Clinical trial NCT00307541: Assess the Immunogenicity of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine
Official title: Phase IIIa Randomized, Controlled Study to Assess the Immunogenicity of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine, When Administered as a 3-dose Primary Immunization Course Before 6 Months of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections, Streptococcal
Streptococcus Pneumoniae Vaccines
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-03-28
Enrollment: 120
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Evaluate the immune response of GSK Biologicals' 10-valent pneumococcal conjugate vaccine one month after completion of a 3-dose primary vaccination course administered at 2, 3, 4 months of age

Detailed description: Test groups: 2 groups (60 subjects/group). 10Pn-PD-DiT group receiving GSK Biologicals' 10-valent pneumococcal conjugate vaccine + DTPa-HBV-IPV/Hib; Control group receiving Prevenar + DTPa-HBV-IPV/Hib

Eligibility criteria: Inclusion criteria:

* Male or female between, and including, 8 and 16 weeks (56-118 days) of age at the time of the first vaccination, 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 licensed vaccine not foreseen by the study protocol during the period starting from one month before the first dose of vaccine(s) and during the entire study period.

Primary outcomes:
measure: 1 month post-dose 3: Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations >= 0.20 µg/mL
Secondary outcomes:
measure: 1 month post dose 3: For all vaccine pneumococcal serotypes: Opsono titres
measure: Antibody (Ab) concns >= 0.05 µg/mL
measure: Ab concns to protein D and seropositivity (S+) status
measure: S+/seroprotection status to antigens in DTPa-HBV-IPV/Hib vaccine
measure: After each vaccination, occurrence of: solicited local, general symptoms within 4 days
measure: Unsolicited adverse events within 31 days, SAEs (whole study period)
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Marbach
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Noerdlingen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Tutzing
country: Germany
facility: GSK Investigational Site
state: Bayern
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: Bad Oeynhausen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Erkrath
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Goch
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Heiligenhaus
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Minden
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Moenchengladbach
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Moenchengladbach
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Muenster
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Oberhausen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Willich
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Frankenthal
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Gerolstein
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Mainz
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Trier
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Stollberg
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Lobenstein
country: Germany
facility: GSK Investigational Site
state: Thueringen
city: Neuhaus am Rennweg
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
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:
citation: Knuf M, Pankow-Culot H, Grunert D, Rapp M, Panzer F, Kollges R, Fanic A, Habib A, Borys D, Dieussaert I, Schuerman L. Induction of immunologic memory following primary vaccination with the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine in infants. Pediatr Infect Dis J. 2012 Jan;31(1):e31-6. doi: 10.1097/INF.0b013e3182323ac2.