Clinical trial NCT00877357: Safety, Long Term Immunogenicity and Lot Consistency Study of Liquid Pentavalent Combination 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diphtheria
Tetanus
Pertussis
Hepatitis B
Haemophilus Influenzae Type B
Keywords: Vaccine
Prevention
Diphtheria
Tetanus
Pertussis
Hepatitis B
Haemophilus influenzae type b
Lot Consistency
Long Term Immunogenicity
Reactogenicity
Healthy infants
Lead sponsor: Shantha Biotechnics Limited
Sponsor class: INDUSTRY
First posted: 2009-04-07
Enrollment: 3000
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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* Infants showing any of the following reactions after any dose of study vaccine will be withdrawn for subsequent doses: body temperature more than 40.40C, persistent screaming or crying for 3 hours within 48 hours of vaccination, seizures, encephalopathy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

Primary outcomes:
measure: Solicited and unsolicited local and systemic adverse events following vaccination
timeFrame: 4 Months
Secondary outcomes:
measure: Seroprotection rates for Diphtheria, Tetanus, Pertussis, Hepatitis B and Hib following 3 doses of the vaccine
timeFrame: 12 Months
measure: 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
timeFrame: 4 months
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: School of Public Health, Post Graduate Institute of Medical Education and Research
state: UT
Study officials:
affiliation: Shantha Biotechnics Limited
name: Raman Rao, MD
role: STUDY_DIRECTOR
References: