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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00877357

Enrollment

3000

Registered

2009-04-07

Start date

2009-01-31

Completion date

2013-02-28

Last updated

2009-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Vaccine, Prevention, Diphtheria, Tetanus, Pertussis, Hepatitis B, Haemophilus influenzae type b, Lot Consistency, Long Term Immunogenicity, Reactogenicity, Healthy infants

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.

Interventions

BIOLOGICALShan 5

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Weeks to 8 Weeks

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Solicited and unsolicited local and systemic adverse events following vaccination	4 Months

Secondary

Measure	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

Countries

India

Contacts

Primary ContactMandeep S Dhingra, MD

drmandeep@shanthabiotech.co.in+91-40-66301000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026