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

Phase 4

Completed

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

• Registration Number: NCT01457547
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-10
• Primary Completion: 2005-05
• Study Completion: 2005-05
• Study First Submitted: 2011-10-13
• Study First Submitted QC: 2011-10-20
• Study First Posted: 2011-10-24
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-04
• Last Update Posted: 2016-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 494

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DTPa 1 Group	DTPa-HBV-IPV/Hib Vaccine (INFANRIX™ HEXA)	-
DTPa 2 Group	DTPa-HBV-IPV-Hib vaccine (HEXAVAC™)	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

GSK Investigational Site; 🇸🇪 Örebro, Sweden