Immune Response to Rotavirus Vaccine After a Supplemental Dose Given at 9 Months of Age With Local EPI Vaccines in Mali
Condition: Diarrhea Rotavirus
MeSH terms: Diarrhea
Intervention: pentavalent rotavirus vaccine (PRV); measles vaccine (MV); yellow fever vaccine (YFV); meningitis conjugate vaccine (PsA-TT-5μg)
Intervention description: 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.; 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.; 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.; 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.
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 600.0
Sex: All
Minimum age: 9 Months
Maximum age: 11 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: rotavirus; rotavirus vaccine; Mali; EPI vaccines

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.
    

Eligibility criteria:

        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.