Interchangeability of Infanrix™ IPV/Hib and Pediacel® at 2,4 & 6 Months of Age
June 14, 2011 updated by: Dalhousie University
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
253
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3K 6R8
- Canadian Center for Vaccinology
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Quebec
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Pierrefonds, Quebec, Canada, H9H 4Y6
- MUHC- Vaccine Study Centre
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 3 months (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group 1
Pediacel® at 2 and 4 months of age followed by Infanrix™-IPV/Hib at 6 months.
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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.
|
0.5 mL IM at 2,4 and 6 months of age
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
serology at 2 and 7 months of age
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Joanne Langley, MD, Dalhousie University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (Actual)
July 1, 2010
Study Completion (Actual)
January 1, 2011
Study Registration Dates
First Submitted
October 5, 2009
First Submitted That Met QC Criteria
October 5, 2009
First Posted (Estimate)
October 6, 2009
Study Record Updates
Last Update Posted (Estimate)
June 15, 2011
Last Update Submitted That Met QC Criteria
June 14, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Other Study ID Numbers
- SP91
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.