A Prospective Randomised Phase-I study to evaluate the Safety, Reactogenicity & Immunogenicity of single booster dose of Biological E’s Liquid Hexavalent Vaccine (DTwP-rHepB-Hib-IPV) in 16-24 months old healthy toddlers. - None

Biological E.Limited0 sites48 target enrollmentTBD

ConditionsHealth Condition 1: Z23- Encounter for immunization

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Health Condition 1: Z23- Encounter for immunization
Sponsor: Biological E.Limited
Enrollment: 48
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

TBD

End Date

September 11, 2023

Last Updated

last year

Study Type

Interventional

Investigators

Sponsor

Biological E.Limited

Eligibility 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. completion of the diary cards, return for follow\-up visits).
•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 between and including 16 and 24 months of age at the time of vaccination.
•4\. Healthy subjects as established by medical history and clinical examination before entering into the study.
•5\. Documented routine childhood vaccinations, with at least complete primary vaccination for D, T, (wP or aP), HepB, Hib and polio as per national recommendation and have not received the booster dose scheduled at 15 to 18 months of age.
•6\. Born full\-term (i.e. after a gestation period of at least 37 weeks).
•7\. Subjects that are negative for Human Immunodeficiency Virus (HIV), hepatitis B and hepatitis C to the best of parent(s)/LAR(s) knowledge.

Exclusion Criteria

•1\. Child in care.
•2\. 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.
•3\. Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
•4\. 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.
•5\. Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the administration of study vaccine (Day \-29 to Day 0\), or planned use during the study period.
•6\. 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).
•7\. Evidence of previous or intercurrent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and/or H. influenzae type b diseases.
•8\. Known exposure to diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and/or H. influenzae type b diseases.
•9\. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
•10\. Family history of congenital or hereditary immunodeficiency.