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Status:

COMPLETED

Compare Immunogenicity & Safety of 2 Formulations of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine Given in Healthy Infants

Lead Sponsor:

GlaxoSmithKline

Conditions:

Diphtheria

Hepatitis B

Eligibility:

All Genders

11-17 years

Phase:

PHASE3

Brief Summary

In this study, infants will be randomly allocated into three groups: * one group of subjects will receive DTPa-HBV-IPV/Hib vaccine (new formulation) * the second group of subjects will receive DTPa-H...

Detailed Description

A study to compare the immunogenicity \& safety of 2 formulations of GlaxoSmithKline (GSK) Biologicals' DTPa-HBV-IPV/Hib vaccine given in healthy infants at 3,4 \& 5 months age. The immunogenicity \& ...

Eligibility Criteria

Inclusion

  • "Inclusion criteria:
  • A healthy male or female infant between, and including, 11 and 17 weeks of age at the time of the first vaccination.
  • Infant born to known hepatitis B surface antigen (HBsAg) seronegative mother (documented laboratory result of HBsAg assay from the maternal blood sample is available).
  • Born after a normal gestation period (between 36 and 42 weeks).
  • Written informed consent obtained from the parent or guardian of the subject.
  • Exclusion criteria:
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  • Any chronic drug therapy to be continued during the study period.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccine and ending 30 days after the last vaccine dose.
  • Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and/or Haemophilus influenzae diseases.
  • Known history of or exposure to diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and/or Haemophilus influenzae diseases since birth.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
  • "

Exclusion

    Key Trial Info

    Start Date :

    April 1 2006

    Trial Type :

    INTERVENTIONAL

    End Date :

    January 1 2007

    Estimated Enrollment :

    415 Patients enrolled

    Trial Details

    Trial ID

    NCT00320463

    Start Date

    April 1 2006

    End Date

    January 1 2007

    Last Update

    October 12 2016

    Active Locations (4)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (4 locations)

    1

    GSK Investigational Site

    Murmansk, Russia, 183046

    2

    GSK Investigational Site

    Perm, Russia, 614022

    3

    GSK Investigational Site

    Syktyvkar, Russia, 167002

    4

    GSK Investigational Site

    Syktyvkar, Russia, 167011