Clinical trial NCT00627458: Immunogenicity and Reactogenicity of a Booster Dose of GSK Bio's DTPa-HBV-IPV/Hib Vaccine
Official title: Immunogenicity and Reactogenicity of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine When Given as a Booster Dose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acellular Pertussis
Diphtheria
Poliomyelitis
Haemophilus Influenzae Type b
Tetanus
Hepatitis B
Keywords: Hexavalent vaccine
Booster
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-03-03
Enrollment: 403
Sex: ALL
Minimum age (years): 16
Maximum age (years): 20
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids
timeFrame: Before the booster administration (At Month 0)
measure: Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids
timeFrame: One month after the booster vaccination (At Month 1)
measure: Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)
timeFrame: Before the booster vaccination (At Month 0)
measure: Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)
timeFrame: One month after the booster vaccination (At Month 1)
measure: Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3
timeFrame: Before the booster vaccination (At Month 0)
measure: Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3
timeFrame: One month after the booster vaccination (At Month 1)
measure: Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)
timeFrame: Before the booster vaccination (At Month 0)
measure: Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)
timeFrame: One month after the booster vaccination (At Month 1)
measure: Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)
timeFrame: Before the booster vaccination (At Month 0)
measure: Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)
timeFrame: One month after the booster vaccination (At Month 1)
measure: Number of Subjects With a Vaccine Response to PT, FHA and PR
timeFrame: One month after the booster vaccination (At Month 1)
measure: Anti-D and Anti-T Antibody Concentrations
timeFrame: Before the booster vaccination (At Month 0)
measure: Anti-D and Anti-T Antibody Concentrations
timeFrame: One month after the booster vaccination (At Month 1)
measure: Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
timeFrame: Before the booster vaccination (At Month 0)
measure: Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
timeFrame: One month after the booster vaccination (At Month 1)
measure: Anti-HBs Antibody Concentrations
timeFrame: Before the booster vaccination (At Month 0)
measure: Anti-HBs Antibody Concentrations
timeFrame: One month after the booster vaccination (At Month 1)
measure: Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers
timeFrame: Before the booster vaccination (At Month 0)
measure: Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers
timeFrame: One month after the booster vaccination (At Month 1)
measure: Anti-PRP Antibody Concentrations
timeFrame: Before the booster vaccination (At Month 0)
measure: Anti-PRP Antibody Concentrations
timeFrame: One month after the booster vaccination (At Month 1)
Secondary outcomes:
measure: Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids
timeFrame: Before (Month 0) and one month after (Month 1) the booster vaccination
measure: Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)
timeFrame: Before (Month 0) and one month after (Month 1) the booster vaccination
measure: Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3
timeFrame: Before (Month 0) and one month after (Month 1) the booster vaccination
measure: Number of Seroprotected Subjects Against PT, FHA and PRN
timeFrame: Before (Month 0) and one month after (Month 1) the booster vaccination
measure: Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)
timeFrame: Before (Month 0) and one month after (Month 1) the booster vaccination
measure: Anti-D and Anti-T Antibody Concentrations
timeFrame: Before (Month 0) and one month after (Month 1) the booster vaccination
measure: Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations
timeFrame: Before (Month 0) and one month after (Month 1) the booster vaccination
measure: Anti-HBs Antibody Concentrations
timeFrame: Before (Month 0) and one month after (Month 1) the booster vaccination
measure: Anti-poliovirus Type 1, 2 and 3 Antibody Titers
timeFrame: Before (Month 0) and one month after (Month 1) the booster vaccination
measure: Anti-PRP Antibody Concentrations
timeFrame: Before (Month 0) and one month after (Month 1) the booster vaccination
measure: Number of Subjects With a Vaccine Response to PT, FHA and PR
timeFrame: One month after the booster dose (At Month 1)
measure: Number of Subjects With Any Solicited Local Symptoms
timeFrame: During the 4-day (Days 0-3) follow-up period after the booster vaccination
measure: Number of Subjects With Any Solicited General Symptoms
timeFrame: During the 4-day (Days 0-3) follow-up period after the booster vaccination
measure: Number of Subjects With Unsolicited Adverse Events (AEs)
timeFrame: During the 31-day (Day 0-30) follow-up period after the booster vaccination
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: From Month 0 to Month 1, during the entire study period
measure: Number of Subjects Reporting Concomitant Medications
timeFrame: During the 4-day (Days 0-3) follow-up period after the booster vaccination
Other outcomes:
Locations:
city: Jarvenpaa
country: Finland
facility: GSK Investigational Site
city: Oulu
country: Finland
facility: GSK Investigational Site
city: Pori
country: Finland
facility: GSK Investigational Site
city: Tampere
country: Finland
facility: GSK Investigational Site
city: Turku
country: Finland
facility: GSK Investigational Site
city: Vantaa
country: Finland
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: