Health Condition 1: Z23- Encounter for immunization
Conditions
Interventions
Intervention1: BE s Meningococcal Conjugate Vaccine (adjuvanted): Each 0.5 mL dose of the vaccine administered intramuscularly, preferably in the deltoid muscle on Day 0
Intervention2: BE s Meningoco
Sponsors
Biological E.Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy male and non-pregnant female subjects between 18-45 (both inclusive) years of age at the time of vaccination; 2. Subject, in the opinion of the investigator, has ability to communicate 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 landline or mobile). 3. Written or thumb printed informed consent (including audio-visual recording of consent process) obtained from the subject prior to performing any study specific procedure. 4. Subjects considered of stable health as judged by the principal investigator based on personal medical history, protocol specific laboratory parameters and clinical examination findings before entering into the study. 5. Negative urine pregnancy test for female subjects of childbearing potential at screening 6.Female participants of non-childbearing potential. 7. No clinically significant abnormal laboratory parameters at baseline as judged by the investigator. 8. Subjects willing to avoid consumption (ingestion) of chronic herbal medication during the course of the study.
Exclusion criteria
Exclusion criteria: 1. Individuals with body temperature greater than or equal to 100.4 F within 3 days of intended study vaccine administration; 2. History of any meningococcal vaccine administration and/or disease caused by N. meningitides; 3. Household contact with and or intimate exposure to N. meningitides infections over the last 90 days; 4. Individuals with any progressive unstable or uncontrolled clinical conditions according to judgment of the investigator (e.g., neurological, neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease); 5. Subject inability to understand and follow required study procedures, keep appointments, or are planning to relocate during the study period; 6. Individuals with history of any illness or any laboratory abnormality that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study; 7.Subject with suspected or known history of an autoimmune disorder or any other known or suspected impairment /alteration of the immune system, or under immunosuppressive therapy including use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids in the previous 30 days; 8. Subject with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time or history of receipt of anti-coagulants in the past 3 weeks; 9. Subjects that have received immunoglobulins and/or any other blood products in the 90 days preceding the vaccination visit 10. History of allergy, hypersensitivity or allergic reaction to any vaccine-related component; 11. Individuals participating in any other clinical trial within 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study; 12. Any other reason that in the opinion of the investigator may interfere with the evaluation required by the study objectives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Proportion of subjects with solicited local and systemic adverse reactions 2. Proportion of subjects with unsolicited local and systemic adverse events (AEs) 3. Serious adverse events (SAEs) and medically attended adverse events (MAAE) if any,Timepoint: 1. during first 60 minutes of post vaccination observation period and for subsequent 7 consecutive days 2. during the total post vaccination follow up period till day 28. 3. during the total study period of 28 days post-vaccination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of subjects achieving a greater than or equal to 4-fold increase in serum bactericidal activity titres for Meningococcal Polysaccharide A, C, Y, W, and X specific antibodiesTimepoint: At day 28 compared to baseline after a single dose vaccination.;Percentage of subjects achieving greater than or equal to 1:8 SBA titres for Meningococcal Polysaccharide A, C, Y, W, and X specific antibodiesTimepoint: at 28 days post single dose vaccination;Meningococcal Polysaccharide A, C, Y, W, and X specific SBA GMTsTimepoint: at day 28 post single dose vaccination;Geometric Mean Fold Rise (GMFR) in Meningococcal Polysaccharide A, C, Y, W, and X specific GMTsTimepoint: at day 28 post single dose vaccination from baseline | — |
Countries
India
Contacts
Public ContactMr Subba Reddy GV
Biological E.Limited
Outcome results
None listed