Safety and Immunogenicity Study of a Liquid Pentavalent Combination Vaccine

Shantha Biotechnics

Status and phase

Completed

Phase 4

Conditions

Diphtheria

Haemophilus Influenzae Type B

Hepatitis B

Pertussis

Tetanus

Treatments

Biological: Shan5

Study type

Interventional

Funder types

Industry

Identifiers

NCT00617812

SBL/DTPwHB-Hib/PMS/2007/0100

Details and patient eligibility

About

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.

Enrollment

160 patients

Sex

All

Ages

6 to 8 weeks old

Volunteers

Accepts Healthy Volunteers

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Infants showing any of the following reactions after any dose of study vaccine will be withdrawn for subsequent doses: body temperature more than 40.4 degree Celsius, persistent screaming or crying for 3 hours within 48 hours of vaccination, seizures,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