Ivermectin 12 mg / day for 3 days, in combination with paracetamol therapy (500 mg QID) for 14 days

Ivermectin placebo 12 mg / day for 3 days, in combination with paracetamol therapy (500 mg QID) for 14 days

COVID-19

ivermectin 12 mg / day for 3 days, in combination with standard paracetamol therapy (500 mg QID) for 14 days

Ivermectin

Placebo of ivermectin 12 mg / day for 3 days, in combination with standard paracetamol therapy (500 mg QID) for 14 days

Placebo

Stromectol. FDA Approved Package Insert 2009

Efficacy, Safety and Tolerability of Ivermectin in Subjects Infected With SARS-CoV-2 With or Without Symptoms

Multicenter, Double-blind, Randomized, Placebo-controlled Study to Assess the Efficacy, Safety and Tolerability of Ivermectin in Mild Virus-positive Subjects (SARS-CoV)-2 With or Without Symptoms

The subject is considered to have progressed to severe illness when one or more of the following criteria are present:
Breathing difficulty (≥30 breaths per minute);
Resting oxygen saturation ≤93%;
Severe complications such as: respiratory failure, need for mechanical ventilation, septic shock, non-respiratory organic failure.

Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.

Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and 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).

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 (Without 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).
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

Group B (With Rotavirus Vaccine)

Total

Age, Customized

Sex: Female, Male

Region of Enrollment

Ethnicity

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 Seroconversion for Anti-measles Immunoglobulin G (IgG) 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.

Number/Percentage of Subjects With Seroresponses for Yellow Fever Neutralizing 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 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.

Serum Neutralization Geometric Mean Titers for Yellow Fever Vaccine

Seroresponse was defined as a geometric mean titer (GMT) of at least four times baseline value. Measured using baby rabbit complement (rSBA).

Number/Percentage of Subjects With Seroresponses for Meningitis Conjugate Serum Bactericidal Antibody (SBA)

Measured using baby rabbit complement (rSBA).

Geometric Mean of Meningitis Serum Bactericidal Antibody Titer

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 Immunoglobulin A (IgA) Titer at Least 3 Times Baseline Value

Number/Percentage of Subjects With Anti-rotavirus IgA Titer of ≥20 Units/mL

Number/Percentage of Subjects With Anti-rotavirus IgA <20 Units/mL at Baseline Visit That Had >=20 Units/mL at Day 28

Number/Percentage of Subjects With Anti-rotavirus IgG Titer at Least 3 Times Baseline Value

Number/Percentage of Subjects With Anti-rotavirus IgG Titer of ≥20 Units/mL

Number/Percentage of Subjects With Anti-rotavirus IgG <20 Units/mL at Baseline Visit That Had >=20 Units/mL at Day 28

Geometric Mean of Anti-rotavirus IgA Concentration

Geometric Mean of Anti-rotavirus IgG Concentration

Geometric Mean of Anti-rotavirus IgA Among Subjects With <20 Units/mL Concentration at Baseline

Geometric Mean of Anti-rotavirus IgG Among Subjects With <20 Units/mL Concentration at Baseline

With emphasis on allergic reactions, observed by study staff

Number/Percentage of Participants Experiencing Immediate Reactions 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 of Solicited Adverse Reactions (AR) Experienced by Participants

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.

Number/Percentage of Participants Experiencing Serious Adverse Events (SAE)

Randomized and Vaccinated

Assessed for Measles Seroconversion

Jorge Flores

Diarrhea Rotavirus

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.

pentavalent rotavirus vaccine (PRV)

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.

measles vaccine (MV)

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.

yellow fever vaccine (YFV)

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.

meningitis conjugate vaccine (PsA-TT-5μg)

CVD-Mali

Immune Response to Rotavirus Vaccine After a Supplemental Dose Given at 9 Months of Age With Local EPI Vaccines in Mali

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

yellow fever/שלשול

Efficacy, Safety and Tolerability of Ivermectin in Subjects Infected With SARS-CoV-2 With or Without Symptoms

Immune Response to Rotavirus Vaccine After a Supplemental Dose Given at 9 Months of Age With Local EPI Vaccines in Mali

המאגר השלם ביותר של צמחי מרפא המגובה על ידי המדע