A clinical study to assess the safety and immune response with two doses of Hepatitis A vaccine of BE when compared with a licensed vaccine in 1-15 year-old healthy children.
- Conditions
- Health Condition 1: Z23- Encounter for immunization
- Registration Number
- CTRI/2019/04/018384
- Lead Sponsor
- Biological ELimited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 520
1. Subjects whose parent(s)/ LAR(s), in the opinion of the investigator, can and will comply, with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits,with access to a consistent means of telephone contact, either residential landline or mobile).
2. Written or thumb printed informed consent (including audio-visual recording of consent process) obtained from the subject’s parent(s)/LAR(s) of the subject prior to performing any study specific procedure. An assent will also be obtained for children and
adolescents (=10 years to =15 years of age) where applicable prior to screening.
3. A male or female Hepatitis A vaccine-naïve children between one year and including to 15 years of age at the time of first dose
vaccination. Hepatitis A vaccine-naïve children are those who have not been previously vaccinated with any licensed or investigational Hepatitis A Vaccine.
4. Children with an up-to-date minimal vaccination status for their age at the time of enrolment (minimal ? is defined as single dose of
BCG, 3 doses of OPV, DPT, Hepatitis B, HIB and single dose of Measles at the time of enrolment).
5. Healthy subjects as judged by the principal investigator based on medical history and clinical examination before entering into the
study.
6. Subjects that are negative for Human Immunodeficiency Virus (HIV), hepatitis B and hepatitis C to the best of parent(s)/LAR(s)
knowledge.
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. Previous history of Hepatitis A vaccination;
3. Evidence of previous or intercurrent Hepatitis A infection.
4. Use of any investigational or non-registered product (drug or vaccine) other than the study 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.
5. Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
6. Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the first vaccine dose. For
corticosteroids, this will mean prednisone = 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
7. 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).
8. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
9. Family history of congenital or hereditary immunodeficiency.
10. 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.
11. Major congenital defects as judged by the PI.
12. History of any neurological disorders, meningitis or seizures.
13. Children who 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.
14. Children 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).
15. 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).
16. Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical
examination.
17. Administration of immunoglobulins and/or any blood products during the period starting three months before the administration of study vaccine or planned administration during the study period.
18. Administration of long-acting immune-modifying drugs at any time during the study period.
19. Occurrence of any of the following adverse events after a previous administration of a diphtheria-tetanus-pertussis vaccine:
- collapse or shock-like state (hypotonic-hyporesponsive episode)
within 48 hours of vacc
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Proportion of subjects achieving seroconversion (seropositive) ( =20 mIU/mL) with anti-HAV IgG antibodies. <br/ ><br>2. Proportion of subjects achieving =4 fold increase in Anti-HAV antibodies <br/ ><br>3.Proportion of subjects achieving =2 fold increase in Anti-HAV antibody concentration. <br/ ><br>4. Geometric mean concentration (GMC)Timepoint: 1. At Day 210 (30 days after 2nd dose) from baseline. <br/ ><br>2. At Day 210 (30 days after 2nd dose) from baseline. <br/ ><br>3. At Day 210 (30 days after 2nd dose) who were already seroconverted ( =20 mIU/mL) at baseline <br/ ><br>4. At baseline and at Day 210 (30 days after 2nd dose).
- Secondary Outcome Measures
Name Time Method Proportion of subjects with solicited adverse reactions. <br/ ><br>Timepoint: During first 60 minutes of post-vaccination observation period and for subsequent 7 consecutive days (Day 0-6) thereafter. <br/ ><br> <br/ ><br>;Proportion of subjects with unsolicited local and <br/ ><br>systemic adverse events (AEs)Timepoint: During the total post-vaccination follow up period <br/ ><br>till day 210.;Serious adverse events (SAEs), if any,Timepoint: During the total post-vaccination follow up period <br/ ><br>till day 210.