None listed
Conditions
Interventions
Intervention1: 15-Valent Pneumococcal conjugate vaccine: A single dose (0.5 ml) IM injection
Control Intervention1: 13-Valent Pneumococcal conjugate vaccine (Prevnar 13�®): A single dose (0.5 ml) IM
Sponsors
Tergene Biotech Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Voluntarily obtained informed consent from Parent/ legal guardian/LAR of the infant. 2. Infant aged 6-10 weeks (42-69 days) at enrollment. 3. Healthy infant as determined by medical history, physical exam, and judgment of the investigator. 4. Parent/ legal guardian/ LAR must be able to complete all relevant study procedures during study participation.
Exclusion criteria
Exclusion criteria: 1. Subject with administration history of pneumococcal vaccine 2. Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis or rotavirus vaccines 3. Known hypersensitivity or anaphylactic reaction to any vaccine or vaccine-related component 4. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, hepatitis B, rotavirus or pneumococcal vaccines 5. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection 6. Known or suspected immune deficiency or suppression 7. Receipt of blood or gamma-globulin products (including hepatitis B immunoglobulin and monoclonal antibodies) 8. History of cytotoxic therapy, inhaled corticosteroids (not including allergic rhinitis corticosteroid spray treatment, acute uncomplicated dermatitis surfaces corticosteroid therapy) 9. History of culture-proven invasive disease caused by S. pneumoniae or H. influenzae type b (Hib) 10. Any congenital malformation, developmental disorder, genetic defects or severe malnutrition 11. Significant neurological disorder or history of seizure, including febrile seizure, or significant stable or evolving disorders, such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders. Does not include resolving syndromes due to birth trauma such as Erbââ?¬•s palsy. 12. Participation in another investigational trial. Participation in purely observational studies is acceptable. 13. Any co-existing condition which in the opinion of investigator may interfere with the study participation 14. Direct descendant (i.e. child, grandchild) of study site personnel 15. Infants with known Coronavirus infection (COVID-19)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of subjects achieving WHO-predefined serotype-specific antibody threshold (Greater than or equal to 0.35 microgram per ml) at End of study (EOS). The serotype-specific IgG GMC ratios of serotypes common Proportions that achieve Greater than or equal to 0.35 microgram per ml against each serotype (contained only in the new vaccine; IgG GMC ratios for serotypes found only in the new vaccine Timepoint: 28 days after completion of 3rd Dose | — |
Secondary
| Measure | Time frame |
|---|---|
| For the serotypes common to the new vaccine and the licensed comparator Serotype-specific Reverse Cumulative Distribution (RCD) plots for IgG. For serotypes found only in the new vaccine RCD plots for serotypes found only in the new vaccine. Safety Endpoints: Percentage of subjects reporting Pre-specified local reactions Percentage of subjects reporting Pre-specified systemic events Timepoint: 28 days after completion of 3rd Dose 7 consecutive days (Day 0-6) post vaccination | — |
Countries
India
Contacts
Public ContactMr K Sathyan
Aurobindo Pharma Ltd.
Outcome results
None listed