Interchangeability of Infanrix™ IPV/Hib and Pediacel® at 2,4 & 6 Months of Age
This study has been completed.
Sponsor:
Dalhousie University
Collaborators:
IWK Health Centre
Sanofi Pasteur MSD
Information provided by:
Dalhousie University
ClinicalTrials.gov Identifier:
NCT00990080
First received: October 5, 2009
Last updated: June 14, 2011
Last verified: June 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Infant Immunizations |
Biological: Pediacel® and Infanrix™-IPV/Hib |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Dalhousie University:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 253 |
| Study Start Date: | May 2010 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Group 1
Pediacel® at 2 and 4 months of age followed by Infanrix™-IPV/Hib at 6 months.
|
Biological: Pediacel® and Infanrix™-IPV/Hib
0.5 mL IM at 2,4 and 6 months of age
|
|
Active Comparator: Group 2
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
|
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.
Eligibility| Ages Eligible for Study: | 42 Days to 3 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Infants aged 6 wks (42 days) to 2 months (1 day before they turn 3 months) inclusive on the day of inclusion.
- Born at full term of pregnancy (defined as ≥37 weeks, 0 days).
- Informed consent form signed by the parent(s) or legally authorized representative.
- Able to attend all scheduled visits and to comply with the study procedures.
- Parent or legally authorized representative has access to a telephone.
- Parent or legally authorized representative able to read and write in English or French.
Exclusion Criteria:
- Participation in another clinical trial in the 4 weeks preceding the first trial vaccination.
- Planned participation in another clinical trial during the present trial period.
- Personal history of congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy.
- Known or suspected systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances as the trial vaccine(s).
- Chronic illness that could interfere with trial conduct or completion.
- Received blood or blood-derived products since birth.
- Any vaccination preceding the first trial vaccination, except vaccinations recommended as part of the infant schedule.
- Previous vaccination with any acellular pertussis- (DTaP) or whole cell pertussis-DTwP) based combination vaccines, Haemophilus influenzae type b Hib)conjugate,or poliovirus vaccines.
- Coagulation disorder contraindicating intramuscular vaccination.
- Clinically significant findings on review of systems (determined by investigator or sub-investigator to be sufficient for exclusion).
- Developmental delay or neurological disorder.
- Any condition which, in the opinion of the investigator, would interfere with the evaluation of the vaccine or pose a health risk to the subject.
- History of Hib, diphtheria, tetanus, pertussis or poliovirus disease.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00990080
Locations
| Canada, Nova Scotia | |
| Canadian Center for Vaccinology | |
| Halifax, Nova Scotia, Canada, B3K 6R8 | |
| Canada, Quebec | |
| MUHC- Vaccine Study Centre | |
| Pierrefonds, Quebec, Canada, H9H 4Y6 | |
Sponsors and Collaborators
Dalhousie University
IWK Health Centre
Sanofi Pasteur MSD
Investigators
| Principal Investigator: | Joanne Langley, MD | Dalhousie University |
More Information
No publications provided by Dalhousie University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dr Joanne Langley, Canadian Center for Vaccinology |
| ClinicalTrials.gov Identifier: | NCT00990080 History of Changes |
| Other Study ID Numbers: | SP91 |
| Study First Received: | October 5, 2009 |
| Last Updated: | June 14, 2011 |
| Health Authority: | Canada: Health Canada |
ClinicalTrials.gov processed this record on May 19, 2013