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Immunogenicity and Safety of DTPa-HBV-IPV/Hib Compared to DTPa-IPV/Hib and HBV Administered Concomitantly

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: NCT01457495
Recruitment Status : Completed
First Posted : October 24, 2011
Last Update Posted : June 16, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
This study will assess the immunogenicity of GlaxoSmithKline (GSK) Biologicals' (formerly SmithKline Beecham Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared to the separate administration of DTPa-HBV-IPV (Infanrix™ penta) and Hib (Hiberix™) vaccines administered at 3 and 5 months of age.

Condition or disease Intervention/treatment Phase
Hepatitis B Diphtheria Haemophilus Influenzae Type b (Hib) Poliomyelitis Pertussis Tetanus Biological: DTPa-HBV-IPV/Hib (Infanrix-hexa™) Biological: DTPa-IPV/Hib (Infanrix-IPV/Hib™) Biological: HBV (Engerix™-B) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 312 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Study to Assess Immunogenicity and Reactogenicity of SB Biologicals' DTPa-HBV-IPV/Hib Vaccine Given as Three-dose Primary Vaccination Course Compared to DTPa-IPV/Hib and HBV Administered Concomitantly at Separate Sites
Study Start Date : September 1998
Actual Primary Completion Date : September 1999
Actual Study Completion Date : September 1999


Arm Intervention/treatment
Experimental: DTPa 1 Group Biological: DTPa-HBV-IPV/Hib (Infanrix-hexa™)
3 doses administered intramuscularly into the right thigh at study month 0, 2 and 8

Active Comparator: DTPa 2 Group Biological: DTPa-IPV/Hib (Infanrix-IPV/Hib™)
3 doses administered intramuscularly into the right thigh at study month 0, 2 and 8

Biological: HBV (Engerix™-B)
3 doses administered intramuscularly into the left thigh at study month 0, 2 and 8




Primary Outcome Measures :
  1. Number of subjects with antibody titers equal to or greater than cut-off value. [ Time Frame: One month after the 2nd dose of the primary vaccination course (month 3) ]

Secondary Outcome Measures :
  1. Immunogenicity with respect to components of the study vaccines in terms of number of seropositive subjects [ Time Frame: One month after the 2nd dose (Month 3), before and one month after the 3rd dose of the primary vaccination course (Months 8 and 9) ]
  2. Immunogenicity with respect to components of the study vaccines in terms of antibody titers [ Time Frame: One month after the 2nd dose (Month 3), before and one month after the 3rd dose of the primary vaccination course (Months 8 and 9) ]
  3. Immunogenicity with respect to components of the study vaccines in terms of number of subjects with a vaccine response [ Time Frame: One month after the 3rd dose of the primary vaccination course (Month 9) ]
  4. Occurrence of solicited local symptoms [ Time Frame: Within 4 days after each vaccination and overall ]
  5. Occurrence of solicited general symptoms [ Time Frame: Within 4 days after each vaccination and overall ]
  6. Occurrence of unsolicited symptoms [ Time Frame: Within 30 days after each vaccination, and overall ]
  7. Occurrence of serious AEs [ Time Frame: Throughout the entire study (approximately 9 months per subject) up to and including 30 days post-vaccination ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Weeks to 16 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • A male or female between 12 and 16 weeks of age at the time of the first vaccination.
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.
  • Written informed consent obtained from the parents or guardians of the subject after they have been advised of the risks and benefits of the study in a language which they clearly understood, and before performance of any study procedure.

Exclusion Criteria:

  • Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine.
  • Administration of chronic immunosuppressants or immune-modifying drugs during the study period.
  • Administration of a vaccine not foreseen by the study protocol during the period starting from one month before each dose and ending one month after each dose.
  • Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib diseases.
  • History of/or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib disease.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
  • History of allergic disease or reaction likely to be exacerbated by any component of the vaccine, including allergic reactions to neomycin and polymyxin B.
  • Major congenital defects or serious chronic illness.
  • Progressive neurological disorders.
  • Administration of immunoglobulins and/or any blood products since birth and during the study period.
  • Acute febrile illness at the time of planned vaccination.

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): NCT01457495


Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01457495    
Other Study ID Numbers: 217744/031
First Posted: October 24, 2011    Key Record Dates
Last Update Posted: June 16, 2017
Last Verified: June 2017
Keywords provided by GlaxoSmithKline:
Infants
combined vaccine
DTPa-HBV-IPV/Hib
DTPa-IPV/Hib
safety
Immunogenicity
HBV
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
Pentetic Acid
Antidotes
Protective Agents
Physiological Effects of Drugs
Chelating Agents
Sequestering Agents