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Completed

NCT Number: NCT01457508

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

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.

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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 3

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

DTPa-HBV-IPV/Hib (Infanrix hexa™)

Biological

Three doses administered intramuscularly

DTPa-HBV-IPV (Infanrix penta™)

Biological

Three doses administered intramuscularly

Hib (Hiberix™)

Biological

Three doses administered intramuscularly

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
1999
Primary completion
2000
Study completion
2000
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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