A clinical trial to know about effects of 15-valent pneumococcal conjugate vaccine in healthy infants given with routine pediatric vaccinations.

Phase 3

• Registration Number: CTRI/2021/04/032693
• Lead Sponsor: Tergene Biotech Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified