A clinical trial to know about effects of 15-valent pneumococcal conjugate vaccine in healthy infants given in a Reduced Dosing Schedule with Routine Pediatric Vaccinations.
- Registration Number
- CTRI/2022/10/046401
- Lead Sponsor
- Tergene Biotech Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Subjects will be considered eligible for the study based on the following criteria:
1. Able to follow all the study requirements and 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
Subjects will be excluded from the study based on the following 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). Local anesthetic cream may be applied before blood draws.
8. History of cytotoxic therapy, inhaled corticosteroids (not including allergic rhinitis corticosteroid spray treatment, acute uncomplicated dermatitis surfaces corticosteroid therapy). Topical and inhaled corticosteroids may be permitted as per PIâ??s discretion.
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 Erbâ??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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of subjects achieving WHO-predefined serotype-specific antibody threshold (Greater than or equal to 0.35 microgram per ml). <br/ ><br>serotype-specific IgG GMC ratio <br/ ><br> <br/ ><br>Timepoint: 28 days after completion of 2nd Dose <br/ ><br>
- Secondary Outcome Measures
Name Time Method Ratio of the post-booster value to the post-primary value for the IgG GMCs, <br/ ><br>Serotype-specific Reverse Cumulative Distribution (RCD) plots for IgG. <br/ ><br>Safety Endpoints: Percentage of subjects reporting pre-specified local reactions. <br/ ><br>Percentage of subjects reporting pre-specified systemic events <br/ ><br> <br/ ><br>Timepoint: 28 days after completion of 2nd Dose & 28 days after booster dose. <br/ ><br>Safety Time points Th the study roughout