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OpenTrials
Completed

NCT Number: NCT00289796

Assess Feasibility of an Acellular Pertussis Vaccine (Pa) Given Soon After Birth, Followed by 3-dose Primary Vaccination With the DTPa-HBV-IPV/Hib Vaccine

This study will assess immunogenicity, safety and reactogenicity of primary and booster vaccination.

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Key information

Conditions

Hepatitis B Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Age range

2 day–5 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site

Mainz, Rhineland-Palatinate, 55131, Germany

About this study

"There will be two groups in this study:

  • one group will receive a birth dose of Pa vaccine and 3 doses of DTPa-HBV-IPV/Hib vaccine as primary vaccination and a dose of DTPa-HBV-IPV/Hib vaccine as booster vaccination
  • the control group will receive a birth dose of hepatitis B vaccine and 3 doses of DTPa-HBV-IPV/Hib vaccine as primary vaccination and a dose of DTPa-HBV-IPV/Hib vaccine as booster vaccination".

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

For the primary vaccination phase

  • Healthy newborn male or female infant 2 to 5 days old at the time of the first vaccination & written informed consent taken from the parents/guardians of the subject
  • Born at term (gestational age 37-42 weeks) after an uncomplicated pregnancy
  • Birth weight >= 2.5 kg and 5 minute Apgar >= 7
  • Mother seronegative for Hepatitis B surface antigen (HBsAg) For the booster vaccination phase
  • A healthy male or female between, and including, 12 and 23 months of age at the time of booster vaccination who has completed the primary vaccination course in the primary vaccination phase with written informed consent obtained from the parent or guardian of the subject

Exclusion criteria

For the primary vaccination phase

  • Mother known or suspected to be seropositive for HIV (testing not required for inclusion)
  • Planned use of any investigational or non-registered product (drug or vaccine) other than the study vaccines during the study
  • Planned administration of immuno-suppressants or other immune-modifying drugs, administration of immunoglobulins and/or any blood products since birth or planned administration during the study.
  • Administration of immunoglobulins and/or any blood products to the mother during pregnancy
  • Neonatal jaundice requiring parenteral treatment (light therapy for physiological jaundice is allowed)
  • At risk of pneumococcal disease or planning to receive Prevenar™ during the study period
  • Administration or planned administration of BCG vaccination during the study period
  • Acute disease at the time of vaccination. For the booster vaccination phase
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the booster dose, or planned use during the booster phase.
  • Evidence of previous diphtheria, tetanus, pertussis, polio, hepatitis B and/or Hib booster vaccination since the study conclusion visit of the primary vaccination phase.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
  • Administration/ planned administration of a vaccine not foreseen by the study protocol, administration/ planned administration of immunoglobulins and/or any blood products during the period starting 30 days before the administration of the booster dose and ending 30 days after the booster dose.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose."

Treatment and study plan

DTPa-HBV-IPV/Hib

Biological

GSK Biologicals' combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and Haemophilus influenzae type b conjugate vaccine

Primary outcomes

  1. Number of seropositive subjects for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies

    Time frame: At Month 0

    A seropositive subject was defined a subject with antibody concentrations ≥ 5 EL.U/mL.

  2. Number of seropositive subjects for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies

    Time frame: At Month 3

    A seropositive subject was defined a subject with antibody concentrations ≥ 5 EL.U/mL.

  3. Number of seropositive subjects for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies

    Time frame: At Month 5

    A seropositive subject was defined a subject with antibody concentrations ≥ 5 EL.U/mL.

  4. Number of seropositive subjects for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies

    Time frame: At Month 7

    A seropositive subject was defined a subject with antibody concentrations ≥ 5 EL.U/mL.

  5. Antibody concentrations for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies

    Time frame: At Month 0

    Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.

  6. Antibody concentrations for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies

    Time frame: At Month 3

    Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.

  7. Antibody concentrations for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies

    Time frame: At Month 5

    Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.

  8. Antibody concentrations for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies

    Time frame: At Month 7

    Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.

  9. Number of seropositive subjects for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies

    Time frame: At Month 1 Post-Booster

    A seropositive subject was defined a subject with antibody concentrations ≥ 5 EL.U/mL.

  10. Antibody concentrations for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies

    Time frame: At Month 1 Post-Booster

    Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.

  11. Modified vaccine response for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies

    Time frame: At Month 7

    Modified vaccine response was defined as: For initially seronegative subjects, antibody concentration 5 EL.U/mL at one month after the third dose of Infanrix hexa™. For initially seropositive subjects: antibody concentration at one month post vaccination 0.25 fold the pre-vaccination antibody concentration.

  12. Modified vaccine response for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies

    Time frame: At Month 1 Post-Booster

    Modified vaccine response was defined as: For initially seronegative subjects, antibody concentration 5 EL.U/mL at one month after the third dose of Infanrix hexa™. For initially seropositive subjects: antibody concentration at one month post vaccination 0.25 fold the pre-vaccination antibody concentration.

  13. Number of seroprotected subjects for anti-Hepatitis B surface antigen (anti-HBs) antibodies

    Time frame: At Month 7

    A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.

  14. Number of seroprotected subjects for anti-Hepatitis B surface antigen (anti-HBs) antibodies

    Time frame: At pre-booster vaccination (Month 0 BST)

    A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.

  15. Number of seroprotected subjects for anti-Hepatitis B surface antigen (anti-HBs) antibodies

    Time frame: At Month 1 post-booster vaccination

    A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.

  16. Antibody concentrations for anti-Hepatitis B surface antigen (anti-HBs) antibodies

    Time frame: At Month 7

    Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 10 mIU/mL.

  17. Antibody concentrations for anti-Hepatitis B surface antigen (anti-HBs) antibodies

    Time frame: At pre-booster vaccination (Month 0 BST)

    Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 10 mIU/mL.

  18. Antibody concentrations for anti-Hepatitis B surface antigen (anti-HBs) antibodies

    Time frame: At Month 1 post-booster vaccination

    Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 10 mIU/mL.

  19. Number of seroprotected subjects for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies

    Time frame: At Month 7

    A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL.

  20. Number of seroprotected subjects for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies

    Time frame: At pre-booster vaccination (Month 0 BST)

    A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL.

  21. Number of seroprotected subjects for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies

    Time frame: At Month 1 post-booster vaccination

    A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL.

  22. Antibody concentrations for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies

    Time frame: At Month 7

    Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.1 IU/mL.

  23. Antibody concentrations for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies

    Time frame: At pre-booster vaccination (Month 0 BST)

    Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.1 IU/mL.

  24. Antibody concentrations for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies

    Time frame: At Month 1 post-booster vaccination

    Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.1 IU/mL.

  25. Number of seroprotected subjects for anti-polyribosyl ribitol phosphate (anti-PRP)

    Time frame: At Month 7

    A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.15 g/mL.

  26. Number of seroprotected subjects for anti-polyribosyl ribitol phosphate (anti-PRP)

    Time frame: At pre-booster vaccination (Month 0 BST)

    A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.15 g/mL.

  27. Number of seroprotected subjects for anti-polyribosyl ribitol phosphate (anti-PRP)

    Time frame: At Month 1 post-booster vaccination

    A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.15 g/mL.

  28. Antibody concentrations for anti-polyribosyl ribitol phosphate (anti-PRP)

    Time frame: At Month 7

    Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 g/mL.

  29. Antibody concentrations for anti-polyribosyl ribitol phosphate (anti-PRP)

    Time frame: At pre-booster vaccination (Month 0 BST)

    Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 g/mL.

  30. Antibody concentrations for anti-polyribosyl ribitol phosphate (anti-PRP)

    Time frame: At Month 1 post-booster vaccination

    Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 g/mL.

  31. Number of subjects with solicited general symptoms

    Time frame: During the 8-day (Day 0-Day 7) follow-up period after the any dose and booster vaccination

    The solicited local symptoms assessed were Drowsiness, Temperature (Fever), Irritability and Loss of appetite. Temperature = Fever ≥ 38.0 °C. Grade 3 drowsiness = drowsiness that prevented normal activity; Grade 3 irritability = crying that could not be comforted/prevented normal activity; Grade 3 loss of appetite = not eating at all; Grade 3 Temperature = > 39.5 °C. Related = symptoms considered by the investigator to have a causal relationship to vaccination.

  32. Number of subjects with unsolicited adverse events (AES)

    Time frame: Occurring within Day 0-30 following primary and booster vaccination

    An AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Assess the Feasibility of an Investigational Vaccination Regimen, Compared to a 3-dose Primary Vaccination With GSK Biologicals' Infanrix Hexa™ (DTPa-HBV-IPV/Hib Vaccine) Following Hepatitis B Vaccination at Birth. Primary Vaccination is Followed in the 2nd Year of Life by a Booster Dose of Infanrix-hexa

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Feb 10, 2006
Registry last updated
Feb 8, 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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