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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00289796
Recruitment Status : Completed
First Posted : February 10, 2006
Last Update Posted : February 8, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE February 9, 2006
First Posted Date  ICMJE February 10, 2006
Last Update Posted Date February 8, 2017
Study Start Date  ICMJE July 2004
Actual Primary Completion Date April 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2017)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief Summary This study will assess immunogenicity, safety and reactogenicity of primary and booster vaccination.
Detailed Description

"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".
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Hepatitis B
Intervention  ICMJE Biological: DTPa-HBV-IPV/Hib
GSK Biologicals' combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and Haemophilus influenzae type b conjugate vaccine
Study Arms  ICMJE Active Comparator: Infanrix hexa Group
Subjects received a dose of hepatitis B vaccine at birth followed by immunization with 3 doses of Infanrix hexa™ (2, 4 and 6 months of age) and one booster dose of Infanrix hexa™ between 12 and 23 months of age. All vaccines were administered by deep intramuscular injection into the left anterolateral thigh.
Intervention: Biological: DTPa-HBV-IPV/Hib
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 9, 2014)
121
Original Enrollment  ICMJE
 (submitted: February 9, 2006)
120
Actual Study Completion Date  ICMJE December 2006
Actual Primary Completion Date April 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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."
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 5 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00289796
Other Study ID Numbers  ICMJE 210602-002
105752 ( Other Identifier: GSK )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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.
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP