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

Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01457547
• Other study ID #: 217744/094
• Status: Completed
• Phase: Phase 4
• First received: October 13, 2011
• Last updated: August 4, 2016
• Start date: October 2003
• Est. completion date: May 2005

Study information

• Verified date: August 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: FIMEA (Finnish Medicines Agency)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 494
• Est. completion date: May 2005
• Est. primary completion date: May 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Weeks to 15 Weeks

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

Biological:
• DTPa-HBV-IPV/Hib Vaccine (INFANRIX™ HEXA)
Three doses administered intramuscularly
• DTPa-HBV-IPV-Hib vaccine (HEXAVAC™)
Three doses administered intramuscularly

Locations

Country	Name	City	State
Finland	GSK Investigational Site	Helsinki
Italy	GSK Investigational Site	Bari	Puglia
Italy	GSK Investigational Site	Bologna	Emilia-Romagna
Italy	GSK Investigational Site	Galatina (LE)	Puglia
Italy	GSK Investigational Site	Maglie (LE)	Puglia
Italy	GSK Investigational Site	Pavia	Lombardia
Italy	GSK Investigational Site	Sassari	Sardegna
Sweden	GSK Investigational Site	Linköping
Sweden	GSK Investigational Site	Örebro

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Finland,  Italy,  Sweden, 

References & 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.

Kilpi TM, Silfverdal SA, Nilsson L, Syrjänen 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. Epub 2009 Jan 2. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	Occurrence of solicited symptoms		Within 4 days (Day 0 -Day 3) after each vaccine dose	No
Secondary	Occurrence of a grade "3" solicited symptoms		Within 4 days (Day 0 -Day 3) after each vaccine dose	No
Secondary	Occurrence of unsolicited adverse events		Within 31 days after any vaccination	No
Secondary	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)	No

External Links

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