None listed
Conditions
Interventions
Intervention1: 15 Valent Pneumococcal Conjugate Vaccine: The study will consist of single center single dose. Eligible Subjects will be Injected the 15-Valent Pneumococcal Conjugate Vaccine
Control In
Sponsors
Tergene Biotech Pvt Ltd A Joint Venture of Aurobindo Pharma Ltd
Axis Clinicals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy subjects between 18 to 45 years of age both inclusive 2. Subjects having no clinically significant findings on physical examination and clinical laboratory tests 3. Eligibility for the study would be determined by medical history physical examination screening laboratory tests and PIs clinical judgment Subjects with preexisting stable disease defined as disease not requiring significant change in therapy or hospitalization for worsening disease within 12 weeks before receipt of study vaccine are eligible 4. Subjects not currently participating in any other clinical trials and not having a plan of taking additional pneumococcal vaccines licensed or investigational as well as other non-study vaccines throughout study duration 5. The subject must be able to understand and provide the ICF If subject is not literate an Impartial Witness can sign the ICF if the subject understands and is willing to participate in the study 6. Subject must be available for the entire study period and willing to adhere to protocol requirements as evidenced by written ICF 7. Subjects must have negative test results for HIV 1 2 HCV and HBsAg
Exclusion criteria
Exclusion criteria: 1. Incapable of understanding the ICF 2. Previous vaccination with licensed or investigational pneumococcal vaccine 3. Received any vaccine within 30 days before the study vaccine except influenza vaccine 4. Females who are pregnant breastfeeding or planning a pregnancy or who are of childbearing potential and not using a reliable method of contraception throughout study duration 5. Receipt of blood products or gamma globulin including Hepatitis B immunoglobulin and any monoclonal antibody within 6 months before study vaccination or anticipated receipt of such before study completion 6. Receipt of diphtheria or diphtheria-containing vaccine within 6 months before study vaccine administration or anticipated receipt of diphtheria-containing vaccine before study completion 7. History of any S. pneumoniae infections 8. Known hypersensitivity to any component of the vaccine, including diphtheria toxoid 9. Subjects with thrombocytopenia or any coagulation disorder or to those receiving anticoagulant therapy 10. Subjects with an acute or chronic condition eg metastatic malignancy severe chronic obstructive pulmonary disease requiring supplemental oxygen end stage renal disease with or without dialysis clinically unstable cardiac disease that in the Investigators opinion would limit the subjects ability to complete or participate in this clinical trial 11. Subjects with acute disease at the time of enrollment defined as presence of a moderate or severe illness with or without fever Oral temperature 38°C 12. Subjects with a history of Splenectomy 13. Subjects with known/suspected immunosuppressive or immunodeficient condition, or receiving immunosuppressive therapy Subjects having received systemic corticosteroids for short term treatment of acute illness would be eligible to receive vaccine 1 month after discontinuation of corticosteroid therapy 14. Subjects with any sign or symptom of systemic dysfunction especially of the central nervous system CNS 15. Any criteria which in the opinion of the Investigator, suggests that the subject would not be compliant with the study protocol or would confound the result of the study 16. Subjects unable to receive vaccination in the deltoid muscle of either arm due to low muscle mass
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Tolerability Endpoints â?¢ Counts and Percentage of Participants Reporting PreSpecified Local reactions within 7 days after dose â?¢ Counts and Percentage of Participants Reporting PreSpecified Systemic Events within 28 days after dose Timepoint: Safety and Tolerability Endpoints â?¢ Counts and Percentage of Participants Reporting PreSpecified Local reactions within 7 days after dose â?¢ Counts and Percentage of Participants Reporting PreSpecified Systemic Events within 28 days after dose | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Percentage of subjects achieving WHO-predefined serotypespecific antibody threshold â?¥ 0.35μg/mL at EOS The serotype-specific IgG geometric mean titers GMT at EOS Timepoint: Not applicable | — |
Countries
India
Contacts
Public ContactDrSubhra Lahiri
AXIS Clinicals Limited
Outcome results
None listed