Clinical trial NCT00307567: Multicentre Booster & Immune Memory Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine or a Single Dose of 23-valent Plain Polysaccharide Vaccine in Healthy Children Aged 11-18 Mths, Previously Vaccinated in Study 103488
Official title: A Phase II, Multicentre Booster Study to Evaluate Booster Vaccination With GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine or to Evaluate the Immune Memory Following the Administration of a Single Dose of 23-valent Plain Polysaccharide Vaccine in Healthy Children, Previously Vaccinated in Infancy in the Primary Study 11PN-PD-DIT-002 (103488)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acellular Pertussis
Tetanus
Hepatitis B
Diphtheria
Haemophilus Influenzae Type b
Poliomyelitis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-03-28
Enrollment: 689
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Booster and immune memory study

Detailed description: Total: All 689 subjects enrolled in study 103488. 23PS group: Aventis Pasteurs' 23-valent polysaccharide pneumococcal vaccine (Pneumovax 23) + DTPa-HBV-IPV/Hib; 10V group: GSK Biologicals' 10-valent pneumococcal conjugate vaccine + DTPa-HBV-IPV/Hib

Eligibility criteria: Inclusion criteria: Male or female between, and including, 11-18 months of age at the time of vaccination and who previously participated in the study 11PN-PD-DIT-002 and received at least one dose of pneumococcal conjugate vaccine during the primary study, free of obvious health problems and with written informed consent obtained from the parent/guardian of the subject. Exclusion criteria: Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before the first dose of vaccine(s) and during the entire study period. Administration of any additional pneumococcal vaccine or DTPa combined vaccine since study end of 11PN-PD-DIT-002 study

Primary outcomes:
measure: 1 mth after admin. of booster dose with either GSK Biologicals' 10Pn-PD-DiT vaccine or 1 mth after admin. of single dose of unconjugated 23- valent pneumococcal polysaccharide vaccine (Pneumovax™ 23), anti-pneumococcal serotypes 1,4,5,6B,7F,9V,14,18C,
Secondary outcomes:
measure: Pre&post booster: All vaccine pneumococcal serotypes: Opsono titres*
measure: Antibody (Ab) concentrations >= 0.05, 0.20 µg/mL
measure: Ab concentrations to protein D & seropositivity (S+) status
measure: S+/seroprotection status to antigens in DTPa-HBV-IPV/Hib vaccine
measure: Occurrence of: solicited local*,general *symptoms within 4 d
measure: Unsolicited adverse events* within 31 d, SAEs (whole study period) *only post booster
Other outcomes:
Locations:
city: Bad Saulgau
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Bretten
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Eppelheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Kehl
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Oberkirch
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Offenburg
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Schwaebisch-Hall
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Stuttgart
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Tauberbischofsheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Cham
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Herzogenaurach
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Noerdlingen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Olching
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Weilheim
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Koenigstein
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Wiesbaden
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Rostock
country: Germany
facility: GSK Investigational Site
state: Mecklenburg-Vorpommern
city: Waren
country: Germany
facility: GSK Investigational Site
state: Mecklenburg-Vorpommern
city: Salzgitter
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Wolfenbuettel
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Detmold
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Dortmund
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Erkrath
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Heiligenhaus
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Kleve-Materborn
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Krefeld
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Loehne
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Muenster
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Bodenheim
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Frankenthal
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Ludwigshafen
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Mainz
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Schoeneberg - Kuebelberg
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Trier
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Trier
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Worms
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Bredstedt
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Flensburg
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Flensburg
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Flensburg
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Flensburg
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Husum
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Neumuenster
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Lobenstein
country: Germany
facility: GSK Investigational Site
state: Thueringen
city: Weimar
country: Germany
facility: GSK Investigational Site
state: Thueringen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: