Clinical Immunology
Conditions
Interventions
As the study was Non Comparative so only test vaccine was given to the subjects and no control was used
Sponsors
Bio Med Private Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: healthy adult human volunteers above 18 years of age were recruited.
Exclusion criteria
Exclusion criteria: volunteers suffering from fever,Diarrhoea ,infections and those with history of disease,previous administration ofmeningococcal vaccine,drug intake(except vitamins and immunosuppressants in past two weeks of vaccination date),hypersensitivity to any other component of vaccine were excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of Reactivity of Meningococcal Polysaccharide Vaccine (Group A, C, Y and W135)in adult human subjects. Adverse reaction and temperature shall be recorded after 30 minutes, between 4 and 6 hours and again between 24 and 48 hours after injection. Injection site reaction - pain, erythema, inflammation or any other adverse reaction shall be recorded. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of Immunogenicity of Meningococcal Polysaccharide Vaccine (Group A, C, Y and W135)in adult human subjects. Evaluation of antibody titer by bactericidal assay. | — |
Countries
Japan,Asia(except Japan),North America,South America,Australia,Europe,Africa
Contacts
Public ContactDr. Puneet Garg
Bio Med Private Limited Research and Development
Outcome results
None listed