Diphtheria, Haemophilus Influenzae Type B, Hepatitis B, Pertussis, Tetanus
Conditions
Keywords
Vaccine, Prevention, Diphtheria, Tetanus, Pertussis, Hepatitis B, Haemophilus influenzae type b, Vaccine interchangeability, Single vs mixed sequence, Healthy infants
Brief summary
The objective of this study is to compare the Safety and Immunogenicity of a mixed sequence of 2 different pentavalent vaccines (Diphtheria-Tetanus- Pertussis, Hepatitis B and Hib combination Vaccines) with single sequence of Shan 5 in infants.
Interventions
BIOLOGICALShan 5
Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib tetanus toxoid conjugate pentavalent liquid combination vaccine
BIOLOGICALEasy Five
Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib conjugate pentavalent liquid combination vaccine
Sponsors
Shantha Biotechnics Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 8 Weeks
Healthy volunteers
Yes
Inclusion criteria
* Healthy children in the age group six to eight weeks * Born after a normal gestational period (36 - 42 weeks) * Mother's HBsAg assured negative. * Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form. * Parents willing to fill the Diary Card
Exclusion criteria
* Administration of immunoglobulin or any blood products since birth. * Use of any investigational, on-registered drug, or vaccine other than the study vaccine (with the exception of OPV & BCG vaccine) during the study period or within 30 days preceding the first dose of the study vaccine. * Previous vaccination or evidence of infection with DTP or Hib. * History of allergic disease or reaction likely to be exacerbated by any component of the vaccine including allergy to antibiotics. * Major congenital or hereditary immunodeficiency. * Infants having evidence of disease or fever, history of allergic disease or persistent hematological, hepatic, renal, cardiac or respiratory disease and signs of a CNS disorder at the time of vaccination. * Infants showing any of the following reactions after any dose of study vaccine will be withdrawn for subsequent doses: body temperature more than 40.4 degree Celsius, persistent screaming or crying for 3 hours within 48 hours of vaccination, seizures, encephalopathy and hypersensitivity reaction. * Parent/s or guardian of subject unable to maintain diary card * Simultaneous participation in any other clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seroprotection rates for Diphtheria, Tetanus, Pertussis, Hepatitis B and Hib following 3 doses of the vaccines in a single and mixed sequence regimen. | 4 months |
Secondary
| Measure | Time frame |
|---|---|
| Solicited and unsolicited local and systemic adverse events following vaccination | 4 months |
Countries
India
Outcome results
None listed