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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01457547
Recruitment Status : Completed
First Posted : October 24, 2011
Last Update Posted : August 5, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hepatitis B Poliomyelitis Diphtheria Acellular Pertussis Tetanus Haemophilus Influenzae Type b Biological: DTPa-HBV-IPV/Hib Vaccine (INFANRIX™ HEXA) Biological: DTPa-HBV-IPV-Hib vaccine (HEXAVAC™) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 494 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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 Start Date : October 2003
Actual Primary Completion Date : May 2005
Actual Study Completion Date : May 2005


Arm Intervention/treatment
Experimental: DTPa 1 Group Biological: DTPa-HBV-IPV/Hib Vaccine (INFANRIX™ HEXA)
Three doses administered intramuscularly

Active Comparator: DTPa 2 Group Biological: DTPa-HBV-IPV-Hib vaccine (HEXAVAC™)
Three doses administered intramuscularly




Primary Outcome Measures :
  1. Immunogenicity with respect to the components of the study vaccine in terms of antibody concentrations [ Time Frame: Prior to the third primary vaccination dose ( Months 8-9) ]

Secondary Outcome Measures :
  1. Immunogenicity with respect to the components of the study vaccine in terms of antibody concentrations [ Time Frame: One month after the second and third primary vaccination dose (Month 3 and Months 9-10) ]
  2. Immunogenicity with respect to the components of the study vaccine in terms of number of seroprotected subjects defined by antibody concentration [ Time Frame: Prior to and one month after the third primary vaccination dose ( Months 8-9 and Months 9-10) ]
  3. Immunogenicity with respect to the components of the study vaccine in terms of number of seropositive subjects [ Time Frame: Prior to and one month after the third primary vaccination dose ( Months 8-9 and Months 9-10) ]
  4. Occurrence of solicited symptoms [ Time Frame: Within 4 days (Day 0 -Day 3) after each vaccine dose ]
  5. Occurrence of a grade "3" solicited symptoms [ Time Frame: Within 4 days (Day 0 -Day 3) after each vaccine dose ]
  6. Occurrence of unsolicited adverse events [ Time Frame: Within 31 days after any vaccination ]
  7. Occurrence of Serious Adverse Events [ Time Frame: Throughout the entire study up to (Month 0 to Month 9-10) and including 30 days after last vaccination (Month 9-10) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   8 Weeks to 15 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01457547


Locations
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Finland
GSK Investigational Site
Helsinki, Finland, 00300
Italy
GSK Investigational Site
Bologna, Emilia-Romagna, Italy, 40138
GSK Investigational Site
Pavia, Lombardia, Italy, 27100
GSK Investigational Site
Bari, Puglia, Italy, 70124
GSK Investigational Site
Galatina (LE), Puglia, Italy, 73013
GSK Investigational Site
Maglie (LE), Puglia, Italy, 73024
GSK Investigational Site
Sassari, Sardegna, Italy, 07100
Sweden
GSK Investigational Site
Linköping, Sweden, SE-581 85
GSK Investigational Site
Örebro, Sweden, SE-701 85
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
Additional Information:
Study Data/Documents: Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 217744/094
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 217744/094
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 217744/094
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 217744/094
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 217744/094
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 217744/094
For additional information about this study please refer to the GSK Clinical Study Register

Publications:
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01457547    
Other Study ID Numbers: 217744/094
First Posted: October 24, 2011    Key Record Dates
Last Update Posted: August 5, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Keywords provided by GlaxoSmithKline:
HEXAVACTM
InfanrixTM HEXA
DTPa-HBV-IPV-Hib
DTPa-HBV-IPV/Hib
Additional relevant MeSH terms:
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Diphtheria
Hepatitis B
Poliomyelitis
Hepatitis
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Bacterial Infections
Gram-Positive Bacterial Infections
Corynebacterium Infections
Actinomycetales Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Myelitis
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Edetic Acid
Vaccines
Pentetic Acid
Immunologic Factors
Physiological Effects of Drugs
Antidotes
Protective Agents