A Phase 3 interventional study of Pediacel® and Infanrix™-IPV/Hib in Infant Immunizations, sponsored by Dalhousie University. Completed at 2 sites in Canada. Open to participants aged 42 Days to 3 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-06-15.
Sponsored by Dalhousie University · Phase 3, Interventional, and Prevention
To demonstrate the safety and immunogenicity of two mixed primary immunization schedules: Pediacel® at 2 and 4 months of age followed by one dose of Infanrix™ IPV/Hib at 6 months of age; and, Infanrix™ IPV/Hib at 2 months of age, followed by Pediacel® at 4 and 6 months of age.
Immunogenicity will be evaluated using the following:
Serological outcome measures will be assessed on day 0 (visit 1) and 28-42 days after the 3rd dose of the primary series for both groups:
Safety will be evaluated using the following:
Dalhousie University is the lead sponsor of 50 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Pediacel® at 2 and 4 months of age followed by Infanrix™-IPV/Hib at 6 months.
Biological: Pediacel® and Infanrix™-IPV/Hib
Infanrix™-IPV/Hib at 2 months of age followed by Pediacel® at 4 and 6 months.
Biological: Pediacel® and Infanrix™-IPV/Hib
0.5 mL IM at 2,4 and 6 months of age
Descriptive statistics will be used to summarize the safety and immunogenicity of the two mixed primary immunization schedules.
Time frame: serology at 2 and 7 months of age
This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.
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Dalhousie University