Safety and Immunogenicity Study of a Liquid Pentavalent Combination Vaccine

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and immunogenicity of an indigenously developed liquid pentavalent (diphtheria, tetanus, pertussis, hepatitis B and Hib) combination vaccine in healthy Indian infants as a part of the routine immunization in accordance with the EPI schedule.

Official Title
-----------------
An Open Label Multicentric Study to Evaluate the Immunogenicity and Safety of Indigenously Developed DTPwHB-Hib (Liquid) Pentavalent Combination Vaccine (Shan 5) in Indian Infants.

Conditions
-----------------
Diphtheria, Tetanus, Pertussis, Hepatitis B, Haemophilus Influenzae Type B

Intervention / Treatment
-----------------
* Biological: Shan5


Participation Criteria
=================
Eligibility Criteria
-----------------
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. 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 Infants showing any of the following reactions after any dose of study vaccine will be withdrawn for subsequent doses: body temperature more than 40.4 degree Celsius, persistent screaming or crying for 3 hours within 48 hours of vaccination, seizures,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

Ages Eligible for Study
-----------------
Minimum Age: 6 Weeks
Maximum Age: 8 Weeks

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shan5<br> | Biological: Shan5<br>* Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib tetanus toxoid conjugate pentavalent liquid combination vaccine<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroprotection rates for Diphtheria, Tetanus, Pertussis, Hepatitis B and Hib following 3 doses of the vaccine. |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Solicited and unsolicited local and systemic adverse events following vaccination |  | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vaccine, Prevention, Diphtheria, Tetanus, Pertussis, Hepatitis B, Haemophilus influenzae type b, Healthy infants