Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00169481
Other study ID # 103488
Secondary ID
Status Completed
Phase Phase 2
First received September 12, 2005
Last updated January 9, 2017
Start date October 2004
Est. completion date May 2005

Study information

Verified date January 2017
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority Germany: Paul-Ehrlich-Institut
Study type Interventional

Clinical Trial Summary

Three dose primary vaccination with 11-valent pneumococcal conjugate vaccine administered concomitantly with Infanrix™ hexa to healthy infants between 8 to 16 weeks of age at the time of first vaccination.


Description:

Test groups: 9 groups receiving different formulations of 11PN-PD-DiT vaccine + DTPa-HBV-IPV/Hib (Infanrix™ hexa) Comparator: 11Pn-PD + Infanrix™ hexa Control: Prevenar® + Infanrix™ hexa


Recruitment information / eligibility

Status Completed
Enrollment 689
Est. completion date May 2005
Est. primary completion date May 2005
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Weeks to 16 Weeks
Eligibility Inclusion criteria:

- Male or female aged 8-16 weeks at the time of first vaccination, written informed consent obtained from the parent/guardian of subject.

Exclusion criteria:

- Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceeding 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 30 days before the first dose of vaccine(s) and ending 30 days after the last dose.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), 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 Bochum Nordrhein-Westfalen
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 Ettenheim Baden-Wuerttemberg
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 Hamburg
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 Marburg/Lahn Hessen
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
Germany GSK Investigational Site Zwiesel Bayern

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 1 month after d3, antibody concentrations to pneumo. serotypes 1,3,4,5,6B,7F,9V,14,18C,19Fand23F.Occurrence of: solicited local and general symptoms within 8 days after each vaccination; unsolicited adverse events within 31 days after each vaccination 1 Month after dose 3 No
Secondary 1 month post d3: For pneumo.serotypes 1,3,4,5,6B,7F, 9V,14,18C,19F,23F:Opsono titres;antibody concentrations (AbC) >= 0.20 µg/mL;AbC to protein D and seropositivity (S+)status; S+/seroprotection status to antigens in Infanrix hexa. 1 Month after dose 3 No
See also
  Status Clinical Trial Phase
Completed NCT02052973 - Efficacy of Propolis Varnish Against Oral Biofilm Phase 1/Phase 2
Completed NCT01412801 - Magnitude of the Antibody Response to and Safety of a GBS Trivalent Vaccine in HIV Positive and HIV Negative Pregnant Women and Their Offsprings Phase 2
Completed NCT00884728 - Evaluation of a Regional Healthy Skin Program in Remote Aboriginal Communities of Australia's Northern Territory N/A
Completed NCT01193920 - Safety and Immunogenicity of a Group B Streptococcus Vaccine in Non Pregnant and Pregnant Women 18-40 Years of Age Phase 1/Phase 2
Terminated NCT00261742 - Comparative Trial of Oral Penicillin Versus Cefuroxim for Treatment of Perianal Streptococcal Dermatitis Phase 4
Completed NCT02270944 - Safety and Immunogenicity of the Liquid Formulation of Group B Streptococcus Trivalent Vaccine and of the Lyophilized Formulation of Group B Streptococcus Trivalent Vaccine Phase 2
Completed NCT03055728 - Rapid Strep Testing in Children With Recent Streptococcal Pharyngitis
Withdrawn NCT00598429 - Inhaled PGE1 in Neonatal Hypoxemic Respiratory Failure Phase 2
Completed NCT01030731 - Pharmacokinetic Study,Ceftobiprole,Healthy Volunteers,Healthy Patients With End Stage Renal Disease Phase 1
Completed NCT04100772 - Phase I Clinical Trial of a Candidate PCV13 in Healthy People Aged 6 Weeks and Above Phase 1
Completed NCT01118143 - Oral Health Literacy Tailored Communication N/A
Completed NCT01026740 - Evaluation of Penetration of Ceftobiprole Into Soft Tissue Determined by Microdialysis in Healthy Volunteers Phase 1
Withdrawn NCT00330642 - Rapid Detection of Group B Streptococcus (Strep)-Labor and Delivery Study N/A
Completed NCT00299663 - Long Term Follow-up of Patients With Group A Streptococcal Infection Originating From the Genital Tract N/A
Completed NCT00646958 - Safety and Efficacy Study of Oxazolidinones to Treat Uncomplicated Skin Infections Phase 2
Completed NCT00514527 - A Study for Patients With Complicated Skin and Skin Structure Infections Phase 2
Completed NCT01026558 - A Study Evaluating the Pharmacokinetics of Ceftobiprole When Taken by Obese Patients Phase 1
Completed NCT01026636 - A Single-Dose Pharmacokinetics and Safety Study of Ceftobiprole in Pediatric Patients =3 Months to <18 Years of Age Phase 1
Completed NCT01156740 - Treatment of Group A Beta Hemolytic Streptococcal Pharyngitis in Children in Low Resource Settings N/A
Completed NCT04841369 - Phase III Clinical Trial of a Candidate PCV13 in Healthy People Aged 6 Weeks and Above (PICTPCV13i) Phase 3