Clinical trial NCT01457547: Comparison of Immunogenicity and Reactogenicity of INFANRIX™ HEXA and HEXAVAC™ Vaccines as a Primary Vaccination Course
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis B
Poliomyelitis
Diphtheria
Acellular Pertussis
Tetanus
Haemophilus Influenzae Type b
Keywords: HEXAVACTM
InfanrixTM HEXA
DTPa-HBV-IPV-Hib
DTPa-HBV-IPV/Hib
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-10-24
Enrollment: 494
Sex: ALL
Minimum age (years): 8
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Immunogenicity with respect to the components of the study vaccine in terms of antibody concentrations
timeFrame: Prior to the third primary vaccination dose ( Months 8-9)
Secondary outcomes:
measure: Immunogenicity with respect to the components of the study vaccine in terms of antibody concentrations
timeFrame: One month after the second and third primary vaccination dose (Month 3 and Months 9-10)
measure: Immunogenicity with respect to the components of the study vaccine in terms of number of seroprotected subjects defined by antibody concentration
timeFrame: Prior to and one month after the third primary vaccination dose ( Months 8-9 and Months 9-10)
measure: Immunogenicity with respect to the components of the study vaccine in terms of number of seropositive subjects
timeFrame: Prior to and one month after the third primary vaccination dose ( Months 8-9 and Months 9-10)
measure: Occurrence of solicited symptoms
timeFrame: Within 4 days (Day 0 -Day 3) after each vaccine dose
measure: Occurrence of a grade "3" solicited symptoms
timeFrame: Within 4 days (Day 0 -Day 3) after each vaccine dose
measure: Occurrence of unsolicited adverse events
timeFrame: Within 31 days after any vaccination
measure: Occurrence of Serious Adverse Events
timeFrame: Throughout the entire study up to (Month 0 to Month 9-10) and including 30 days after last vaccination (Month 9-10)
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: GSK Investigational Site
city: Bologna
country: Italy
facility: GSK Investigational Site
state: Emilia-Romagna
city: Pavia
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Bari
country: Italy
facility: GSK Investigational Site
state: Puglia
city: Galatina (LE)
country: Italy
facility: GSK Investigational Site
state: Puglia
city: Maglie (LE)
country: Italy
facility: GSK Investigational Site
state: Puglia
city: Sassari
country: Italy
facility: GSK Investigational Site
state: Sardegna
city: Linköping
country: Sweden
facility: GSK Investigational Site
city: Örebro
country: Sweden
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.