NCT00877357

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 7, 2009

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

May 6, 2009

Status Verified

April 1, 2009

Enrollment Period

3.9 years

First QC Date

April 6, 2009

Last Update Submit

May 5, 2009

Conditions

DiphtheriaTetanusPertussisHepatitis BHaemophilus Influenzae Type B

Keywords

VaccinePreventionDiphtheriaTetanusPertussisHepatitis BHaemophilus influenzae type bLot ConsistencyLong Term ImmunogenicityReactogenicityHealthy infants

Outcome Measures

Primary Outcomes (1)

  • Solicited and unsolicited local and systemic adverse events following vaccination

    4 Months

Secondary Outcomes (2)

  • 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

Study Arms (3)

Shan 5 Lot No 1

EXPERIMENTAL
Biological: Shan 5

Shan 5 Lot No 2

EXPERIMENTAL
Biological: Shan 5

Shan 5 Lot No 3

EXPERIMENTAL
Biological: Shan 5

Interventions

Shan 5BIOLOGICAL

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

Shan 5 Lot No 1Shan 5 Lot No 2Shan 5 Lot No 3

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 (hepatitis B surface antigen) assured negative.
  • Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Public Health, Post Graduate Institute of Medical Education and Research

Chandigarh, Uttarakhand, 160012, India

RECRUITING

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

    STUDY DIRECTOR

Central Study Contacts

Mandeep S Dhingra, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 6, 2009

First Posted

April 7, 2009

Study Start

January 1, 2009

Primary Completion

December 1, 2012

Study Completion

February 1, 2013

Last Updated

May 6, 2009

Record last verified: 2009-04

Locations

IN(1)