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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00289796
First received: February 9, 2006
Last updated: February 6, 2017
Last verified: February 2017
  Purpose
This study will assess immunogenicity, safety and reactogenicity of primary and booster vaccination.

Condition Intervention Phase
Hepatitis B
Biological: DTPa-HBV-IPV/Hib
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Prevention
Official 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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.


Enrollment: 121
Study Start Date: July 2004
Study Completion Date: December 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Biological: DTPa-HBV-IPV/Hib
GSK Biologicals' combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and Haemophilus influenzae type b conjugate vaccine

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".
  Eligibility

Ages Eligible for Study:   up to 5 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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."
  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: NCT00289796

Locations
Germany
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 210602-002
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: 210602-002
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: 210602-002
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 210602-002
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: 210602-002
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: 210602-002
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00289796     History of Changes
Other Study ID Numbers: 210602-002  105752 
Study First Received: February 9, 2006
Last Updated: February 6, 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
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 20, 2017