A Phase I study to assess Reactogenicity, safety and immunogenicity of Biological E’s Liquid Hexavalent Vaccine when administered in healthy children of 16 to 24 months.
- Conditions
- Health Condition 1: Z23- Encounter for immunization
- Registration Number
- CTRI/2023/05/052319
- Lead Sponsor
- Biological E.Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 48
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.
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.
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.
o Fever is defined as the endogenous elevation of at least one measured body temperature of = 38?C (= 100.4?F).8
o Subjects 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,
- fever = 40°C (= 104°F) within 48 hours of vaccination n
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Proportion of subjects with solicited adverse reactions. <br/ ><br>2.Proportion of subjects with unsolicited local and systemic adverse events (AEs) <br/ ><br>3.Serious adverse events (SAEs), Medically attended AEs and AEs of special interest, if anyTimepoint: 1. during first 60 minutes of post vaccination observation period and for subsequent 7 consecutive days captured through subject diary. <br/ ><br>2.during the subsequent follow up period till day 28. <br/ ><br>3.during the post vaccination 28 day follow up period.
- Secondary Outcome Measures
Name Time Method Geometric mean concentrations/titres of anti-Diphtheria, anti-Tetanus, anti-wP, anti-HBsAg, anti-PRP, anti-Poliovirus-1, anti-Poliovirus-2 and anti-Poliovirus-3 antibodiesTimepoint: At 28 days from baseline (day 0) after single booster dose.;Geometric mean fold rise (GMFR) for anti-Diphtheria, anti-Tetanus, anti-wPertussis, anti-HBsAg, anti-PRP and serotype specific (anti-Poliovirus-1, anti-Poliovirus-2 and anti-Poliovirus-3) anti-Polio antibody concentrations/titresTimepoint: At 28 days from baseline (day 0) after single booster dose.;Proportion of subjects seroconverted or seroprotected with anti-Diphtheria, anti-Tetanus, anti-wPertussis, anti-HBsAg, anti-PRP and anti-Poliovirus-1, anti-Poliovirus-2 and anti-Poliovirus-3 antibodiesTimepoint: At 28 days from baseline (day 0) after single booster dose