None listed
Conditions
Sponsors
PANACEA BIOTEC LIMITED
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy male or female Subjects aged 18 to 65 years of age. 2.Subjects with normal health as determined by personal medical history, clinical examination and past laboratory examinations (within the clinically acceptable normal range) done during screening. 3.Subject willing to give written informed consent and fulfill all study requirements 4.If female subjects and child bearing potential but practicing acceptable method of contraception or surgically sterile. Acceptable methods of contraception are Intra-uterine contraceptive device without hormone release system placed at least 4weeks prior to study drug administration Effective method of barrier contraception like Condom or diaphragm with spermicidal gel/foam/film/cream/suppository
Exclusion criteria
Exclusion criteria: 1. History of previous vaccination against S. pneumoniae (in the previous 5 years). 2. History of pneumococcal infection (confirmed either clinically, serologically, or microbiologically) within 5 years 3. Bleeding disorder, including thrombocytopenia contraindicating IM vaccination, or receipt of anticoagulants in the 3 weeks preceding inclusion. 4. Investigator site personnel directly affiliated with this study and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted. 5. Known Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the study vaccine or a vaccine with similar composition. 6. Known history of administration of blood or blood-derived products in the past 3 months. 7. Chronic administration (defined as more than 14 days) of high doses of corticosteroids, cytotoxic agents or radiotherapy or immunoglobulins, lmmunosuppressants or other immune-modifying drugs in past or at any time during the study. 8. Febrile illness (temperature >=38.0°C or 100.4 °F) or moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination. 9. Receipt of oral or injected antibiotic therapy within 72 hours prior to any blood draw (for immunogenicity assessment). 10. Use of any investigational drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. 11. Presence of chronic cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder, cancer or autoimmune disease under treatment such as would endanger the volunteer or is likely to result in non conformance to the protocol. 12. Current alcohol abuse or drug addiction that may interfere with the subjects ability to comply with trial procedures 13. History or presence of significant asthma, urticaria or other allergic reactions. 14. History or presence of significant smoking (more than 10 cigarettes or beedis/day). 15. Pregnant and/ or lactating mothers in case of female subjects. 16. Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C seropositivity 17. Participation in a drug research study within past 3 months. 18. Planned participation in another clinical trial during the trial period. 19. Subjects planning to leave the area of study before completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety tolerability Incidence intensity causality and relationship to vaccination of solicited adverse eventsTimepoint: solicited adverse events local and systemic during the 7 day follow-up period day 0 to 7 after vaccination, 4 weeks follow-up period after vaccination Incidence, intensity, causality and relationship to vaccination of Serious Adverse Events (SAEs) during the entire study period | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity- serotype specific Anti Pneumococcal IgG as determined by ELISA and OPATimepoint: Seroprotection against Pneumococcal Serotypes at 28+3 days followup post vaccination | — |
Countries
India
Contacts
Public ContactArani Chatterjee
Panacea biotec ltd
Outcome results
None listed