Phase IV Interchangeability 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: Shan 5; Biological: Easy Five

Study type: Interventional

Funder types: Industry

Identifiers

NCT00674908

SBL/DTPwHB-Hib/INT/2007/0200

Details and patient eligibility

About

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.

Enrollment: 144 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 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• Infants showing any of the following reactions after any dose of study vaccine will be withdrawn for subsequent doses: body temperature more than 40.4 degree Celsius, persistent screaming or crying for 3 hours within 48 hours of vaccination, seizures,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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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144 participants in 2 patient groups

Shan 5

Experimental group

Description:

Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib tetanus toxoid conjugate pentavalent liquid combination vaccine

Treatment:

Biological: Shan 5

Easy 5

Active Comparator group

Description:

Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib conjugate pentavalent liquid combination vaccine

Treatment:

Biological: Easy Five