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

October 5, 2009
June 14, 2011
May 2010
July 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00990080 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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:

  • 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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Infant Immunizations
Biological: Pediacel® and Infanrix™-IPV/Hib
0.5 mL IM at 2,4 and 6 months of age
  • Active Comparator: Group 1
    Pediacel® at 2 and 4 months of age followed by Infanrix™-IPV/Hib at 6 months.
    Intervention: Biological: Pediacel® and Infanrix™-IPV/Hib
  • Active Comparator: Group 2
    Infanrix™-IPV/Hib at 2 months of age followed by Pediacel® at 4 and 6 months.
    Intervention: Biological: Pediacel® and Infanrix™-IPV/Hib
Langley JM, Halperin SA, Rubin E, White C, McNeil S, Mutch J, Mackinnon-Cameron D, Smith B. Safety and immunogenicity of 2 mixed primary infant immunization schedules of pentavalent diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, and Haemophilus influenzae Type B vaccines at 2, 4, and 6 months of age: a randomized controlled trial. Pediatr Infect Dis J. 2012 Feb;31(2):189-92. doi: 10.1097/INF.0b013e318242462a.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
253
January 2011
July 2010   (final data collection date for primary outcome measure)

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.
Both
42 Days to 3 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00990080
SP91
No
Dr Joanne Langley, Canadian Center for Vaccinology
Dalhousie University
  • IWK Health Centre
  • Sanofi Pasteur MSD
Principal Investigator: Joanne Langley, MD Dalhousie University
Dalhousie University
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP