NCT00990080

Interchangeability of Infanrix™ IPV/Hib and Pediacel® at 2,4 & 6 Months of Age

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 253 (actual)
• Sponsor: Dalhousie University · Academic / Other
• Sex: All
• Age: 42 Days – 3 Months
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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: * Seroprotection rates for antibodies against PRP (anti-PRP), defined as percentage of subjects with antibody concentrations ≥ 0.15 µg/ml and ≥ 1.0 µg/ml. * Geometric mean concentration (GMC) for antibodies against PT, FHA, PRN, and FIM. * Anti-pertussis antibody concentrations ≥4-fold rise (post-Dose 3/pre-Dose 1). Safety will be evaluated using the following: * Occurrence, time to onset, number of days of occurrence, severity and seriousness of solicited injection site reactions (tenderness, erythema, swelling) and systemic symptoms (fever, vomiting, crying abnormal, drowsiness, appetite decreased, irritability) within 8 days (Day 0 - Day 7) after each vaccination and across all vaccinations. * Occurrence, nature, time to onset, duration, severity, and relationship to vaccination of unsolicited adverse events (AE) occurring within 31 days (Day 0 -Day 30) of each vaccination. * Occurrence, nature, time to onset, duration, and relationship to vaccination of any serious adverse events (SAE) during the entire study period for all groups.

Conditions

• Infant Immunizations

Interventions

Type	Name	Description
BIOLOGICAL	Pediacel® and Infanrix™-IPV/Hib	0.5 mL IM at 2,4 and 6 months of age

Timeline

• Start date: 2010-05-01
• Primary completion: 2010-07-01
• Completion: 2011-01-01
• First posted: 2009-10-06
• Last updated: 2011-06-15

Locations

2 sites across 1 country: Canada