Safety, Long Term Immunogenicity and Lot Consistency Study of Liquid Pentavalent Combination Vaccine

Study Overview
=================
Brief Summary
-----------------
A randomized phase IV study of the liquid pentavalent combination vaccine to evaluate the safety, immunogenicity (short term and long term) and clinical consistency of three production lots of the vaccine.

Official Title
-----------------
Open Label Multicentric Randomized Phase IV Post Marketing Safety, Immunogenicity and Lot-to-Lot Consistency Analysis of Shan 5 [DTPwHB-Hib (Liquid) Pentavalent Combination Vaccine] in Indian Infants

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

Intervention / Treatment
-----------------
* Biological: Shan 5


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 (hepatitis B surface antigen) assured negative. Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form. Exclusion Criteria: Administration of immunoglobulin or any blood products since birth. Use of any investigational, un-registered drug, or vaccine other than the study vaccine (with the exception of oral polio vaccination 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 born to mothers known to be HIV positive. 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 Infants showing any of the following reactions after any dose of study vaccine will be withdrawn for subsequent doses: body temperature more than 40.40C, persistent screaming or crying for 3 hours within 48 hours of vaccination, seizures, encephalopathy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

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shan 5 Lot No 1<br> | Biological: Shan 5<br>* Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib tetanus toxoid conjugate pentavalent liquid combination vaccine<br>|
| Experimental: Shan 5 Lot No 2<br> | Biological: Shan 5<br>* Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib tetanus toxoid conjugate pentavalent liquid combination vaccine<br>|
| Experimental: Shan 5 Lot No 3<br> | Biological: Shan 5<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 |
| --- | --- | --- |
| Solicited and unsolicited local and systemic adverse events following vaccination |  | 4 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroprotection rates for Diphtheria, Tetanus, Pertussis, Hepatitis B and Hib following 3 doses of the vaccine |  | 12 Months | 
| Lot Consistency based on safety and Seroprotection rates for Diphtheria, Tetanus, Pertussis, Hepatitis B and Hib following 3 doses of the vaccine from each of the three lots |  | 4 months | 

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