A Phase 3 interventional study of Pneumococcal (vaccine) in Infections, Streptococcal and Streptococcus Pneumoniae Vaccines, sponsored by GlaxoSmithKline. Completed at 32 sites in Germany. Open to participants aged 8 Weeks to 16 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-02.
Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention
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
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
121 studies on the registry are indexed under Pneumonia, Pneumococcal; 7 are open to participants now.
This study's enrollment of 120 is below the median of 304 across 79 interventional studies indexed under Pneumonia, Pneumococcal.
Browse Pneumonia, Pneumococcal studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
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
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
Unsolicited adverse events within 31 days, SAEs (whole study period)
Plan to share: Yes — IPD is available via the Clinical Study Data Request site (click on the link provided below)
Supporting information: Study protocol, Sap, Icf, Csr
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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