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 28 & Day 56 3. Route of administration: intramuscular injection 4. Total durati
Sponsors
Biological E.Limited
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 and return for follow-up visits). 2. Written or thumb printed informed consent (including audio-visual recording of consent process) obtained from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure. 3. A male or female healthy infant of either gender between 6-8 weeks of age at the time of 1st dose of study vaccination. 4. Healthy infants with body weight = 3300 gms at the time of 1st dose of study vaccination 5. Good clinical condition established by medical history and physical examination (with no acute disease, infection or high temperature) as judged by the principal investigator. 6. Subjects not participating in any other clinical trials. 7. Infants without contraindications or precautionary circumstances for participating in the trial. 8.Infants with a minimal vaccination status for their age at the time of enrolment (“minimal ? defined as single dose of BCG, Hepatitis B birth dose &/or Polio vaccine at the time of enrolment).
Exclusion criteria
Exclusion criteria: 1.Child in care. 2. Use of any investigational or non-registered product (drug or vaccine) during the period starting 30 days before the administration of study vaccine (Day - 29 to Day 0), or planned use during the study period other than the study vaccine. 3. Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe (eg., coagulation abnormalities). 4. Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs or any blood products during the period starting 30 days prior to the proposed first study vaccine dose or planned administration of the same during the study period. 5. Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device). 6. Family history of congenital or hereditary immunodeficiency. 7. History of allergic disease or history of a serious reaction to any prior vaccination or known hypersensitivity likely to be exacerbated by any component of the study vaccines. 8. History of any neurological disorders, meningitis or seizures. 9. Infant who has had a sibling die of sudden infant death syndrome (SIDS) or die suddenly and without apparent other cause or preceding illness in the first year of life. 10. Infant is a direct descendant (child or grand-child) of any person employed by the Sponsor, the Contract Research Organization (CRO) or the Study Site (including the PI and study site personnel). 11. Acute disease and/or fever at the time of vaccination. o Fever is defined as the endogenous elevation of at least one measured body temperature of = 38?C (= 100.4?F). 12. Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination and Principal investigator judgement. 13. Any criteria, which in the judgement of the Investigator, suggests that the subject would not be compliant with the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Proportion of subjects with solicited adverse reactions 2. Proportion of subjects with unsolicited adverse events (AEs) 3.Proportion of subjects with medically attended adverse events (MAAEs) & serious adverse events (SAEs)Timepoint: 1. during first 30 minutes of post vaccination observation period & for subsequent 7 consecutive days (Day 0-6) for any solicited adverse events captured through subject diary 2.during the follow up period until day 84 of post vaccination. 3.during the 84 days follow up period. | — |
Secondary
| Measure | Time frame |
|---|---|
| NoneTimepoint: None | — |
Countries
India
Contacts
Public ContactMr Subba ReddyGV
Biological E.Limited
Outcome results
None listed