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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00169442
First received: September 12, 2005
Last updated: May 8, 2017
Last verified: May 2017
  Purpose
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.

Condition Intervention Phase
Whole Cell Pertussis Diphtheria Hepatitis B Tetanus Haemophilus Influenzae Type b Biological: Tritanrix™-HepB/Hiberix™ Kft. Biological: Tritanrix™-HepB/Hiberix™ Biological: Hiberix™ Biological: Polyribosil-Ribitol-Phosphate (PRP) vaccine Biological: Tritanrix™-HepB Kft Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Prevention
Official 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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.

  • 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.

  • 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).

  • 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.

  • 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).

  • 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).

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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 Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.


Enrollment: 745
Actual Study Start Date: February 10, 2005
Study Completion Date: March 10, 2006
Primary Completion Date: March 1, 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tritanrix-HepB/Hiberix Kft. Mix Group
Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
Biological: Tritanrix™-HepB/Hiberix™ Kft.
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 Name: DTPw-HBV/Hib Kft
Experimental: Tritanrix-HepB/Hiberix Kft. Ref Group
Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
Biological: Tritanrix™-HepB/Hiberix™ Kft.
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 Name: DTPw-HBV/Hib Kft
Biological: Tritanrix™-HepB/Hiberix™
GSK Biologicals' combined diphtheria, tetanus, whole cell Bordetella pertussis, hepatitis B and Haemophilus Influenzae type b vaccine
Other Name: DTPw-HBV/Hib
Experimental: HB Tritanrix-HepB/Hiberix Kft. Mix Group
Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
Biological: Tritanrix™-HepB/Hiberix™ Kft.
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 Name: DTPw-HBV/Hib Kft
Experimental: Tritanrix-HepB Kft.+Hiberix Group
Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
Biological: Hiberix™
GSK Biologicals' Haemophilus influenzae type b vaccine
Biological: Tritanrix™-HepB Kft
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 Name: DTPw-HBV Kft
Experimental: PRP Tritanrix-HepB Kft. Mix Group
Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received plain Polyribosil-Ribitol-Phosphate (PRP) polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
Biological: Tritanrix™-HepB/Hiberix™ Kft.
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 Name: DTPw-HBV/Hib Kft
Biological: Polyribosil-Ribitol-Phosphate (PRP) vaccine
plain PRP polysaccharide vaccine
Biological: Tritanrix™-HepB Kft
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 Name: DTPw-HBV Kft
Experimental: PRP Tritanrix-HepB Kft. Ref Group
Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received plain Polyribosil-Ribitol-Phosphate (PRP) polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
Biological: Tritanrix™-HepB/Hiberix™
GSK Biologicals' combined diphtheria, tetanus, whole cell Bordetella pertussis, hepatitis B and Haemophilus Influenzae type b vaccine
Other Name: DTPw-HBV/Hib
Biological: Polyribosil-Ribitol-Phosphate (PRP) vaccine
plain PRP polysaccharide vaccine
Biological: Tritanrix™-HepB Kft
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 Name: DTPw-HBV Kft

Detailed Description:
  • 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.
  Eligibility

Ages Eligible for Study:   10 Months to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00169442

Locations
Philippines
GSK Investigational Site
Muntinlupa, Philippines, 1781
GSK Investigational Site
Pasay City, Philippines
GSK Investigational Site
Quezon CIty, Philippines, 1109
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications:
Gatchalian et al. A new DTPw-HBV/Hib vaccine: Immunogenic and safe for primary vaccination and booster dosing in the second year of life - 5th World Congress WSPID, Bangkok, Thailand, 15-18 Nov 2007

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 104065
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 104065
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 104065
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 104065
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 104065
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 104065
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00169442     History of Changes
Other Study ID Numbers: 104065
Study First Received: September 12, 2005
Results First Received: January 10, 2017
Last Updated: May 8, 2017
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Additional relevant MeSH terms:
Hepatitis B
Diphtheria
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatitis
Liver Diseases
Digestive System Diseases
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 23, 2017