CClinicalTrials.gg
CompletedNCT00990080Updated Jun 15, 2011

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

A Phase 3 interventional study of Pediacel® and Infanrix™-IPV/Hib in Infant Immunizations, sponsored by Dalhousie University. Completed at 2 sites in Canada. Open to participants aged 42 Days to 3 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-06-15.

Sponsored by Dalhousie University · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
253
Allocation
Randomized
Ages
42 Days to 3 Months
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Infant Immunizations
03

In context

Lead sponsor

Dalhousie University is the lead sponsor of 50 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
42 Days to 3 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
253 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • BiologicalPediacel® and Infanrix™-IPV/Hib

    0.5 mL IM at 2,4 and 6 months of age

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

2 sites
  • Canadian Center for Vaccinology
    Halifax, Nova Scotia B3K 6R8, Canada
  • MUHC- Vaccine Study Centre
    Pierrefonds, Quebec H9H 4Y6, Canada
08

References and documents

Publications

  • 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. PubMed 22173143 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00990080
Lead sponsor
Dalhousie University
Collaborators
IWK Health Centre, MCM Vaccines B.V.
First posted
Oct 6, 2009
Start date
May 2010
Primary completion
Jul 2010
Completion
Jan 2011
Last update
Jun 15, 2011

Study contacts

Joanne Langley, MD
principal investigator · Dalhousie University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.

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