Immunogenicity and Reactogenicity of a Booster Dose of GSK Bio's DTPa-HBV-IPV/Hib Vaccine
- Conditions
- Acellular PertussisHaemophilus Influenzae Type bHepatitis BPoliomyelitisDiphtheriaTetanus
- Interventions
- Biological: Infanrix Hexa
- Registration Number
- NCT00627458
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
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).
- Detailed Description
This protocol posting has been updated in order to comply with the FDA AA, Sep 2007.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 403
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description INFANRIX HEXA PC GROUP Infanrix Hexa 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. CONTROL GROUP Infanrix Hexa 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. INFANRIX HEXA PF GROUP Infanrix Hexa 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.
- Primary Outcome Measures
Name Time Method Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids 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 IU/mL.
Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs) 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. Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL.
Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3 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) 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) 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. Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL.
Number of Subjects With a Vaccine Response to PT, FHA and PR One month after the booster vaccination (At Month 1) Vaccine response was defined as the appearance of antibodies in subjects who were initially seronegative (S-) \[i.e. with concentrations lower than (\<) the cut-off value\] or at least doubling of pre-vaccination antibody concentrations in subjects who were initially seropositive (S+) \[i.e. with concentrations greater than (\>) the cut-off value).
Anti-D and Anti-T Antibody Concentrations 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 One month after the booster vaccination (At Month 1) Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.
Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers One month after the booster vaccination (At Month 1) Antibody titers were presented as geometric mean titers (GMTs).
Anti-PRP Antibody Concentrations One month after the booster vaccination (At Month 1) Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL.
Anti-HBs Antibody Concentrations One month after the booster vaccination (At Month 1) Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.
- Secondary Outcome Measures
Name Time Method Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids 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) 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. Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL.
Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3 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 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 .
Anti-HBs Antibody Concentrations 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 Before (Month 0) and one month after (Month 1) the booster vaccination Antibody titers were presented as geometric mean titers (GMTs).
Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) 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. Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL.
Anti-D and Anti-T Antibody Concentrations 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 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.
Number of Subjects With Any Solicited General Symptoms 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.
Anti-PRP Antibody Concentrations 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 One month after the booster dose (At Month 1) Vaccine response was defined as the appearance of antibodies in subjects who were initially seronegative (S-) (i.e. with concentrations \< cut-off value) or at least doubling of pre-vaccination antibody concentrations in subjects who were initially seropositive (S+) (i.e. with concentrations \> cut-off value).
Number of Subjects With Any Solicited Local Symptoms 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 Unsolicited Adverse Events (AEs) 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) 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 During the 4-day (Days 0-3) follow-up period after the booster vaccination
Trial Locations
- Locations (1)
GSK Investigational Site
🇫🇮Vantaa, Finland