This website uses cookies to enhance your browsing experience, improve site performance, and gather analytics. By selecting 'Accept,' you consent to these cookies as described in our Privacy Policy.

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

Sponsored by Dalhousie University

About this trial

Last updated 14 years ago

Study ID

SP91

Status

Completed

Type

Interventional

Phase

Phase 3

Placebo

No

Accepting

18-75 Years
42 to 3 Years
All
All

Trial Timing

Ended 15 years ago

What is this trial about?

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.

What are the participation requirements?

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.

No

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.

Locations

Location

Status