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NCT Number: NCT01457495

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

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.

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Key information

Conditions

Hepatitis B Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Bordetella Infections Central Nervous System Diseases Central Nervous System Infections Clostridium Infections Communicable Diseases Corynebacterium Infections DNA Virus Infections Digestive System Diseases Diphtheria Enterovirus Infections Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Haemophilus Infections Haemophilus Influenzae Type b (Hib) Hepadnaviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Myelitis Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Pasteurellaceae Infections Pertussis Picornaviridae Infections Poliomyelitis RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Spinal Cord Diseases Tetanus Virus Diseases Whooping Cough

Age range

12 week–16 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DTPa-HBV-IPV/Hib (Infanrix-hexa™)

Biological

3 doses administered intramuscularly into the right thigh at study month 0, 2 and 8

DTPa-IPV/Hib (Infanrix-IPV/Hib™)

Biological

3 doses administered intramuscularly into the right thigh at study month 0, 2 and 8

HBV (Engerix™-B)

Biological

3 doses administered intramuscularly into the left thigh at study month 0, 2 and 8

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
1998
Primary completion
1999
Study completion
1999
First posted
Oct 24, 2011
Registry last updated
Jun 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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