None listed
Conditions
Interventions
Intervention1: 15-Valent Pneumococcal Conjugate Vaccine (adsorbed): A single dose (0.5 ml) IM injection
Control Intervention1: 13-valent Pneumococcal Conjugate Vaccine from Pfizer (Prevenar13®): A si
Sponsors
Tergene Biotech Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy Subjects of either gender between 2 to 5 years of age (both inclusive). 2. Subjects having no clinically significant findings on physical examination. 3. Eligibility for the study would be determined by medical history, physical examination and PIâ??s clinical judgment. 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 subjectsâ?? parent/s or legal guardian must be able to understand and provide the informed consent. In case they are not literate, an Impartial Witness can sign the ICF if the subjectsâ?? parent/s or legal guardian understand and are willing to allow their ward to participate in the study. 6. Available for the entire study period and willing to adhere to protocol requirements as evidenced by written informed consent.
Exclusion criteria
Exclusion criteria: 1. Previously received vaccination with licensed or investigational pneumococcal vaccine. 2. Received any vaccine within 30 days before the study vaccine (except influenza vaccine). 3. 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. 4. Receipt of diphtheria or diphtheria-containing vaccine within 6 months before study vaccine administration or anticipated receipt of diphtheria-containing vaccine before study completion. 5. History of S. pneumoniae infections. 6. Known hypersensitivity to any component of the vaccine, including diphtheria toxoid. 7. Subjects with history of thrombocytopenia or any coagulation disorder, or those receiving anticoagulant therapy. 8. Subjects with acute disease at the time of enrollment, defined as â??presence of a moderate or severe illness with or without feverâ?? (axillary temperature >= 38°C). 9. Receipt of oral or injected antibiotic therapy within 72 hours prior to any blood draw. 10. Subjects with any sign or symptom of systemic dysfunction, especially of the central nervous system. 11. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Counts and Percentage of Participants Reporting Pre-Specified Local reactions 2. Counts and Percentage of Participants Reporting Pre-Specified Systemic Events 3. Serious adverse events (SAEs), if any,Timepoint: 1. Duration: 7 consecutive days (Day 0-6) post vaccination. 2. Duration: 28 days post vaccination. 3. Duration: 28 days post vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of subjects achieving WHO-predefined serotype-specific antibody threshold â?¥ 0.35μg/mL at EOS. 2. Serotype-specific IgG geometric mean titers (GMT) at EOS.Timepoint: 1. Duration: 28 days post vaccination. 2. Duration: 28 days post vaccination. | — |
Countries
India
Contacts
Public ContactDr Arani Chatterjee
Aurobindo Pharma Ltd.
Outcome results
None listed