Health Condition 1: Z23- Encounter for immunization
Conditions
Interventions
Intervention1: BE’s Liquid Hexavalent (DTwP-rHepB-HIB-IPV) Liquid Vaccine (Test Vaccine) full dose strength of IPV.: Each 0.5 mL will be administered intramuscularly in the anterolateral aspect of mid
Sponsors
Ms Biological E Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Intended subjects will be healthy infants between 6-8 weeks of age, of either gender at the time of 1st vaccination. 2. Written or thumb printed informed consent obtained from the subject’s parent(s) or legally acceptable representative prior to performing any study specific procedure. 3. Healthy infants with weight = 3300gms at the time of 1st vaccination. 4. Good clinical condition established by medical history and physical examination (with no acute disease, infection or high temperature). 5. Subjects and or their mothers not participating in any other clinical trials. 6. Infants without contraindications or precautionary circumstances for participating in the trial. 7. Ability of the subject’s parent or legally acceptable representative or guardian to understand and comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).
Exclusion criteria
Exclusion criteria: 1. Child in care 2. Prior immunization with DTP, Hepatitis-B or HIB vaccine with the exception of birth dose BCG, Hepatitis B & oral polio vaccine. 3. Co-administration of any oral or injectable polio vaccine during the course of the study. 4. Current illness (especially fever) or any acute or congenital illness or disability. 5. Evidence of previous or intercurrent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and or H. influenzae type b diseases 6. Subjects receiving immunosuppressive therapy. 7. Known or suspected allergy to any of the vaccine components. 8. Any sign or symptom or systemic dysfunction, especially of the central nervous system (CNS). 9. Known family history of SIDS (Sudden Infant Death Syndrome). 10. Planned or elective surgery during the course of the study. 11. Infants who have received any blood products, any dose of corticosteroids, cytotoxic agents or radiotherapy. 12. Subjects and or their mothers who have participated in another clinical trial of an investigational agent within last 30 days or likely to participate during the study course. 13. Inability or unwillingness to abide by the requirements of the protocol. 14. Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe. 15. Any criteria, which in the opinion of the Investigator, suggests that the subject would not be compliant with the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Solicited local adverse reactions and systemic events 2.Solicited local and systemic adverse events (AEs) 3.Unsolicited adverse events (AEs) 4.Rate of SAEs, medically attended AEs and AEs of special interest (AESI)Timepoint: 1. during first 60 minutes of vaccine administration after each dose 2.during 7-day (Day 0-6) post vaccination period 3.during the subsequent follow up period i.e., 28 days after each dose 4.for the total study period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects seroconverted and or seroprotected with anti-Diphtheria, anti-Tetanus, anti-Pertussis, anti-HBsAg, anti-PRP-T and serotype specific anti-Polio antibodiesTimepoint: At Day 84 (28 days’ post 3rd dose).;Geometric mean concentrations titres (GMC Ts) for anti-Diphtheria, anti-Tetanus, anti-Pertussis, anti-HBsAg, anti-PRP and serotype specific anti-Polio antibody concentrations or titresTimepoint: At baseline and again at Day 84 (28 days’ post 3rd dose) from baseline (day 0).;Proportion of subjects achieving =2-fold and =4-fold rise in anti-Diphtheria, anti-Tetanus, anti-wPertussis, anti-HBsAg, anti-PRP and serotype specific anti-Polio antibody concentrations or titresTimepoint: At Day 84 (28 days’ post 3rd dose) from baseline (day 0);Geometric mean fold rise (GMFR) for anti-Diphtheria, anti-Tetanus, anti-wPertussis, anti-HBsAg, anti-PRP and serotype specific anti-Polio antibody concentrations or titresTimepoint: At Day 84 (28 days’ post 3rd dose) from baseline (day 0). | — |
Countries
India
Contacts
Public ContactMr Subba Reddy GV
Biological E.Limited
Outcome results
None listed