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NCT00307567 Clinical Trial

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

Hepatitis B Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00307567
Other study ID # 105555
Secondary ID
Status Completed
Phase Phase 2
First received March 7, 2006
Last updated September 22, 2016
Start date November 2005
Est. completion date March 2006

Study information
Verified date September 2016
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority Germany: Paul-Ehrlich-Institut
Study type Interventional

Clinical Trial Summary

Booster and immune memory study

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

Recruitment information / eligibility
Status Completed
Enrollment 689
Est. completion date March 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 11 Months to 18 Months
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Biological:
• Pneumococcal (vaccine)

Locations
Country Name City State
Germany GSK Investigational Site Bad Saulgau Baden-Wuerttemberg
Germany GSK Investigational Site Berlin
Germany GSK Investigational Site Berlin
Germany GSK Investigational Site Berlin
Germany GSK Investigational Site Bodenheim Rheinland-Pfalz
Germany GSK Investigational Site Bredstedt Schleswig-Holstein
Germany GSK Investigational Site Bretten Baden-Wuerttemberg
Germany GSK Investigational Site Cham Bayern
Germany GSK Investigational Site Detmold Nordrhein-Westfalen
Germany GSK Investigational Site Dortmund Nordrhein-Westfalen
Germany GSK Investigational Site Eppelheim Baden-Wuerttemberg
Germany GSK Investigational Site Erkrath Nordrhein-Westfalen
Germany GSK Investigational Site Flensburg Schleswig-Holstein
Germany GSK Investigational Site Flensburg Schleswig-Holstein
Germany GSK Investigational Site Flensburg Schleswig-Holstein
Germany GSK Investigational Site Flensburg Schleswig-Holstein
Germany GSK Investigational Site Frankenthal Rheinland-Pfalz
Germany GSK Investigational Site Heiligenhaus Nordrhein-Westfalen
Germany GSK Investigational Site Herzogenaurach Bayern
Germany GSK Investigational Site Husum Schleswig-Holstein
Germany GSK Investigational Site Kehl Baden-Wuerttemberg
Germany GSK Investigational Site Kleve-Materborn Nordrhein-Westfalen
Germany GSK Investigational Site Koenigstein Hessen
Germany GSK Investigational Site Krefeld Nordrhein-Westfalen
Germany GSK Investigational Site Lobenstein Thueringen
Germany GSK Investigational Site Loehne Nordrhein-Westfalen
Germany GSK Investigational Site Ludwigshafen Rheinland-Pfalz
Germany GSK Investigational Site Mainz Rheinland-Pfalz
Germany GSK Investigational Site Muenchen Bayern
Germany GSK Investigational Site Muenchen Bayern
Germany GSK Investigational Site Muenchen Bayern
Germany GSK Investigational Site Muenster Nordrhein-Westfalen
Germany GSK Investigational Site Neumuenster Schleswig-Holstein
Germany GSK Investigational Site Noerdlingen Bayern
Germany GSK Investigational Site Oberkirch Baden-Wuerttemberg
Germany GSK Investigational Site Offenburg Baden-Wuerttemberg
Germany GSK Investigational Site Olching Bayern
Germany GSK Investigational Site Rostock Mecklenburg-Vorpommern
Germany GSK Investigational Site Salzgitter Niedersachsen
Germany GSK Investigational Site Schoeneberg - Kuebelberg Rheinland-Pfalz
Germany GSK Investigational Site Schwaebisch-Hall Baden-Wuerttemberg
Germany GSK Investigational Site Stuttgart Baden-Wuerttemberg
Germany GSK Investigational Site Tauberbischofsheim Baden-Wuerttemberg
Germany GSK Investigational Site Trier Rheinland-Pfalz
Germany GSK Investigational Site Trier Rheinland-Pfalz
Germany GSK Investigational Site Waren Mecklenburg-Vorpommern
Germany GSK Investigational Site Weilheim Bayern
Germany GSK Investigational Site Weimar Thueringen
Germany GSK Investigational Site Wiesbaden Hessen
Germany GSK Investigational Site Wolfenbuettel Niedersachsen
Germany GSK Investigational Site Worms Rheinland-Pfalz

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Pre&post booster: All vaccine pneumococcal serotypes: Opsono titres*
Secondary Antibody (Ab) concentrations >= 0.05, 0.20 µg/mL
Secondary Ab concentrations to protein D & seropositivity (S+) status
Secondary S+/seroprotection status to antigens in DTPa-HBV-IPV/Hib vaccine
Secondary Occurrence of: solicited local*,general *symptoms within 4 d
Secondary Unsolicited adverse events* within 31 d, SAEs (whole study period) *only post booster
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