Comparison of Immunogenicity and Reactogenicity of INFANRIX™ HEXA and HEXAVAC™ Vaccines as a Primary Vaccination Course

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

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 Overview

• Status: Completed
• Conditions: Hepatitis B; Tetanus; Diphtheria; Acellular Pertussis; Poliomyelitis; Haemophilus Influenzae Type b
• Intervention / Treatment: Biological: DTPa-HBV-IPV/Hib Vaccine (INFANRIX™ HEXA); Biological: DTPa-HBV-IPV-Hib vaccine (HEXAVAC™)

• Study Type: Interventional
• Enrollment (Actual): 494
• Phase: Phase 4

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland, 00300
    • GSK Investigational Site
• Italy
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40138
      • GSK Investigational Site
  • Lombardia
    • Pavia, Lombardia, Italy, 27100
      • GSK Investigational Site
  • Puglia
    • Bari, Puglia, Italy, 70124
      • GSK Investigational Site
    • Galatina (LE), Puglia, Italy, 73013
      • GSK Investigational Site
    • Maglie (LE), Puglia, Italy, 73024
      • GSK Investigational Site
  • Sardegna
    • Sassari, Sardegna, Italy, 07100
      • GSK Investigational Site
• Sweden
  • Linköping, Sweden, SE-581 85
    • GSK Investigational Site
  • Örebro, Sweden, SE-701 85
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 3 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DTPa 1 Group	Biological: DTPa-HBV-IPV/Hib Vaccine (INFANRIX™ HEXA); Three doses administered intramuscularly
Active Comparator: DTPa 2 Group	Biological: DTPa-HBV-IPV-Hib vaccine (HEXAVAC™); Three doses administered intramuscularly

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Immunogenicity with respect to the components of the study vaccine in terms of antibody concentrations	Prior to the third primary vaccination dose ( Months 8-9)

Secondary Outcome Measures

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• Kilpi et al. Comparison of the immunogenicity and reactogenicity of two hexavalent DTPa-HBV-IPV/Haemophilus influenzae type b vaccines administered at 3, 5 and 11-12 months of age. Abstract presented at the 24th annual meeting of the European Society for Paediatric Infectious Diseases (ESPID), Basel Switzerland 03-05 May, 2006.
• Kilpi TM, Silfverdal SA, Nilsson L, Syrjanen R, Belloni C, Desole M, Triban C, Storsaeter J, Soila M, Jacquet JM. Immunogenicity and reactogenicity of two diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio virus-Haemophilus influenzae type b vaccines administered at 3, 5 and 11-12 months of age. Hum Vaccin. 2009 Jan-Feb;5(1):18-25. doi: 10.4161/hv.5.1.6369. Epub 2009 Jan 2.
• Van Der Meeren O, Kuriyakose S, Kolhe D, Hardt K. Immunogenicity of Infanrix hexa administered at 3, 5 and 11 months of age. Vaccine. 2012 Apr 5;30(17):2710-4. doi: 10.1016/j.vaccine.2012.02.024. Epub 2012 Feb 18.

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start: October 1, 2003
• Primary Completion (Actual): May 1, 2005
• Study Completion (Actual): May 1, 2005

Study Registration Dates

• First Submitted: October 13, 2011
• First Submitted That Met QC Criteria: October 20, 2011
• First Posted (Estimate): October 24, 2011

Study Record Updates

• Last Update Posted (Estimate): August 5, 2016
• Last Update Submitted That Met QC Criteria: August 4, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: DTPa-HBV-IPV/Hib; HEXAVACTM; InfanrixTM HEXA; DTPa-HBV-IPV-Hib
• Additional Relevant MeSH Terms: Digestive System Diseases; Central Nervous System Diseases; Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Neuromuscular Diseases; Central Nervous System Infections; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Enterovirus Infections; Picornaviridae Infections; Spinal Cord Diseases; Corynebacterium Infections; Hepatitis; Myelitis; Hepatitis B; Diphtheria; Poliomyelitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Immunologic Factors; Protective Agents; Anticoagulants; Antidotes; Chelating Agents; Sequestering Agents; Iron Chelating Agents; Calcium Chelating Agents; Vaccines; Edetic Acid; Pentetic Acid
• Other Study ID Numbers: 217744/094

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Dataset Specification
   Information identifier: 217744/094
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Individual Participant Data Set
   Information identifier: 217744/094
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Clinical Study Report
   Information identifier: 217744/094
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Statistical Analysis Plan
   Information identifier: 217744/094
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Study Protocol
   Information identifier: 217744/094
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Informed Consent Form
   Information identifier: 217744/094
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register