None listed
Conditions
Interventions
Intervention1: Edmonston-Zagreb (E-Z) strain attenuated measles vaccine manufactured by the Serum Institute of India, Ltd (SIIL) - aerosolized using Aerogen Aeroneb Clinical nebulizer.: The single dos
Sponsors
Serum Institute of India Ltd Pune
World Health Organization WHO Switzerland
Eligibility
Inclusion criteria
Inclusion criteria: Age: from 9.00 to 11.99 months on expected vaccination date; Resident in the study area and likely to remain for the duration of the child?s involvement in the study; Parent/guardian willing for child to be randomized and willing for child to be followed up for at least 91 days.
Exclusion criteria
Exclusion criteria: Having received measles, measles-rubella or measles-mumps-rubella vaccine (with confirmation from vaccination card). Any contraindication to measles vaccine administration as stated in the WHO measles vaccine position paper: 42 Persons with a history of an anaphylactic reaction to neomycin, gelatine or other components the vaccine should not be vaccinated. Furthermore, measles vaccine is contraindicated in persons who are severely immunocompromised as a result of congenital disease, HIV infection, advanced leukaemia or lymphoma, serious malignant disease, or treatment with high-dose steroids, alkylating agents or antimetabolites, or in persons who are receiving immunosuppressive therapeutic radiation. Administration of immunoglobulins or other antibody-containing blood products may interfere with the immune response to the vaccine. Vaccination should be delayed for 3?11 months after administration of blood or blood products, depending on the dose of measles antibody. Following measles vaccination, administration of such blood products should be avoided for 2 weeks, if possible. Mild, concurrent infections are not considered a contraindication, and there is no evidence that measles vaccination exacerbates tuberculosis. However, vaccination should be avoided if there is high fever or other signs of serious disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunogenicity: Measles seropositivity at day 91 post-vaccination. Safety: AEs up to and including day 91 post-vaccination; AEs include acute clinical reactogenicity, other AEs, and serious or unexpected AEs. Timepoint: day 91 post-vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| For all infants: GMT, pre-vaccination and at day 91; Seroconversion (defined as a change from Enzygost OD less than 0.1 to OD more than- equal to 0.1 or PRNT from less than 120 to more than- equal to 120 mIU/mL) measured in paired samples from day 0 & day 91; For infants from Vadu in 28 & 364 days subset: GMT at days 28 & 364 to describe evolution of antibody response at days 0, 28, 91, 364 Seropositivity at 364 days in infants with antibody titre more than-equal to 120 mIU/ml at day 91Timepoint: For all infants: day 91 post-vaccination For infants in the day 28 blood sample subset or the day 364 blood sample subset: day 28 and day 364 post-vaccination | — |
Countries
India
Contacts
Public ContactDr Ashish Bavdekar
KEM Hospital Research Centre Pune
Outcome results
None listed