Status:
COMPLETED
A Study in Children With Different Formulations of GSK Biologicals' 11 Valent Pneumococcal Conjugate Vaccine
Lead Sponsor:
GlaxoSmithKline
Conditions:
Streptococcal Infections
Eligibility:
All Genders
8-16 years
Phase:
PHASE2
Brief 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 vaccina...
Detailed 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
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2005
Estimated Enrollment :
689 Patients enrolled
Trial Details
Trial ID
NCT00169481
Start Date
October 1 2004
End Date
May 1 2005
Last Update
January 10 2017
Active Locations (56)
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1
GSK Investigational Site
Bad Saulgau, Baden-Wurttemberg, Germany, 88348
2
GSK Investigational Site
Bretten, Baden-Wurttemberg, Germany, 75015
3
GSK Investigational Site
Eppelheim, Baden-Wurttemberg, Germany, 69214
4
GSK Investigational Site
Ettenheim, Baden-Wurttemberg, Germany, 77955