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Completed

NCT Number: NCT00169442

Immune Memory of DTPw-HBV/Hib Vaccine Following Primary Vaccination, Immuno & Reacto of a Booster Dose Given in Infants

To assess the immune memory following primary vaccination of DTPw-HBV/Hib vaccine and to assess immunogenicity and reactogenicity of a booster dose given at 15 - 18 months of age.

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Key information

Conditions

Whole Cell Pertussis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Clostridium Infections Communicable Diseases Corynebacterium Infections DNA Virus Infections Digestive System Diseases Diphtheria 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 Pasteurellaceae Infections Tetanus Virus Diseases

Age range

10 month–18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, City of Muntinlupa, Philippines

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About this study

  • Subjects who received DTPw-HBV/Hib in the primary vaccination without HBV at birth will be randomised (1:3 ratio) to receive either: Plain PRP at 10 months of age followed by DTPw-HBV at 15-18 months of age or DTPw-HBV/Hib at 15-18 months of age.
  • Subjects who received DTPw-HBV + Hib in the primary vaccination without HBV at birth will receive DTPw-HBV + Hib as a booster.
  • Subjects who received DTPw-HBV/Hib in the primary vaccination with HBV at birth will receive DTPw-HBV/Hib vaccine as a booster.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

For subjects receiving Plain PRP followed by DTPw-HBV:

Male or female infant, 10 to 11 months of age, who previously completed the three-dose primary vaccination course with the DTPw-HBV/Hib vaccine.

For subjects receiving DTPw-HBV/Hib or DTPw-HBV + Hib:

Male or female infant, 15-18 months of age, who previously completed the three-dose primary vaccination course with the DTPw-HBV/Hib vaccine.

For all subjects:

  • Subjects who the investigator believes that their parent/guardian can and will comply with the requirements of the protocol.
  • Free of obvious health problems as established by medical history and clinical examination

Exclusion criteria

  • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding administration of the study vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to administration of the study vaccine.
  • Planned administration/administration of a vaccine not foreseen by the study protocol starting 30 days before and ending 30 days after administration of the study vaccine with the exception of oral polio vaccine.

Treatment and study plan

Tritanrix™-HepB/Hiberix™ Kft.

Biological

GlaxoSmithKline (GSK) Biologicals Korlatolt Felelossegu Tarsasag [Kft] (Limited Company) combined diphtheria (D), tetanus (T), whole cell Bordetella pertussis (Pw), hepatitis B vaccine with new sources of D, T and Pw antigens mixed with Haemophilus influenzae type b (Hib2.5) vaccine.

Other names: DTPw-HBV/Hib Kft

Tritanrix™-HepB/Hiberix™

Biological

GSK Biologicals' combined diphtheria, tetanus, whole cell Bordetella pertussis, hepatitis B and Haemophilus Influenzae type b vaccine

Other names: DTPw-HBV/Hib

Hiberix™

Biological

GSK Biologicals' Haemophilus influenzae type b vaccine

Polyribosil-Ribitol-Phosphate (PRP) vaccine

Biological

plain PRP polysaccharide vaccine

Tritanrix™-HepB Kft

Biological

GSK Biologicals Korlatolt Felelossegu Tarsasag [Kft] (Limited Company) combined diphtheria, tetanus, whole cell Bordetella pertussis, hepatitis B vaccine with new sources of D, T and Pw antigens produced at GSK Biologicals Kft., Gödöllö, Hungary.

Other names: DTPw-HBV Kft

Primary outcomes

  1. Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL

    Time frame: At Month 1, post-PRP challenge

    The number of subjects with anti-PRP antibody concentrations equal to or above (≥) 0.15 μg/mL and ≥ 1.0 μg/mL, at one month after the PRP challenge.

  2. Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL.

    Time frame: At Month 1, post-booster vaccination

    The number of subjects with anti-PRP antibody concentrations equal to or above (≥) 0.15 μg/mL and ≥ 1.0 μg/mL, at one month post-booster vaccination.

  3. Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T)

    Time frame: At Month 1, post-booster vaccination

    A seroprotected subject was defined as a vaccinated subject, with anti-D and anti-T antibody concentrations equal to or above (≥) 0.1 International Units per milliliter (IU/mL).

  4. Seroprotection Rates for Anti-D Antibodies

    Time frame: At Month 1, post-booster vaccination

    The seroprotection rate is defined as the estimated proportion of subjects with protective antibodies as assessed by the Enzyme-Linked Immunosorbent Assay (ELISA) (antibody concentration ≥ 0.1 IU/mL), or by Vero-cell neutralisation assay (antibody concentration ≥ 0.016 IU/mL), for subjects seronegative as assessed by ELISA.

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

    Time frame: At Month 1, post-booster vaccination

    A seroprotected subject was defined as a vaccinated subject with an anti-HBs antibody concentration equal to or above (≥) 10 milli International Units per milliliter (mIU/mL).

  6. Number of Seroprotected Subjects Against Bordetella Pertussis (BPT)

    Time frame: At Month 1, post-booster vaccination

    A seroprotected subject was defined as a vaccinated subject with an anti-BPT antibody concentration equal to or above (≥) 15 ELISA units per milliliter (EL.U/mL).

  7. Number of Subjects With Booster Response to BPT Antigen

    Time frame: At Month 1, post-booster vaccination

    The booster response was defined as:

    • an anti-BPT antibody concentration equal to or above (≥) the cut-off value (15 EL.U/mL) at post-booster vaccination in subjects seronegative (anti-BPT antibody concentration < 15 EL.U/mL) prior to administration of the booster dose; or
    • at least a 2-fold increase in antibody concentration from pre- to post-vaccination time points, in subjects who were seropositive (anti-BPT antibody concentration ≥ 15 EL.U/mL) prior to the administration of the booster dose.

  8. Anti-PRP Antibody Concentrations

    Time frame: At Month 1, post-PRP challenge

    Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram per milliliter (μg/mL), as assessed by ELISA.

  9. Anti-PRP Antibody Concentrations.

    Time frame: At Month 1, post-booster vaccination

    Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram per milliliter (μg/mL), as assessed by ELISA.

  10. Anti-D and Anti-T Antibody Concentrations

    Time frame: At Month 1, post-booster vaccination

    Anti-D and anti-T antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in International Units per milliliter (IU/mL), as assessed by ELISA.

  11. Anti-HBs Antibody Concentrations

    Time frame: At Month 1, post-booster vaccination

    Anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL), as assessed by ELISA.

  12. Anti-BPT Antibody Concentrations

    Time frame: At Month 1, post-booster vaccination

    Anti-BPT antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL), as assessed by ELISA.

Secondary outcomes

  1. Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL

    Time frame: At Month 0, prior to the PRP challenge

    The number of subjects with anti-PRP antibody concentrations equal to or above (≥) 0.15 μg/mL and ≥ 1.0 μg/mL, prior to the PRP challenge.

  2. Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL.

    Time frame: At Month 0, prior to the PRP challenge

    The number of subjects with anti-PRP antibody concentrations equal to or above (≥) 0.15 μg/mL and ≥ 1.0 μg/mL, prior to the booster vaccination.

  3. Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ the Cut-off Value

    Time frame: At Month 0, prior to the PRP challenge

    The number of subjects with anti-D antibody concentrations equal to or above (≥) the cut-off value of 0.1 IU/mL as assessed by ELISA, (or ≥ 0.016 IU/mL as assessed by the neutralisation assay on Vero cells in subjects seronegative by ELISA testing) and, the number of subjects with anti-T antibody concentrations ≥ the cut-off value of 0.1 IU/mL as assessed by ELISA.

  4. Seroprotection Rates for Anti-D Antibodies

    Time frame: At Month 0, prior to the PRP challenge

    The seroprotection rate is defined as the estimated proportion of subjects with protective antibodies as assessed by ELISA (antibody concentration ≥ 0.1 IU/mL), or by Vero-cell neutralisation assay (antibody concentration ≥ 0.016 IU/mL), for subjects seronegative as assessed by ELISA.

  5. Number of Subjects With Anti-HBs Antibody Concentrations ≥ the Cut-off Value

    Time frame: At Month 0, prior to the PRP challenge

    The number of subjects with anti-HBs antibody concentrations equal to or above (≥) the cut-off value of 10 mIU/mL, prior to the booster vaccination.

  6. Number of Subjects With Anti-BPT Antibody Concentrations ≥ the Cut-off Value

    Time frame: At Month 0, prior to the PRP challenge

    The number of subjects with anti-BPT antibody concentrations equal to or above (≥) the cut-off value of 15 EL.U/mL, prior to the booster vaccination.

  7. Anti- PRP Antibody Concentrations

    Time frame: At Month 0, prior to the PRP challenge

    Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram per milliliter (μg/mL), as assessed by ELISA.

  8. Anti- PRP Antibody Concentrations.

    Time frame: At Month 0, prior to the PRP challenge

    Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram per milliliter (μg/mL), as assessed by ELISA.

  9. Anti-D and Anti-T Antibody Concentrations.

    Time frame: At Month 0, prior to the PRP challenge

    Anti-D and anti-T antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in International Units per milliliter (IU/mL), as assessed by ELISA.

  10. Anti-HBs Antibody Concentrations.

    Time frame: At Month 0, prior to the PRP challenge

    Anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL), as assessed by ELISA.

  11. Anti-BPT Antibody Concentrations.

    Time frame: At Month 0, prior to the PRP challenge

    Anti-BPT antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL), as assessed by ELISA.

  12. Number of Subjects With Any and Grade 3 Solicited Local Symptoms

    Time frame: During the 4-Day (Days 0-3) post-PRP challenge

    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.

  13. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

    Time frame: During the 4-Day (Days 0-3) post-PRP challenge

    Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Grade 3 irritability = crying that could not be comforted and prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = symptom assessed by the investigator as related to the vaccination.

  14. Number of Subjects With Any and Grade 3 Solicited Local Symptoms.

    Time frame: During the 4-Day (Days 0-3) post-booster vaccination period

    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.

  15. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.

    Time frame: During the 4-Day (Days 0-3) post-booster vaccination period

    Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Grade 3 irritability = crying that could not be comforted and prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = symptom assessed by the investigator as related to the vaccination.

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

    Time frame: During the 31-Day (Day 0-30) follow-up period

    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.

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

    Time frame: During the entire study period (from Month 0 to Month 9.5)

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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Immune Memory of GSK's DTPw-HBV/Hib Vaccine by Giving Plain PRP Polysaccharide at 10 Mths. Immuno & Reacto of a Booster Dose of DTPw-HBV/Hib or DTPw-HBV or DTPw-HBV+Hib at 15-18 Mths in Infants Previously Primed With DTPw-HBV/Hib

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Sep 15, 2005
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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