A phase-I clinical study to assess the safety of Biological Es liquid DTwP-rHepB-Hib-IPV vaccine in 16 to 24 months old healthy children.
- Conditions
- Health Condition 1: Z23- Encounter for immunization
- Registration Number
- CTRI/2019/01/016891
- Lead Sponsor
- Biological ELimited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
1. Subjectsâ?? 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.
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.
1. Child in care.
Please refer to the GLOSSARY OF TERMS for the definition of 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 ï?³ 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.
11.History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
12.Major congenital defects.
13.History of any neurological disorders or seizures.
14.Acute disease and/or fever at the time of vaccination.
oFever is defined as the endogenous elevation of at least one measured body temperature of >= 38â?¦C (>= 100.4â?¦F).8
oSubjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
15.Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination.
16.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.
17.Administration of long-acting immune-modifying drugs at any time during the study period.
18.Previous booster vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or H. influenzae diseases.
19.History of non-response to vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or H. influenzae diseases.
20.Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.
21.Occurrence of any of the following adverse events after a previous administration of a diphtheria-tetanus-pertussis vaccine:
- encephalopathy of unknown aetiology occurring within seven days following previous vaccination with pertussis-containing vaccine,
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Occurrence of each solicited local and general symptoms (any and Grade 3). <br/ ><br>2.Occurrence of unsolicited AEs <br/ ><br>3.Occurrence of SAEs from vaccinationTimepoint: 1.within 7 days (Day 0 â?? Day 6) after vaccination. <br/ ><br>2.within 29 days (Day 0 â?? Day 28) after vaccination. <br/ ><br>3.up to study end (Visit 3)
- Secondary Outcome Measures
Name Time Method oneTimepoint: None