Assess the Immunogenicity of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine
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
2 other identifiers
interventional
120
1 country
32
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2005
Shorter than P25 for phase_3
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 27, 2005
CompletedFirst Submitted
Initial submission to the registry
March 7, 2006
CompletedFirst Posted
Study publicly available on registry
March 28, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 7, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
April 7, 2006
CompletedJanuary 2, 2020
December 1, 2019
5 months
March 7, 2006
December 27, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 (6)
1 month post dose 3: For all vaccine pneumococcal serotypes: Opsono titres
Antibody (Ab) concns >= 0.05 µg/mL
Ab concns to protein D and seropositivity (S+) status
S+/seroprotection status to antigens in DTPa-HBV-IPV/Hib vaccine
After each vaccination, occurrence of: solicited local, general symptoms within 4 days
- +1 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (32)
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68167, Germany
GSK Investigational Site
Marbach, Baden-Wurttemberg, 71672, Germany
GSK Investigational Site
Nördlingen, Bavaria, 86720, Germany
GSK Investigational Site
Tutzing, Bavaria, 82327, Germany
GSK Investigational Site
Wiesbaden, Hesse, 65205, Germany
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, 18146, Germany
GSK Investigational Site
Waren, Mecklenburg-Vorpommern, 17192, Germany
GSK Investigational Site
Bad Oeynhausen, North Rhine-Westphalia, 32549, Germany
GSK Investigational Site
Erkrath, North Rhine-Westphalia, 40699, Germany
GSK Investigational Site
Goch, North Rhine-Westphalia, 47574, Germany
GSK Investigational Site
Heiligenhaus, North Rhine-Westphalia, 42579, Germany
GSK Investigational Site
Minden, North Rhine-Westphalia, 32427, Germany
GSK Investigational Site
Mönchengladbach, North Rhine-Westphalia, 41061, Germany
GSK Investigational Site
Mönchengladbach, North Rhine-Westphalia, 41236, Germany
GSK Investigational Site
Münster, North Rhine-Westphalia, 48159, Germany
GSK Investigational Site
Oberhausen, North Rhine-Westphalia, 46145, Germany
GSK Investigational Site
Willich, North Rhine-Westphalia, 47877, Germany
GSK Investigational Site
Frankenthal, Rhineland-Palatinate, 67227, Germany
GSK Investigational Site
Gerolstein, Rhineland-Palatinate, 54568, Germany
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55131, Germany
GSK Investigational Site
Trier, Rhineland-Palatinate, 54294, Germany
GSK Investigational Site
Leipzig, Saxony, 04178, Germany
GSK Investigational Site
Stollberg, Saxony, 09366, Germany
GSK Investigational Site
Bad Lobenstein, Thuringia, 07356, Germany
GSK Investigational Site
Neuhaus am Rennweg, Thuringia, 98724, Germany
GSK Investigational Site
Weimar, Thuringia, 99425, Germany
GSK Investigational Site
Berlin, 10315, Germany
GSK Investigational Site
Berlin, 12627, Germany
GSK Investigational Site
Berlin, 12679, Germany
GSK Investigational Site
Berlin, 13055, Germany
GSK Investigational Site
Berlin, 13409, Germany
GSK Investigational Site
Berlin, 14197, Germany
Related Publications (1)
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.
PMID: 21909049BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2006
First Posted
March 28, 2006
Study Start
October 27, 2005
Primary Completion
April 7, 2006
Study Completion
April 7, 2006
Last Updated
January 2, 2020
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- IPD is available via the Clinical Study Data Request site (click on the link provided below)
- Access Criteria
- Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD is available via the Clinical Study Data Request site (click on the link provided below)