Clinical trial NCT00332566: Assess Immunogenicity, Reactogenicity, Safety of a Booster of GSK Biologicals DTPw-HBV/Hib Kft Compared to DTPw-HBV/Hib
Official title: Immunogenicity, Reactogenicity & Safety of a Booster Dose of GSK Biologicals' DTPw-HBV/Hib Kft Vaccine Vs GSK Biologicals' DTPw-HBV/Hib Vaccine, in Infants Who Received a 3-Dose Primary Vaccination Course With the Same Vaccines.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B
Whole Cell Pertussis
Tetanus
Haemophilus Influenzae Type b
Diphtheria
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-06-01
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This booster study will assess the immunogenicity, reactogenicity and safety of a booster dose of GSK Biologicals' DTPw-HBV/Hib Kft. vaccine versus DTPw-HBV/Hib vaccine, in healthy children, 18 to 24 months of age, who received the same vaccine for primary vaccination. Prior to the booster dose, this study will also assess the persistence of antibodies to the vaccine antigen components administered in the primary vaccination course. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Eligibility criteria: Inclusion Criteria:

* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
* A male or female toddler, 18 to 24 months of age at the time of booster vaccination, who completed the three-dose primary vaccination course in the 101223 study.
* 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 vaccines within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose.
* Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before and ending 30 days after administration of the booster vaccine dose, with the exception of oral polio vaccine (OPV).
* Previous booster vaccination against diphtheria, tetanus, pertussis, hepatitis B and Hib disease since the conclusion visit of the 101223 study.
* History of diphtheria, tetanus, pertussis, hepatitis B and Hib disease.
* Known exposure to diphtheria, tetanus, pertussis, hepatitis B and Hib disease since the conclusion visit of the 101223 study.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
* Major congenital defects or serious chronic illness.
* History of any neurologic disorders or seizures.
* Acute disease at the time of enrolment.
* Administration of immunoglobulins and/or any blood products during the study period.
* Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.
* One of the following adverse events that constitute absolute contraindications to further administration of DTP vaccine, having occurred after previous administration of DTPw vaccine.

  * Known hypersensitivity to any component of the vaccine, or having shown signs of hypersensitivity after previous administration of diphtheria, tetanus, pertussis or HB vaccines.
  * Encephalopathy
  * Axillary temperature of \>= 40 °C/ rectal temperature \>= 40.5 °C within 48 hours of vaccination.
  * Collapse or shock-like state within 48 hours of vaccination.
  * Persistent, inconsolable crying lasting \>= 3 hours occurring within 48 hours of vaccination.
  * Seizures with or without fever occurring within 3 days of vaccination.

Primary outcomes:
measure: Anti-polyribosyl-ribitol-phosphate (PRP) antibody concentration
timeFrame: One month after the booster dose
measure: Anti-hepatitis B surface antigen (HBs) antibody concentration
timeFrame: One month after the booster dose
measure: Anti-diphtheria antibody concentration
timeFrame: One month after the booster dose
measure: Anti-tetanus antibody concentration
timeFrame: One month after the booster dose
Secondary outcomes:
measure: Anti-Bordetella pertussis (BPT) antibody concentration
timeFrame: One month after the booster dose
measure: Anti-PRP antibody concentration
timeFrame: Prior to the booster dose
measure: Anti-HBs antibody concentration
timeFrame: Prior to the booster dose
measure: Anti-diphtheria antibody concentration
timeFrame: Prior to the booster dose
measure: Anti-tetanus antibody concentration
timeFrame: Prior to the booster dose
measure: Anti-BPT antibody concentration
timeFrame: Prior to the booster dose
measure: Occurrence of solicited symptoms
timeFrame: During the 4-day follow-up period after the booster dose
measure: Occurrence of unsolicited symptoms
timeFrame: During the 31-day follow-up period after the booster dose
measure: Occurrence of serious adverse events
timeFrame: During the entire study period.
Other outcomes:
Locations:
city: Capital Federal
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: Leon
country: Nicaragua
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Espinoza F, Tregnaghi M, Gentile A, Abarca K, Casellas J, Collard A, Lefevre I, Jacquet JM. Primary and booster vaccination in Latin American children with a DTPw-HBV/Hib combination: a randomized controlled trial. BMC Infect Dis. 2010 Oct 15;10:297. doi: 10.1186/1471-2334-10-297.