None listed
Conditions
Interventions
SIIL): 0.5 mL IM, non-dominant upper arm, single administration
Control Intervention1: 23-valent Pneumococcal Polysaccharide Vaccine (Pneumovax® 23
Merck): 0.5 mL IM, non-dominant upper arm, single administration
Sponsors
Serum Institute of India Limited
Eligibility
Inclusion criteria
Inclusion criteria: Healthy young Indian adults between 18 to 40 (inclusive) years of age. Note: â??Healthyâ?? being those without acute or chronic, clinically significant pulmonary, cardiovascular, hepatobiliary, gastrointestinal, renal, neurological, mental or hematological functional abnormality or illness that requires medical therapy, as determined by medical history or clinical assessment before entering the study. Subjects who provide voluntary written informed consent to participate in the study and are capable of comprehending and complying with study requirements and procedures, able and willing to complete subject diary and to return for all scheduled follow-up visits, and have expressed availability for the required study period, with access to a consistent means of telephone contact, either residential land line or mobile. Adult male subjects willing to follow acceptable methods of contraception (e.g. condom, with or without spermicide) or practice abstinence and agreeing not to make their female partners pregnant from the time of vaccination until the end of the study. Adult female subjects who are not surgically sterile must have a negative serum pregnancy test on enrolment and prior to vaccination, and will be advised through the informed consent process to avoid becoming pregnant over the duration of the study, and must agree to employ an effective form of birth control for the duration of the study. Note: Acceptable forms of birth control are: credible history of continuous abstinence from heterosexual activity, hormonal contraceptive (oral, injectable, implant, patch, or ring), double-barrier contraceptives (condom or diaphragm, either with spermicide) and IUD. When using contraceptives, subjects must have been using their current contraceptive for the past 3 months to be eligible. Women with documented sterilization via tubal ligation or hysterectomy or having surgically sterilized male partners may be enrolled and are not subject to pregnancy testing. Subjects willing to avoid consumption (ingestion) of chronic herbal medication during the course of the study.
Exclusion criteria
Exclusion criteria: Use of any investigational or non-registered drug within 90 days prior to the administration of study vaccine or planned during the course of study participation. History of previous vaccination against Streptococcus pneumoniae or recent history of Streptococcus pneumoniae infection in the past 2 years. History of administration of any non-study vaccine within 30 days prior to administration of study vaccine or planned vaccination during the course of study participation. History of allergic disease or history of a serious reaction to any prior vaccination or known hypersensitivity to any component of the study vaccines. History of anaphylactic shock. Acute illness (moderate or severe) and/or fever (oral temperature 38°C). Receipt of antibiotics (oral or injected) from 5 days before screening through to randomization. Immunosuppression or immunodeficiency (inclusive of HIV, Hep B, Hep C) as shown by serological examination at screening. Disorders that require chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs within the past 6 months prior to the administration of the study vaccine. An immunosuppressant dose of glucocorticoid will be defined as a systemic dose 10 mg of prednisone per day. The use of topical glucocorticoids will be permitted. Administration of immunoglobulins and/or any blood products within the 6 months preceding enrolment in the study; or anticipation of such administration during the study period. Known disturbance of coagulation or other blood disorder (e.g. thalassemia, thrombocytopenia, disorders of the lymphocytes, anemias, etc) or receipt of anti-coagulants in the past 3 weeks (prn aspirin and NSAIDs are acceptable). History of meningitis or seizures or any neurological disorder or major psychiatric disorder. Acute or chronic, clinically significant pulmonary, cardiovascular, hepatobiliary, gastrointestinal, renal, neurological, or hematological functional abnormality or major congenital defects or illness that requires medical therapy, as determined by medical history or clinical assessment. Any medical or social condition that in the opinion of the investigator will interfere with the study objectives or pose a risk to the study subject or may prevent the subject from completing the study follow up. Suspicion or recent history (within the past year) of alcohol or substance abuse. Female subjects who are pregnant or breast-feeding. An employee (or first degree relative of employee) of the Sponsor, the CRO, or any investigator or site personnel. Any screening laboratory test result outside normal parameters and deemed by the clinician to be clinically significant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Tolerability following IM injection of SIILPCV10 vaccine for occurrence, severity, and relationship to vaccination of solicited, unsolicited Adverse Events and SAEs.Timepoint: Solicited adverse events (local and systemic) during the 7 day follow-up period post vaccination. Unsolicited adverse events during the 28-Day follow-up period post vaccination SAEs during the entire study period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and Tolerability following IM injection of SIILPCV10 vaccine versus Active Comparator for occurrence, severity, and relationship to vaccination of solicited, unsolicited Adverse Events, SAEs and Safety Laboratory parameters (Hematological, Serum Chemistry, Organ Function) which are of clinical significance and related to vaccination.Timepoint: Solicited adverse events (local and systemic) during the 7 day follow-up period post vaccination. Unsolicited adverse events during the 28-Day follow-up period post vaccination. SAEs during the entire study period. Safety Laboratory parameters at day 7. | — |
Countries
India
Contacts
Public ContactDr Vistasp Sethna
Serum Institute of India Limited
Outcome results
None listed