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Completed

NCT Number: NCT00627458

Immunogenicity and Reactogenicity of a Booster Dose of GSK Bio's DTPa-HBV-IPV/Hib Vaccine

The purpose of this booster study is to evaluate, in subjects primed in the primary study 106786, the persistence, at the time of the booster vaccination, of antibodies elicited by the different formulation of DTPa-HBV-IPV/ Hib vaccine (Infanrix Hexa TM). The study will also evaluate the immune response of these subjects to a DTPa-HBV-IPV/Hib booster. This protocol posting deals with the objectives and outcome measures of the booster phase. The objectives and outcomes measures of the primary phase are presented in a separate protocol posting (NCT = 00376779).

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Key information

Conditions

Acellular Pertussis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Blood-Borne 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 Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Viral, Human Infections Liver Diseases Myelitis Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Pasteurellaceae Infections Picornaviridae Infections Poliomyelitis RNA Virus Infections Spinal Cord Diseases Tetanus Virus Diseases

Age range

16 month–20 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, Jarvenpaa, Finland

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About this study

This protocol posting has been updated in order to comply with the FDA AA, Sep 2007.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol
  • Subjects must have completed the full three-dose primary vaccination course with one of the formulations of the DTPa-HBV-IPV/Hib vaccine in primary study 106786.
  • A male or female between, and including, 16 and 20 months of age at the time of booster vaccination.
  • Written informed consent obtained from the parent or guardian of the subject
  • Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion criteria

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose.
  • Participation in another clinical study, between the primary study 106786 and the present booster study, or at any time during the study, in which the subject has been or will be exposed to an investigational or a non-investigational product.
  • Planned administration or administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the booster dose and ending 30 days after the booster dose.
  • Evidence of previous diphtheria, tetanus, pertussis, polio, hepatitis B and/or Hib booster vaccination or disease since the conclusion visit of study 106786.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on physical examination.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
  • Acute disease at the time of enrolment.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.

Treatment and study plan

Infanrix hexa

Biological

Vaccine administered as a booster dose at 16-20 months of age

Other names: GSK Biological's combined DTPa-HBV-IPV/Hib vaccine

Primary outcomes

  1. Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids

    Time frame: Before the booster administration (At Month 0)

    A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).

  2. Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids

    Time frame: One month after the booster vaccination (At Month 1)

    A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 IU/mL.

  3. Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)

    Time frame: Before the booster vaccination (At Month 0)

    A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 milli international units per milliliter (mIU/mL). Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL.

  4. Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)

    Time frame: One month after the booster vaccination (At Month 1)

    A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL.

  5. Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3

    Time frame: Before the booster vaccination (At Month 0)

    A seroprotected subject was defined as a subject with anti-Polio 1, 2 and 3 antibody titers ≥ the value of 8.

  6. Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3

    Time frame: One month after the booster vaccination (At Month 1)

    A seroprotected subject was defined as a subject with anti-Polio 1, 2 and 3 antibody titers ≥ the value of 8.

  7. Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)

    Time frame: Before the booster vaccination (At Month 0)

    A seroprotected subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

  8. Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)

    Time frame: One month after the booster vaccination (At Month 1)

    A seroprotected subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.

  9. Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)

    Time frame: Before the booster vaccination (At Month 0)

    A seroprotected subject was defined as a subject with anti-PRP antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL). Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL.

  10. Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)

    Time frame: One month after the booster vaccination (At Month 1)

    A seroprotected subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 µg/mL. Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL.

  11. Number of Subjects With a Vaccine Response to PT, FHA and PR

    Time frame: One month after the booster vaccination (At Month 1)

    Vaccine response was defined as the appearance of antibodies in subjects who were initially seronegative (S-) [i.e. with concentrations lower than (<) the cut-off value] or at least doubling of pre-vaccination antibody concentrations in subjects who were initially seropositive (S+) [i.e. with concentrations greater than (>) the cut-off value).

  12. Anti-D and Anti-T Antibody Concentrations

    Time frame: Before the booster vaccination (At Month 0)

    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.

  13. Anti-D and Anti-T Antibody Concentrations

    Time frame: One month after the booster vaccination (At Month 1)

    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.

  14. Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations

    Time frame: Before the booster vaccination (At Month 0)

    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.

  15. Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations

    Time frame: One month after the booster vaccination (At Month 1)

    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.

  16. Anti-HBs Antibody Concentrations

    Time frame: Before the booster vaccination (At Month 0)

    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.

  17. Anti-HBs Antibody Concentrations

    Time frame: One month after the booster vaccination (At Month 1)

    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.

  18. Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers

    Time frame: Before the booster vaccination (At Month 0)

    Antibody titers were presented as geometric mean titers (GMTs).

  19. Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers

    Time frame: One month after the booster vaccination (At Month 1)

    Antibody titers were presented as geometric mean titers (GMTs).

  20. Anti-PRP Antibody Concentrations

    Time frame: Before the booster vaccination (At Month 0)

    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL).

  21. Anti-PRP Antibody Concentrations

    Time frame: One month after the booster vaccination (At Month 1)

    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL.

Secondary outcomes

  1. Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids

    Time frame: Before (Month 0) and one month after (Month 1) the booster vaccination

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

  2. Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)

    Time frame: Before (Month 0) and one month after (Month 1) the booster vaccination

    A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL.

  3. Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3

    Time frame: Before (Month 0) and one month after (Month 1) the booster vaccination

    A seroprotected subject was defined as a subject with anti-polio 1, 2 and 3 antibody titers ≥ the value of 8.

  4. Number of Seroprotected Subjects Against PT, FHA and PRN

    Time frame: Before (Month 0) and one month after (Month 1) the booster vaccination

    A seroprotected subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL .

  5. Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)

    Time frame: Before (Month 0) and one month after (Month 1) the booster vaccination

    A seroprotected subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 μg/mL. Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL.

  6. Anti-D and Anti-T Antibody Concentrations

    Time frame: Before (Month 0) and one month after (Month 1) the booster vaccination

    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.

  7. Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations

    Time frame: Before (Month 0) and one month after (Month 1) the booster vaccination

    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.

  8. Anti-HBs Antibody Concentrations

    Time frame: Before (Month 0) and one month after (Month 1) the booster vaccination

    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.

  9. Anti-poliovirus Type 1, 2 and 3 Antibody Titers

    Time frame: Before (Month 0) and one month after (Month 1) the booster vaccination

    Antibody titers were presented as geometric mean titers (GMTs).

  10. Anti-PRP Antibody Concentrations

    Time frame: Before (Month 0) and one month after (Month 1) the booster vaccination

    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL.

  11. Number of Subjects With a Vaccine Response to PT, FHA and PR

    Time frame: One month after the booster dose (At Month 1)

    Vaccine response was defined as the appearance of antibodies in subjects who were initially seronegative (S-) (i.e. with concentrations < cut-off value) or at least doubling of pre-vaccination antibody concentrations in subjects who were initially seropositive (S+) (i.e. with concentrations > cut-off value).

  12. Number of Subjects With Any Solicited Local Symptoms

    Time frame: During the 4-day (Days 0-3) follow-up period after the booster vaccination

    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.

  13. Number of Subjects With Any Solicited General Symptoms

    Time frame: During the 4-day (Days 0-3) follow-up period after the booster vaccination

    Assessed solicited general symptoms were drowsiness, fever [defined as rectal temperature equal to or above (≥) 38.0 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade.

  14. Number of Subjects With Unsolicited Adverse Events (AEs)

    Time frame: During the 31-day (Day 0-30) follow-up period after the booster vaccination

    An unsolicited AE covers 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 and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

  15. Number of Subjects With Serious Adverse Events (SAEs)

    Time frame: From Month 0 to Month 1, during the entire study period

    Assessed SAEs include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

  16. Number of Subjects Reporting Concomitant Medications

    Time frame: During the 4-day (Days 0-3) follow-up period after the booster vaccination

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Immunogenicity and Reactogenicity of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine When Given as a Booster Dose

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Mar 3, 2008
Registry last updated
Jun 6, 2018

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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