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

NCT01457547 | Completed Phase 4

• 1 other identifier: 217744/094
• Study Type: interventional
• Target: 494
• Locations: 3 countries
• Sites: 9

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.

Conditions

Hepatitis B; Poliomyelitis; Diphtheria; Acellular Pertussis; Tetanus; Haemophilus Influenzae Type b

Keywords

HEXAVACTM; InfanrixTM HEXA; DTPa-HBV-IPV-Hib; DTPa-HBV-IPV/Hib

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Study Arms (2)

DTPa 1 Group

EXPERIMENTAL

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

DTPa 2 Group

ACTIVE COMPARATOR

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

Interventions

DTPa-HBV-IPV/Hib Vaccine (INFANRIX™ HEXA) BIOLOGICAL

Three doses administered intramuscularly

DTPa 1 Group

DTPa-HBV-IPV-Hib vaccine (HEXAVAC™) BIOLOGICAL

Three doses administered intramuscularly

DTPa 2 Group

Eligibility Criteria

• Age: 8 Weeks - 15 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (9)

GSK Investigational Site

Helsinki, 00300, Finland

Location

GSK Investigational Site

Bari, Apulia, 70124, Italy

Location

GSK Investigational Site

Galatina (LE), Apulia, 73013, Italy

Location

GSK Investigational Site

Maglie (LE), Apulia, 73024, Italy

Location

GSK Investigational Site

Bologna, Emilia-Romagna, 40138, Italy

Location

GSK Investigational Site

Pavia, Lombardy, 27100, Italy

Location

GSK Investigational Site

Sassari, Sardinia, 07100, Italy

Location

GSK Investigational Site

Linköping, SE-581 85, Sweden

Location

GSK Investigational Site

Örebro, SE-701 85, Sweden

Location

Related Publications (3)

• 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.

  BACKGROUND

• 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.

  PMID: 18690013 BACKGROUND

• 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.

  PMID: 22349525 BACKGROUND

Related 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.

MeSH Terms

Conditions

Hepatitis B; Poliomyelitis; Diphtheria; Tetanus; Haemophilus Infections

Interventions

Hexavac

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Myelitis; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases; Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Clostridium Infections; Pasteurellaceae Infections; Gram-Negative Bacterial Infections

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2011
• First Posted: October 24, 2011
• Study Start: October 1, 2003
• Primary Completion: May 1, 2005
• Study Completion: May 1, 2005
• Last Updated: August 5, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will share

Locations

FI (1); IT (6); SE (2)