Diarrhea RotavirusPhase 4NCT02286895
Immune Response to Rotavirus Vaccine After a Supplemental Dose Given at 9 Months of Age With Local EPI Vaccines in Mali
A Phase 4 study testing pentavalent rotavirus vaccine (PRV), measles vaccine (MV) and yellow fever vaccine (YFV) in people with Diarrhea Rotavirus, run by PATH at 1 site in Mali.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 11 monthsHealthy volunteers can take part
- Conditions the study is for
- Diarrhea Rotavirus
- What is being tested?
- pentavalent rotavirus vaccine (PRV), measles vaccine (MV) and yellow fever vaccine (YFV)
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteMali
- Study dates
- Oct 2014to Mar 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 11 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Diarrhea Rotavirus
- Being tested
- pentavalent rotavirus vaccine (PRV), measles vaccine (MV), yellow fever vaccine (YFV), meningitis conjugate vaccine (PsA-TT-5μg)
- Keywords
- rotavirus, rotavirus vaccine, Mali, EPI vaccines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pentavalent rotavirus vaccine (PRV)Biological
Also called RotaTeq
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.
measles vaccine (MV)Biological
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.
yellow fever vaccine (YFV)Biological
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.
meningitis conjugate vaccine (PsA-TT-5μg)Biological
Also called PsA-TT
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A (without rotavirus vaccine) | Active comparator | Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg). Receives: Biological: measles vaccine (MV); Biological: yellow fever vaccine (YFV); Biological: meningitis conjugate vaccine (PsA-TT-5μg) |
| Group B (with rotavirus vaccine) | Experimental | 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). Receives: Biological: pentavalent rotavirus vaccine (PRV); Biological: measles vaccine (MV); Biological: yellow fever vaccine (YFV); Biological: meningitis conjugate vaccine (PsA-TT-5μg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number/Percentage of Subjects With Seroconversion for Anti-measles Immunoglobulin G (IgG) Antibody
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
Measured: 28 days post-vaccination
Number/Percentage of Subjects With Seroresponses for Yellow Fever Neutralizing Antibody
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.
Measured: 28 days post-vaccination
Secondary outcomes (17)
Number/Percentage of Subjects With Seroconversion for Anti-measles Immunoglobulin G (IgG) Antibody
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.
Measured: 3 months post-vaccination
Serum Neutralization Geometric Mean Titers for Yellow Fever Vaccine
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.
Measured: 28 days post-vaccination
Number/Percentage of Subjects With Seroresponses for Meningitis Conjugate Serum Bactericidal Antibody (SBA)
Seroresponse was defined as a geometric mean titer (GMT) of at least four times baseline value. Measured using baby rabbit complement (rSBA).
Measured: 28 days post-vaccination
Geometric Mean of Meningitis Serum Bactericidal Antibody Titer
Measured using baby rabbit complement (rSBA).
Measured: Baseline to Day 28
Number/Percentage of Subjects With Anti-rotavirus Immunoglobulin A (IgA) Titer at Least 3 Times Baseline Value
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.
Measured: 28 days post-vaccination
Number/Percentage of Subjects With Anti-rotavirus IgA Titer of ≥20 Units/mL
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.
Measured: 28 days post-vaccination
Number/Percentage of Subjects With Anti-rotavirus IgA <20 Units/mL at Baseline Visit That Had >=20 Units/mL at Day 28
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.
Measured: 28 days post-vaccination
Number/Percentage of Subjects With Anti-rotavirus IgG Titer at Least 3 Times Baseline Value
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.
Measured: 28 days post-vaccination
Number/Percentage of Subjects With Anti-rotavirus IgG Titer of ≥20 Units/mL
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.
Measured: 28 days post-vaccination
Number/Percentage of Subjects With Anti-rotavirus IgG <20 Units/mL at Baseline Visit That Had >=20 Units/mL at Day 28
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.
Measured: 28 days post-vaccination
Geometric Mean of Anti-rotavirus IgA Concentration
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.
Measured: 28 days post-vaccination
Geometric Mean of Anti-rotavirus IgG Concentration
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.
Measured: 28 days post-vaccination
Geometric Mean of Anti-rotavirus IgA Among Subjects With <20 Units/mL Concentration at Baseline
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.
Measured: 28 days post-vaccination
Geometric Mean of Anti-rotavirus IgG Among Subjects With <20 Units/mL Concentration at Baseline
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.
Measured: 28 days post-vaccination
Number/Percentage of Participants Experiencing Immediate Reactions Post-vaccination
With emphasis on allergic reactions, observed by study staff
Measured: Within 30 minutes post-vaccination
Number of Solicited Adverse Reactions (AR) Experienced by Participants
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.
Measured: 7 days post-vaccination
Number/Percentage of Participants Experiencing Serious Adverse Events (SAE)
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.
Measured: 3 months post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diarrhea RotavirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Vaccine Development - Mali, University of Maryland
- Responsible party
- Sponsor
- Investigators
- Samba O Sow, MD, Msc, Principal investigator, Center for Vaccine Development - Mali
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02286895
- Sponsor's protocol ID
- PATH-RVI-PRV-01
- Status last verified
- Dec 2018
- First submitted
- 1 Oct 2014
- Last updated
- 2 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Haidara FC, Tapia MD, Sow SO, Doumbia M, Coulibaly F, Diallo F, Traore A, Kodio M, Kelly CL, Fitzpatrick M, Kotloff K, Victor JC, Neuzil K. Evaluation of a Booster Dose of Pentavalent Rotavirus Vaccine Coadministered With Measles, Yellow Fever, and Meningitis A Vaccines in 9-Month-Old Malian Infants. J Infect Dis. 2018 Jul 13;218(4):606-613. doi: 10.1093/infdis/jiy215.
PubMed 29659924
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02286895
- Acronym / sponsor ID
- PATH-RVI-PRV-01
- Conditions
- Diarrhea Rotavirus
- Keywords
- rotavirus, rotavirus vaccine, Mali, EPI vaccines
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- PATHUniversity, hospital or other
- Collaborators
- Center for Vaccine Development - Mali, University of Maryland
- Study start
- Oct 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 10 Nov 2014 (estimated)
- Results
- Posted 7 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (without rotavirus vaccine) | Active comparator | Biological: measles vaccine (MV), Biological: yellow fever vaccine (YFV), Biological: meningitis conjugate vaccine (PsA-TT-5μg)Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg). |
| Group B (with rotavirus vaccine) | Experimental | Biological: pentavalent rotavirus vaccine (PRV), Biological: measles vaccine (MV), Biological: yellow fever vaccine (YFV), Biological: meningitis conjugate vaccine (PsA-TT-5μg)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). |
Who may qualify
- Ages
- 9 to 11 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pentavalent rotavirus vaccine (PRV)Also: RotaTeqEach 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. | Biological | Group B (with rotavirus vaccine) |
| 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 | Group A (without rotavirus vaccine), Group B (with rotavirus vaccine) |
| 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 | Group A (without rotavirus vaccine), Group B (with rotavirus vaccine) |
| meningitis conjugate vaccine (PsA-TT-5μg)Also: PsA-TTA 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. | Biological | Group A (without rotavirus vaccine), Group B (with rotavirus vaccine) |
Primary outcome
Number/Percentage of Subjects With Seroconversion for Anti-measles Immunoglobulin G (IgG) Antibody
Time frame: 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
Time frame: 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.
17 secondary outcomes
Number/Percentage of Subjects With Seroconversion for Anti-measles Immunoglobulin G (IgG) Antibody
Time frame: 3 months post-vaccination
Serum Neutralization Geometric Mean Titers for Yellow Fever Vaccine
Time frame: 28 days post-vaccination
Number/Percentage of Subjects With Seroresponses for Meningitis Conjugate Serum Bactericidal Antibody (SBA)
Time frame: 28 days post-vaccination
Geometric Mean of Meningitis Serum Bactericidal Antibody Titer
Time frame: Baseline to Day 28
Number/Percentage of Subjects With Anti-rotavirus Immunoglobulin A (IgA) Titer at Least 3 Times Baseline Value
Time frame: 28 days post-vaccination
Number/Percentage of Subjects With Anti-rotavirus IgA Titer of ≥20 Units/mL
Time frame: 28 days post-vaccination
Number/Percentage of Subjects With Anti-rotavirus IgA <20 Units/mL at Baseline Visit That Had >=20 Units/mL at Day 28
Time frame: 28 days post-vaccination
Number/Percentage of Subjects With Anti-rotavirus IgG Titer at Least 3 Times Baseline Value
Time frame: 28 days post-vaccination
Number/Percentage of Subjects With Anti-rotavirus IgG Titer of ≥20 Units/mL
Time frame: 28 days post-vaccination
Number/Percentage of Subjects With Anti-rotavirus IgG <20 Units/mL at Baseline Visit That Had >=20 Units/mL at Day 28
Time frame: 28 days post-vaccination
Geometric Mean of Anti-rotavirus IgA Concentration
Time frame: 28 days post-vaccination
Geometric Mean of Anti-rotavirus IgG Concentration
Time frame: 28 days post-vaccination
Geometric Mean of Anti-rotavirus IgA Among Subjects With <20 Units/mL Concentration at Baseline
Time frame: 28 days post-vaccination
Geometric Mean of Anti-rotavirus IgG Among Subjects With <20 Units/mL Concentration at Baseline
Time frame: 28 days post-vaccination
Number/Percentage of Participants Experiencing Immediate Reactions Post-vaccination
Time frame: Within 30 minutes post-vaccination
Number of Solicited Adverse Reactions (AR) Experienced by Participants
Time frame: 7 days post-vaccination
Number/Percentage of Participants Experiencing Serious Adverse Events (SAE)
Time frame: 3 months post-vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29659924Haidara FC, Tapia MD, Sow SO, Doumbia M, Coulibaly F, Diallo F, Traore A, Kodio M, Kelly CL, Fitzpatrick M, Kotloff K, Victor JC, Neuzil K. Evaluation of a Booster Dose of Pentavalent Rotavirus Vaccine Coadministered With Measles, Yellow Fever, and Meningitis A Vaccines in 9-Month-Old Malian Infants. J Infect Dis. 2018 Jul 13;218(4):606-613. doi: 10.1093/infdis/jiy215.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samba O Sow, MD, Msc principal investigator
Center for Vaccine Development - Mali
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing pentavalent rotavirus vaccine (PRV), measles vaccine (MV) and yellow fever vaccine (YFV) in people with Diarrhea Rotavirus, run by PATH at 1 site in Mali.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mali. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number/Percentage of Subjects With Seroconversion for Anti-measles Immunoglobulin G (IgG) Antibody (time frame: 28 days post-vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02286895, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2019.