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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00627458
First received: February 20, 2008
Last updated: February 21, 2017
Last verified: February 2017
  Purpose
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).

Condition Intervention Phase
Acellular Pertussis
Diphtheria
Poliomyelitis
Haemophilus Influenzae Type b
Tetanus
Hepatitis B
Biological: Infanrix Hexa
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Prevention
Official Title: Immunogenicity and Reactogenicity of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine When Given as a Booster Dose

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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).

  • 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 international units per milliliter (IU/mL).

  • 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) and ≥ 100 mIU/mL.

  • 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 and ≥ 100 mIU/mL.

  • 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.

  • 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.

  • 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).

  • 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.

  • 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 ≥ 0.15 µg/mL and ≥ 1.0 µg/mL.

  • 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 and ≥ 1.0 µg/mL.

  • 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 [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 [i.e. with concentrations greater than (>) the cut-off value).

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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).

  • 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).

  • 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).

  • 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 Outcome Measures:
  • 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 .

  • 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 and ≥ 100 mIU/mL

  • 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.

  • 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 .

  • 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 and ≥ 1.0 μg/mL.

  • 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.

  • 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.

  • 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.

  • 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).

  • 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.

  • 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 (i.e. with concentrations < cut-off value) or at least doubling of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e. with concentrations > cut-off value).

  • 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.

  • 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.

  • 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.

  • 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.

  • Number of subjects reporting concomitant medications [ Time Frame: During the 4-day (Days 0-3) follow-up period after the booster vaccination ]

Enrollment: 403
Study Start Date: February 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: INFANRIX HEXA PF GROUP
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
Biological: Infanrix Hexa
Vaccine administered as a booster dose at 16-20 months of age
Other Name: GSK Biological's combined DTPa-HBV-IPV/Hib vaccine
Experimental: INFANRIX HEXA PC GROUP
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
Biological: Infanrix Hexa
Vaccine administered as a booster dose at 16-20 months of age
Other Name: GSK Biological's combined DTPa-HBV-IPV/Hib vaccine
Active Comparator: CONTROL GROUP
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
Biological: Infanrix Hexa
Vaccine administered as a booster dose at 16-20 months of age
Other Name: GSK Biological's combined DTPa-HBV-IPV/Hib vaccine

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

Ages Eligible for Study:   16 Months to 20 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  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: NCT00627458

Locations
Finland
GSK Investigational Site
Jarvenpaa, Finland, 04400
GSK Investigational Site
Oulu, Finland, 90220
GSK Investigational Site
Pori, Finland, 28100
GSK Investigational Site
Tampere, Finland, 33100
GSK Investigational Site
Turku, Finland, 20520
GSK Investigational Site
Vantaa, Finland, 01300
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 111344
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: 111344
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 111344
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: 111344
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: 111344
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 111344
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 111344
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00627458     History of Changes
Other Study ID Numbers: 111344
Study First Received: February 20, 2008
Last Updated: February 21, 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.

Keywords provided by GlaxoSmithKline:
Hexavalent vaccine
Booster

Additional relevant MeSH terms:
Hepatitis B
Diphtheria
Poliomyelitis
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
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Myelitis
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 26, 2017