Last updated: 11/04/2018 01:12:51
Comparison of immunogenicity and reactogenicity of INFANRIX™ HEXA and HEXAVAC™ vaccines as a primary vaccination course
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:
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:
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)
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)
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)
Occurrence of solicited symptoms
Timeframe: Within 4 days (Day 0 –Day 3) after each vaccine dose
Occurrence of a grade “3” solicited symptoms
Timeframe: Within 4 days (Day 0 –Day 3) after each vaccine dose
Occurrence of unsolicited adverse events
Timeframe: Within 31 days after any vaccination
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)
Interventions:
Enrollment:
494
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical 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 et al. (2009) 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. 5(1):18-25.
Van Der Meeren O et al. (2012) Immunogenicity of Infanrix™ hexa administered at 3, 5 and 11 months of age. Vaccine. 30(17):2710-2714.
Medical condition
Hepatitis B, Poliomyelitis, Diphtheria, acellular pertussis, Tetanus, Haemophilus influenzae type b
Product
SB217744
Collaborators
Not applicable
Study date(s)
October 2003 to May 2005
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
8 - 15 weeks
Accepts healthy volunteers
Yes
- 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.
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
A healthy male or female subject between 8 and 15 weeks of age at the time of the first vaccination.
Exclusion criteria:
- 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.
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.
Trial location(s)
Showing 1 - 6 of 9 Results
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2005-10-05
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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