Health Condition 1: Z23- Encounter for immunization
Conditions
Interventions
Intervention1: BE s MR Vaccine (Investigational): Single dose- 0.5 ml by subcutaneous injection to be administered subcutaneously on day 0.
Duration:
6 months post single dose of vaccine administr
Sponsors
Biological E.Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy male or female infants between 9-12 months of age at the time of the vaccination; 2. Subjects parent(s)/ LAR(s) who, in the opinion of the investigator, can and will comply, with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits, with access to a consistent means of telephone contact, either residential land line or mobile). 3. Written or thumb printed informed consent (including audio-visual recording of consent process) obtained from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure. 4. Good clinical condition established by medical history and physical examination (with no acute disease, infection or high temperature) as judged by the principal investigator 5. Subjects not participating in any other clinical trials.
Exclusion criteria
Exclusion criteria: 1. Subject had a history of previous measles or rubella infection or Measles Rubella containing vaccination. 2. Family history of any hypersensitivity reactions to Measles, MR or MMR vaccination(s) or allergy to any of their components. 3. Child in care, defined as a child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation. 4. Acute disease and/or fever at the time of vaccination. 5. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine during the period starting 30 days before the administration of study vaccine or planned use during the study period. 6. Any medical condition that in the judgment of the investigator would make subcutaneous injection unsafe. 7. Known or suspected allergy to any of the vaccine components. History of allergic disease or history of a serious reaction to any prior vaccination or known hypersensitivity likely to be exacerbated by any component of the study vaccines. 8. Any sign or symptom or systemic dysfunction, especially of the central nervous system (CNS) 9. Known family history of SIDS (Sudden Infant Death Syndrome). 10. Planned or elective surgery during the course of the study. 11. Infants with a known or suspected impairment of the immune function (congenital or hereditary), or those receiving immunosuppressive therapy, or received immunosuppressive therapy prior to study entry (including systemic or high doses of inhaled corticosteroids) or those who have received a parenteral immunoglobulin preparation 12. Infants who have received any blood products, cytotoxic agents, corticosteroids or radiotherapy 13. Subjects who have participated in another clinical trial of an investigational agent within last 30 days or likely to participate during the study course. 14. Inability or unwillingness of the subject s parent/LAR to abide by the requirements of the protocol. 15. Subjects with congenital abnormalities. 16. Administration of immunoglobulins and/or any blood products during the period starting three months before the administration of study vaccine or planned administration during the study period. 17. Administration of long-acting immune-modifying drugs at any time during the study period. 18. Any criteria, which in the judgement of the Investigator, suggests that the subject would not be compliant with the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At Phase II: 1. Number and proportion of subjects with solicited local and systemic adverse events 2.Number and proportion of subjects with solicited local adverse events and systemic adverse events 3. Number and proportion of subjects with unsolicited adverse events 4. Number and proportion of subjects with any serious adverse events (SAEs)or AEs SAEs At Phase III: Proportion of subjects seropositive with anti-Measles IgG antibodies and anti-Rubella IgG antibodies. Timepoint: At Phase II: 1. First 60 minutes of post vaccination observation period. 2. 7 consecutive days and for systemic adverse events during 14 days post vaccination. 3. 14 days post vaccination 4. 14 days post vaccination. At Phase III: 1. 42 days post vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| At Phase III: Number & proportion of subjects with solicited local & systemic adverse eventsTimepoint: At Phase III: 60 minutes of post vaccination observation period;Number & proportion of subjects with solicited local adverse events & and systemic adverse eventsTimepoint: 7 days & systemic adverse events during 14 days post vaccination;Number & proportion of subjects with unsolicited adverse events (AEs)Timepoint: 42 days post vaccination.;Number & proportion of subjects with Medically attended adverse events (MAAEs), & serious adverse events (SAEs), if any,Timepoint: 42 days post vaccination.;Geometric mean concentrations/titres (GMCs/GMTs) of anti-Measles IgG and anti-Rubella IgG antibodiesTimepoint: estimated both at baseline and again at day 42.;Geometric mean fold rise (GMFR) for anti-measles IgG & anti-Rubella IgG antibody concentrations/titresTimepoint: 42 days from baseline i.e Day 0.;Number & proportion of subjects seropositive with anti-Measles & anti-rubella antibodiesTimepoint: 42 days post vaccination;Number & proportion of subjects with unsolicited AEs, MAAEs, & SAEsTimepoint: 6 months follow up period after the vaccination | — |
Countries
India
Contacts
Public ContactMr Subba Reddy GV
Biological E.Limited
Outcome results
None listed