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Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib, Compared to DTPa-HBV-IPV and Hib Administered Separately

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ClinicalTrials.gov Identifier: NCT01457508
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 and safety of GlaxoSmithKline (GSK) Biologicals' (formerly SB Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared with separate administration of DTPa-HBV-IPV (Infanrix penta™) and Hib (Hiberix™) vaccine administered at 3, 5 and 11 (or 12) 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-HBV-IPV (Infanrix penta™) Biological: Hib (Hiberix™) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Study to Assess the Immunogenicity and Reactogenicity of DTPa-HBV-IPV Vaccine Mixed With Hib Vaccine to Healthy Infants at 3, 5 and 11 Months of Age, Compared to Each Vaccine Administered Separately
Study Start Date : January 1999
Actual Primary Completion Date : March 2000
Actual Study Completion Date : March 2000


Arm Intervention/treatment
Experimental: Group A
Subjects will receive one single injection of DTPa-HBV-IPV vaccine mixed with Hib vaccine.
Biological: DTPa-HBV-IPV/Hib (Infanrix hexa™)
Three doses administered intramuscularly

Active Comparator: Group B
Subjects will receive two separate injections of DTPa-HBV-IPV and Hib vaccine.
Biological: DTPa-HBV-IPV (Infanrix penta™)
Three doses administered intramuscularly

Biological: Hib (Hiberix™)
Three doses administered intramuscularly




Primary Outcome Measures :
  1. Immunogenicity with respect to the components of the study vaccine in terms of number of subjects with antibody titres greater than or equal to 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 the components of the study vaccines in terms of number of seroprotected subjects [ Time Frame: One month after the 2nd dose ( Month 3), before and one month after the 3rd dose of the primary vaccination course ( Month 8 and 9) ]
  2. Immunogenicity with respect to the 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 ( Month 8 and 9) ]
  3. Immunogenicity with respect to the components of the study vaccines in terms of antibody titres [ Time Frame: One month after the 2nd dose ( Month 3), before and one month after the 3rd dose of the primary vaccination course ( Month 8 and 9) ]
  4. Immunogenicity with respect to the components of the study vaccines in terms of vaccine response [ Time Frame: One month after the 3rd dose ( Month 9), and one month after the 2nd dose of the primary vaccination course ( Month3) ]
  5. Occurrence of solicited local symptoms [ Time Frame: Within 4 days after each vaccination and overall ]
  6. Occurrence of solicited general symptoms [ Time Frame: Within 4 days after each vaccination and overall ]
  7. Occurrence of unsolicited symptoms [ Time Frame: Within 30 days after each vaccination and overall ]
  8. Occurrence of serious adverse events [ Time Frame: Throughout the entire study up to and including 30 days post-vaccination ( Month 0 to Month 9) ]


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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 3 months 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:

The following criteria should be checked at the time of study entry. If any apply at the time of study entry, the subject must not be included in the study:

  • Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Administration of chronic immunosuppressants or other immune-modifying drugs within three months before vaccination.
  • Administration of a vaccine not foreseen by the study within 30 days before each dose of the study vaccines and ending 30 days after.
  • Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib disease.
  • History of /or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib disease or infection.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
  • History of allergic disease or reactions 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.
  • History of seizures or of any neurological disease at study entry.
  • Administration of immunoglobulins and/or any blood products since birth, or planned administration during the study period.
  • Acute disease at time of enrolment

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): NCT01457508


Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01457508    
Other Study ID Numbers: 217744/054
First Posted: October 24, 2011    Key Record Dates
Last Update Posted: June 16, 2017
Last Verified: June 2017
Keywords provided by GlaxoSmithKline:
combination vaccine
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
Pentetic Acid
Antidotes
Protective Agents
Physiological Effects of Drugs
Chelating Agents
Sequestering Agents