverse events), 28 days (all other adverse events) | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Field staff members visited study subjects on Days 1 through 5 to inquire about specific local and systemic signs and symptoms. On Day 7, a physician visited the subject's home for evaluation. Subjects returned to the study center on Day 28 and Day 84 for evaluation. After Day 28, only SAEs (with the exception of signs of potential intussusception) did not require documentation. A malaria test was conducted on Days 0, 28, and 84. | |||
| Arm/Group Title | Group A (Without Rotavirus Vaccine) | Group B (With Rotavirus Vaccine) | ||
| Arm/Group Description | Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg). measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly | Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg) plus one oral dose of pentavalent rotavirus vaccine (PRV). pentavalent rotavirus vaccine (PRV): At enrollment, infants in this group receive one dose of 2.0ml orally measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly | ||
All Cause Mortality |
||||
| Group A (Without Rotavirus Vaccine) | Group B (With Rotavirus Vaccine) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/300 (0%) | 0/300 (0%) | ||
Serious Adverse Events |
||||
| Group A (Without Rotavirus Vaccine) | Group B (With Rotavirus Vaccine) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 8/300 (2.7%) | 7/300 (2.3%) | ||
| Gastrointestinal disorders | ||||
| Gastroenteritis | 2/300 (0.7%) | 2/300 (0.7%) | ||
| Infections and infestations | ||||
| Bronchitis | 2/300 (0.7%) | 0/300 (0%) | ||
| Malaria | 1/300 (0.3%) | 5/300 (1.7%) | ||
| Pharyngitis | 1/300 (0.3%) | 0/300 (0%) | ||
| Pneumonia | 1/300 (0.3%) | 0/300 (0%) | ||
| Injury, poisoning and procedural complications | ||||
| Burns second degree | 1/300 (0.3%) | 0/300 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Group A (Without Rotavirus Vaccine) | Group B (With Rotavirus Vaccine) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 125/300 (41.7%) | 103/300 (34.3%) | ||
| Blood and lymphatic system disorders | ||||
| Anemia | 1/300 (0.3%) | 1 | 0/300 (0%) | 0 |
| Ear and labyrinth disorders | ||||
| Otitis media | 1/300 (0.3%) | 0/300 (0%) | ||
| Otitis media acute | 5/300 (1.7%) | 6/300 (2%) | ||
| Otorrhoea | 1/300 (0.3%) | 0/300 (0%) | ||
| Eye disorders | ||||
| Conjunctivitis | 3/300 (1%) | 2/300 (0.7%) | ||
| Gastrointestinal disorders | ||||
| Diarrhoea | 41/300 (13.7%) | 30/300 (10%) | ||
| Gastroenteritis | 12/300 (4%) | 6/300 (2%) | ||
| Vomiting | 8/300 (2.7%) | 7/300 (2.3%) | ||
| General disorders | ||||
| Irritability | 1/300 (0.3%) | 2/300 (0.7%) | ||
| Lethargy | 2/300 (0.7%) | 0/300 (0%) | ||
| Pyrexia | 5/300 (1.7%) | 8/300 (2.7%) | ||
| Immune system disorders | ||||
| Allergic respiratory symptoms | 32/300 (10.7%) | 21/300 (7%) | ||
| Infections and infestations | ||||
| Bronchitis | 1/300 (0.3%) | 3/300 (1%) | ||
| Candida infection | 1/300 (0.3%) | 0/300 (0%) | ||
| Conjunctivitis bacterial | 1/300 (0.3%) | 0/300 (0%) | ||
| Ear infection | 0/300 (0%) | 1/300 (0.3%) | ||
| Impetigo | 3/300 (1%) | 0/300 (0%) | ||
| Malaria | 7/300 (2.3%) | 7/300 (2.3%) | ||
| Nasopharyngitis | 6/300 (2%) | 8/300 (2.7%) | ||
| Pharyngitis | 4/300 (1.3%) | 5/300 (1.7%) | ||
| Rhinitis | 61/300 (20.3%) | 55/300 (18.3%) | ||
| Staphylococcal skin infection | 2/300 (0.7%) | 2/300 (0.7%) | ||
| Varicella | 1/300 (0.3%) | 0/300 (0%) | ||
| Impetigo | 2/300 (0.7%) | 0/300 (0%) | ||
| Injury, poisoning and procedural complications | ||||
| Thermal burn | 0/300 (0%) | 1/300 (0.3%) | ||
| Wound | 1/300 (0.3%) | 1/300 (0.3%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Bronchiolitis | 1/300 (0.3%) | 0/300 (0%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Eczema | 1/300 (0.3%) | 0/300 (0%) | ||
| Rash | 1/300 (0.3%) | 0/300 (0%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Jorge Flores |
|---|---|
| Organization | PATH |
| Phone | (202) 822-0033 |
| jeflores@path.org |
Responsible Party:
PATH
ClinicalTrials.gov Identifier:
NCT02286895
Other Study ID Numbers:
- PATH-RVI-PRV-01
First Posted:
Nov 10, 2014
Last Update Posted:
Jan 2, 2019
Last Verified:
Dec 1, 2018