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Clinical Trials/NCT01457547
NCT01457547CompletedPhase 4

Study to Assess and Compare the Immunogenicity and Reactogenicity of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (INFANRIX™ HEXA) and Aventis Pasteur MSD's DTPa-HBV-IPV-Hib Vaccine (HEXAVAC™) Given at 3, 5 and 11-12 Months of Age

GlaxoSmithKline9 sites in 3 countries494 target enrollmentStarted: October 1, 2003Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
494
Locations
9
Primary Endpoint
Immunogenicity with respect to the components of the study vaccine in terms of antibody concentrations
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The study will compare the immunogenicity and the reactogenicity of INFANRIX™ HEXA and HEXAVAC™ vaccines in a 3, 5 and 11 - 12 month vaccination schedule.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Participant)

Eligibility Criteria

Ages
8 Weeks to 15 Weeks (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •A healthy male or female subject between 8 and 15 weeks of age at the time of the first vaccination.
  • •Written informed consent obtained from the parent or guardian of the subject prior to the study entry.
  • •Free of obvious health problems as established by medical history and clinical examination before entering into the study.
  • •Born after a normal gestation period between 36 and 42 weeks.

Exclusion Criteria

  • •Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the administration of the study vaccine, or planned use during the study period.
  • •Evidence of previous or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B and/or Hib vaccination or disease.
  • •Planned administration of a vaccine not foreseen by the study protocol since birth and during the period starting 30 days before the administration of the first dose and ending 30 days after the last dose of the three-dose primary vaccination course, with the exception of licensed Neisseria meningitides conjugate vaccines or Bacillus Calmette-Guérin (BCG) vaccine that can be given in between study visits or after the third visit, provided they are given preferably with a 4 weeks interval but not less than 3 weeks apart from the study vaccine doses.
  • •Chronic administration or planned administration of immuno-suppressants or other immune-modifying drugs since birth.
  • •Planned administration of immunoglobulins and/or any blood products since birth or planned administration during the period up to 30 days after the third dose of the primary vaccination course.
  • •Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
  • •History of seizures, progressive neurological disease or intra-cerebral haemorrhage.
  • •Major congenital defects or serious chronic illness.
  • •Acute febrile illness at the time of planned vaccination
  • •History of allergic disease or reactions likely to be exacerbated by any component of the study vaccine.

Arms & Interventions

DTPa 1 Group

Experimental

Intervention: DTPa-HBV-IPV/Hib Vaccine (INFANRIX™ HEXA) (Biological)

DTPa 2 Group

Active Comparator

Intervention: DTPa-HBV-IPV-Hib vaccine (HEXAVAC™) (Biological)

Outcomes

Primary Outcomes

Immunogenicity with respect to the components of the study vaccine in terms of antibody concentrations

Time Frame: Prior to the third primary vaccination dose ( Months 8-9)

Secondary Outcomes

  • Immunogenicity with respect to the components of the study vaccine in terms of antibody concentrations(One month after the second and third primary vaccination dose (Month 3 and Months 9-10))
  • Immunogenicity with respect to the components of the study vaccine in terms of number of seroprotected subjects defined by antibody concentration(Prior to and one month after the third primary vaccination dose ( Months 8-9 and Months 9-10))
  • Immunogenicity with respect to the components of the study vaccine in terms of number of seropositive subjects(Prior to and one month after the third primary vaccination dose ( Months 8-9 and Months 9-10))
  • Occurrence of solicited symptoms(Within 4 days (Day 0 -Day 3) after each vaccine dose)
  • Occurrence of a grade "3" solicited symptoms(Within 4 days (Day 0 -Day 3) after each vaccine dose)
  • Occurrence of unsolicited adverse events(Within 31 days after any vaccination)
  • Occurrence of Serious Adverse Events(Throughout the entire study up to (Month 0 to Month 9-10) and including 30 days after last vaccination (Month 9-10))

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (9)

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