Health Condition 1: Z23- Encounter for immunization
Conditions
Interventions
Intervention1: Biological Es Hepatitis-B vaccine.: 1. Doses: Three doses, 0.5mL per single dose 2. Frequency: Day 0, Day 42 & Day 98 3. Route of administration: intramuscular injection 4. Total durati
Sponsors
Biological ELimited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects’ parent(s)/ LAR(s) who, in the opinion of the investigator, can and will comply, with the requirements of the protocol (e.g., willing for audio-visual recording of consent process, completion of the diary cards, return for follow-up visits and willingness to allow blood sampling). 2. Written or thumb printed informed consent obtained from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure. 3. A male or female child, of less than 24 hours of age at the time of vaccination, without prior immunization of Hepatitis-B vaccine (Birth dose) 4. Born full-term (i.e. after a gestation period of at least 37 weeks) with a birth weight of no less than 2500 grams (i.e., =2500 gms). 5. Mother seronegative (laboratory confirmed) for HBsAg prior to birth of the child. 6. Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion criteria
Exclusion criteria: 1. Child in care. [A child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation. The definition of a child in care can include a child cared for by foster parents or living in a care home or institution, provided that the arrangement falls within the definition above. The definition of a child in care does not include a child who is adopted or has an appointed legal guardian.] 2. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine during the first 24 hour period from birth, before the administration of study vaccine or planned use during the study period. 3. Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe. 4. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). 5. Prior immunization with Hepatitis-B vaccine birth dose with the exception of BCG &/or oral/injectable polio vaccine. 6. Planned administration of immunoglobulins and/or any blood products before the administration of study vaccine or during the study period. 7. Family history of congenital or hereditary immunodeficiency. 8. Major congenital defects (defined as major malformations causing significant functional or cosmetic impairment or being life ?limiting). 9. Acute illness and/or fever at the time of vaccination. Fever is defined as the endogenous elevation of at least one measured body temperature of = 38?C (= 100.4?F). 10. Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination. 11. Administration of long-acting immune-modifying drugs at any time during the study period. 12. Planned or elective surgery during the course of the study. 13. 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.In subjects who are not seroprotected (10 mIU/ml) at baseline, number and percentage of subjects with anti-HBs IgG antibody concentration equal to or above the seroprotection cut-off value 2. In subjects who are already seroprotected (=10 mIU/ml) at baseline, number and percentage of subjects achieving =4-fold increase in anti-HBs IgG antibody concentration.Timepoint: 1.= at day 126 post first dose. 2. from baseline 28 days after 3rd dose of vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Geometric mean Concentrations (GMCs)Timepoint: once at screening before first dose of vaccination and again at Day 126;Occurrence of each solicited local and general symptoms (any and Grade 3). Timepoint: within 7 days ;Occurrence of SAEsTimepoint: from vaccination up to end of study (Visit 4).;Proportion of subjects achieving =4-fold increase and their geometric mean fold increase (GMFR) in anti-HBs IgG antibody concentrationTimepoint: at day 126 post first dose | — |
Countries
India
Contacts
Public ContactDrTSA Kishore
Biological E.Limited
Outcome results
None listed