NCT00617812

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2008

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 18, 2008

Completed
12 days until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

June 25, 2009

Status Verified

June 1, 2009

Enrollment Period

1.1 years

First QC Date

February 6, 2008

Last Update Submit

June 24, 2009

Conditions

DiphtheriaTetanusPertussisHepatitis BHaemophilus Influenzae Type B

Keywords

VaccinePreventionDiphtheriaTetanusPertussisHepatitis BHaemophilus influenzae type bHealthy infants

Outcome Measures

Primary Outcomes (1)

  • Seroprotection rates for Diphtheria, Tetanus, Pertussis, Hepatitis B and Hib following 3 doses of the vaccine.

    4 months

Secondary Outcomes (1)

  • Solicited and unsolicited local and systemic adverse events following vaccination

    4 months

Study Arms (1)

Shan5

EXPERIMENTAL
Biological: Shan5

Interventions

Shan5BIOLOGICAL

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

Shan5

Eligibility Criteria

Age6 Weeks - 8 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Deccan College of Medical Sciences

Hyderabaad, Andhra Pradesh, 500058, India

Location

Ankur Institute of Child Health

Ahmedabad, Gujarat, 380009, India

Location

JSS Medical College

Mysore, Karnataka, 570015, India

Location

Institute of Child Health

Kolkata, West Bengal, 700017, India

Location

MeSH Terms

Conditions

DiphtheriaTetanusWhooping CoughHepatitis BHaemophilus Infections

Condition Hierarchy (Ancestors)

Corynebacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsClostridium InfectionsBordetella InfectionsGram-Negative Bacterial InfectionsRespiratory Tract InfectionsRespiratory Tract DiseasesBlood-Borne InfectionsCommunicable DiseasesHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System DiseasesPasteurellaceae Infections

Study Officials

  • Raman Rao, MD

    Shantha Biotechnics Limited, Hyderabad, India

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 6, 2008

First Posted

February 18, 2008

Study Start

March 1, 2008

Primary Completion

April 1, 2009

Study Completion

May 1, 2009

Last Updated

June 25, 2009

Record last verified: 2009-06

Locations

IN(4)