Coadministration of Measles-rubella and Rotavirus Vaccines
Condition: Measles Antibody Seroconversion; Rubella Antibody Seroconversion; Rotavirus Geometric Mean Titer (GMT); Rotavirus Immunoglobulin A (IgA) Seropositivity
MeSH terms: Measles; Rubella
Intervention: Rotarix vaccine; measles-rubella vaccine
Intervention description: one 1.0 ml dose of oral rotavirus vaccine at 9 months of age; one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 482.0
Sex: All
Minimum age: 9 Months
Maximum age: 11 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: rotavirus

Summary:

      The investigators aim to establish the non-inferiority of concomitant administration of
      measles-rubella and rotavirus vaccines to measles-rubella vaccine given alone in terms of
      measles seroconversion rates. The primary study hypothesis is the measles seroconversion rate
      as defined by the percentage of children seroconverting to measles with a measles serum
      antibody concentration of >=1:120 at 8 weeks post vaccination after the concomitant
      administration of measles-rubella and rotavirus vaccines is non-inferior to that obtained
      when measles-rubella vaccine is given alone in children 9 months of age who have received a
      primary rotavirus vaccine series with the first dose between 6 and 10 weeks and the second at
      least 4 weeks later and are seronegative for measles antibody in the pre-vaccination sample.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Child 9 months of age eligible for measles-rubella vaccination

          -  documented evidence of a primary rotavirus vaccine series with first dose between 6
             and 10 weeks of age and second dose at least 4 weeks after first dose

          -  healthy infants free of chronic or serious medical condition as determined by history
             and physical examination at time of study enrollment

          -  parents/guardians of each participant are able to understand and follow study
             procedures and agree to participate in study by providing signed informed consent

        Exclusion Criteria:

          -  hypersensitivity to any component of measles-rubella or Rotarix vaccine which would
             preclude administration of the vaccine

          -  history of intussusception, intestinal malformations, or abdominal surgery

          -  known history of measles and/or rubella disease

          -  history of previous receipt of measles and/or rubella vaccine

          -  use of any immunosuppressive drugs or immunoglobulin and/or blood products since birth
             or anticipated during study period

          -  current enrolment in any other intervention trial or use of any investigational drug
             or vaccine throughout the study period

          -  any participant who reports planning to leave the study area before the completion of
             the study

          -  acute diarrhea (defined as ≥3 loose stools within a 24-hour period) or vomiting
             (defined as projectile vomiting or any vomiting at the discretion of the clinician) at
             the time of enrollment or within the last 24 hours

          -  acute febrile illness (defined as a temperature of ≥38°C) at the time of enrollment.