Clinical trial NCT01106092: Study to Evaluate the Immunogenicity and Reactogenicity of a Booster Dose of GSK2036874A Vaccine in Healthy Toddlers
Official title: Immunogenicity and Reactogenicity of a Booster Dose of GlaxoSmithKline Biologicals' GSK2036874A Vaccine in Healthy Toddlers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Haemophilus Influenzae Type b
Tetanus
Hepatitis B
Whole Cell Pertussis
Diphtheria
Poliomyelitis Vaccines
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-04-19
Enrollment: 312
Sex: ALL
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to assess the immunogenicity and safety of three formulations of GSK Biologicals' GSK2036874A vaccine compared to Zilbrix™/Hib and Poliorix™ vaccines administered concomitantly, when administered as a single booster dose to healthy poliovirus-primed toddlers aged 12-24 months.

Detailed description: The study will be conducted in a partially double-blinded manner. The study will be double-blinded with respect to the three GSK2036874A formulation groups and open-label with respect to the Control Group.

Eligibility criteria: Inclusion Criteria:

* A male or female subject, between and including 12 and 24 months of age at the time of booster vaccination.
* Subjects who have received three doses of polio vaccine as primary vaccination along with the routine vaccinations indicated during the first year of life.
* Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative (s) can and will comply with the requirements of the protocol.
* Written informed consent obtained from the parent(s)/Legally Acceptable Representative (s) 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 other than the study vaccine(s) 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 dose.
* Administration of a vaccine not foreseen by the study protocol within 30 days prior to booster vaccination, or planned administration during the active study period (up to Visit 2).
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
* History of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and/or Haemophilus influenza type b diseases.
* Previous booster vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or H. influenzae diseases.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
* A family history of congenital or hereditary immunodeficiency.
* Major congenital defects or serious chronic illness.
* History of neurologic disorders or seizures.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
* Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
* Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.
* Child in care.
* Occurrence of any of the following adverse events after a previous administration of a diphtheria-tetanus-pertussis vaccine:

  * encephalopathy of unknown aetiology occurring within seven days following previous vaccination with pertussis-containing vaccine,
  * fever \>= 40 °C within 48 hours of vaccination not due to another identifiable cause,
  * collapse or shock-like state within 48 hours of vaccination,
  * convulsions with or without fever, occurring within 3 days of vaccination.
* Acute disease and/or fever at the time of enrolment.

  * Fever is defined as temperature \>= 37.5°C on oral, axillary or tympanic setting, or \>= 38.0°C on rectal setting.
  * Subjects with a minor illness without fever may, be enrolled at the discretion of the investigator.
* Other conditions which, in the opinion of the investigator, may potentially interfere with interpretation of study results.

Primary outcomes:
measure: Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3
timeFrame: One month after booster vaccination (At Month 1)
measure: Anti-polio Types 1, 2 and 3 Antibody Titers
timeFrame: Prior to booster vaccination (At Month 0)
measure: Anti-polio Types 1, 2 and 3 Antibody Titers
timeFrame: One month after booster vaccination (At Month 1)
Secondary outcomes:
measure: Number of Seroconverted Subjects for Anti-polio Types 1, 2 and 3
timeFrame: One month after booster vaccination (At Month 1)
measure: Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3
timeFrame: Prior to booster vaccination (At Month 0)
measure: Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T)
timeFrame: Prior to (At Month 0) and one month after booster vaccination (At Month 1)
measure: Anti-D and Anti-T Antibody Concentrations
timeFrame: Prior to (At Month 0) and one month after booster vaccination (At Month 1)
measure: Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B (Anti-HBs)
timeFrame: Prior to (At Month 0) and one month after the booster vaccination (At Month 1)
measure: Anti-HBs Antibody Concentrations
timeFrame: Prior to (At Month 0) and one month after the booster vaccination (At Month 1)
measure: Number of Seroprotected Subjects Against Polyribosil-ribitol-phosphate (PRP)
timeFrame: Prior to (At Month 0) and one month after booster vaccination (At Month 1)
measure: Anti-PRP Antibody Concentrations
timeFrame: Prior to (At Month 0) and one month after booster vaccination (At Month 1)
measure: Number of Seropositive Subjects for Anti-Bordetella Pertussis (Anti-BPT)
timeFrame: Prior to (At Month 0) and one month after the booster vaccination (At Month 1)
measure: Anti-BPT Antibody Concentrations
timeFrame: Prior to (At Month 0) and one month after booster vaccination (At Month 1)
measure: Number of Subjects With a Booster Response for Anti-BPT
timeFrame: One month after booster vaccination (At Month 1)
measure: Number of Subjects With Any Solicited Local Symptoms
timeFrame: During the 8-day (Days 0-7) post-vaccination period
measure: Number of Subjects With Any Solicited General Symptoms
timeFrame: During the 8-day (Days 0-7) post-vaccination period
measure: Number of Subjects With Any Unsolicited Adverse Events (AEs)
timeFrame: During the 31-day (Day 0-Day 30) post-vaccination period
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: During the entire study period (from Month 0 to Month 1)
Other outcomes:
Locations:
city: Muntinlupa
country: Philippines
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Quiambao B, Van Der Meeren O, Kolhe D, Gatchalian S. A randomized, dose-ranging assessment of the immunogenicity and safety of a booster dose of a combined diphtheria-tetanus-whole cell pertussis-hepatitis B-inactivated poliovirus-Hemophilus influenzae type b (DTPw-HBV-IPV/Hib) vaccine vs. co-administration of DTPw-HBV/Hib and IPV vaccines in 12 to 24 months old Filipino toddlers. Hum Vaccin Immunother. 2012 Mar;8(3):347-54. doi: 10.4161/hv.18630. Epub 2012 Feb 14.
citation: Quiambao B et al. The immunogenicity and safety of a new combined DTPw-HBV-IPV/HIB vaccine when administered as a booster dose in Filipino toddlers. Abstract presented at the 7th World Congress for World Society for Pediatric Infectious Diseases (WSPID), Melbourne, Australia, 16-19 November 2011.