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

This study has been completed.
Sponsor:
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
  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:

  1. Infants aged 6 wks (42 days) to 2 months (1 day before they turn 3 months) inclusive on the day of inclusion.
  2. Born at full term of pregnancy (defined as ≥37 weeks, 0 days).
  3. Informed consent form signed by the parent(s) or legally authorized representative.
  4. Able to attend all scheduled visits and to comply with the study procedures.
  5. Parent or legally authorized representative has access to a telephone.
  6. Parent or legally authorized representative able to read and write in English or French.

Exclusion Criteria:

  1. Participation in another clinical trial in the 4 weeks preceding the first trial vaccination.
  2. Planned participation in another clinical trial during the present trial period.
  3. Personal history of congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy.
  4. 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).
  5. Chronic illness that could interfere with trial conduct or completion.
  6. Received blood or blood-derived products since birth.
  7. Any vaccination preceding the first trial vaccination, except vaccinations recommended as part of the infant schedule.
  8. Previous vaccination with any acellular pertussis- (DTaP) or whole cell pertussis-DTwP) based combination vaccines, Haemophilus influenzae type b Hib)conjugate,or poliovirus vaccines.
  9. Coagulation disorder contraindicating intramuscular vaccination.
  10. Clinically significant findings on review of systems (determined by investigator or sub-investigator to be sufficient for exclusion).
  11. Developmental delay or neurological disorder.
  12. 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.
  13. History of Hib, diphtheria, tetanus, pertussis or poliovirus disease.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 22, 2014