Clinical trial NCT01171989: Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine Administered as a Booster Dose
Official title: Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine Administered as a Booster Dose in 12-18 Months Old Healthy Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tetanus
Diphtheria
Haemophilus Influenzae Type b
Hepatitis B
Poliomyelitis
Acellular Pertussis
Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b-Neisseria Meni
Keywords: booster vaccination
combined vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-07-29
Enrollment: 391
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The current trial will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine when administered as a booster dose following priming in the first year of life with the same vaccine.

This protocol posting deals with objectives \& outcome measures of the booster phase. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00970307).


Eligibility criteria: Inclusion Criteria:

* Subjects who the investigator believes that parent(s)/ legally acceptable representative(s) can and will comply with the requirements of the protocol.
* Subjects who have completed the full three-dose primary vaccination course according to their group allocation in the primary study DTPa-HBV-IPV=Hib-MenC-TT-002 (112157).
* A male or female between, and including, 12 and 18 months of age at the time of booster vaccination.
* 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:

* Child in care.
* Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the 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 vaccination.
* Planned administration/administration of immunoglobulins and/or any blood products within three months before the booster dose, or during the study period.
* Planned administration/administration of any vaccine not foreseen by the study protocol during the period starting 30 days before and ending 30 days after the booster dose.
* Participation in another clinical study since the primary study DTPa-HBV-IPV/Hib-MenC-TT-002 in which the subject has been or will be exposed to an investigational or a non-investigational product.
* Evidence of previous diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Hib, pneumococcal and MenC vaccination or disease since the conclusion visit of study DTPa-HBV-IPV/Hib-MenC-TT-002.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
* The following adverse event having occurred after previous administration of DTP vaccine:

  * Encephalopathy.
  * Temperature of \>= 40.5°C (rectal temperature) within 48 hours of vaccination, not due to another identifiable cause.
  * Collapse or shock-like state within 48 hours of vaccination.
  * Persistent, inconsolable crying occurring within 48 hours of vaccination and lasting \>= 3 hours.
  * Seizures with or without fever occurring within 3 days of vaccination.

The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met:

• 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.

Primary outcomes:
measure: Number of Seroprotected Subjects Against Polyribosyl-Ribitol-Phosphate (PRP)
timeFrame: At Month 1, post-booster dose
measure: Number of Seroprotected Subjects Against Neisseria Meningitidis Serogroup C Using Baby Rabbit Completent (rSBA-MenC)
timeFrame: At Month 1, post-booster dose
Secondary outcomes:
measure: Number of Seropositive Subjects for Anti-PRP
timeFrame: At Month 0, before the booster dose
measure: Number of Subjects With Anti-PRP Antibody Concentrations ≥ the Cut-off
timeFrame: At Month 0 and Month 1, before and one month after booster dose
measure: Anti-PRP Antibody Concentrations
timeFrame: At Month 0 and Month 1, before and one month after booster dose
measure: Number of Seroprotected Subjects Against rSBA-MenC
timeFrame: At Month 0, before the booster dose
measure: Number of Seropositive Subjects for Anti-rSBA-MenC
timeFrame: At Month 0 and Month 1, before and one month after booster dose
measure: Anti-rSBA-MenC Antibody Titres
timeFrame: At Month 0 and Month 1, before and one month after booster dose
measure: Number of Subjects With Polysaccharide N. Meningitidis Serogroup C (PSC) Antibody Concentrations ≥ Cut-off Values
timeFrame: At Month 0 and Month 1, before and one month after booster dose
measure: Anti-PSC Antibody Concentrations
timeFrame: At Month 0 and Month 1, before and one month after booster dose
measure: Number of Seropositive Subjects for Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T)
timeFrame: At Month 0 and Month 1, before and one month after booster dose
measure: Anti-D and Anti-T Antibody Concentrations
timeFrame: At Month 0 and Month 1, before and one month after booster dose
measure: Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations ≥ Cut-off Values
timeFrame: At Month 0 and Month 1, before and one month after booster dose
measure: Anti-HBs Antibody Concentrations
timeFrame: At Month 0 and Month 1, before and after booster dose
measure: Number of Seropositive Subjects for Anti-poliovirus Types 1, 2 and 3
timeFrame: At Month 0 and Month 1, before and one month after booster dose
measure: Anti-poliovirus Types 1, 2 and 3 Antibody Titres
timeFrame: At Month 0 and Month 1, before and one month after booster dose
measure: Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)
timeFrame: At Month 0 and Month 1, before and one month after booster dose
measure: Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
timeFrame: At Month 0 and Month 1, before and one month after booster dose
measure: Number of Subjects With Any Solicited Local Symptoms
timeFrame: During the 8-day (Days 0-7) post-booster period
measure: Number of Subjects With Any Solicited General Symptoms
timeFrame: During the 8-day (Days 0-7) post-booster period
measure: Number of Subjects With Unsolicited Adverse Events (AEs)
timeFrame: During the 31-day (Days 0-30) post-booster period
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: After the booster dose of the study vaccine up to the study end (from Month 0 to Month 1)
Other outcomes:
Locations:
city: Bydgoszcz
country: Poland
facility: GSK Investigational Site
city: Debica
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Siemianowice Slaskie
country: Poland
facility: GSK Investigational Site
city: Tarnow
country: Poland
facility: GSK Investigational Site
city: Torun
country: Poland
facility: GSK Investigational Site
city: Trzebnica
country: Poland
facility: GSK Investigational Site
city: Wroclaw
country: Poland
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Szenborn L, Czajka H, Brzostek J, Konior R, Caubet M, Ulianov L, Leyssen M. A randomized, controlled trial to assess the immunogenicity and safety of a heptavalent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, hib and meningococcal serogroup C combination vaccine administered at 2, 3, 4 and 12-18 months of age. Pediatr Infect Dis J. 2013 Jul;32(7):777-85. doi: 10.1097/INF.0b013e31828d6b20.