Trials / Completed
CompletedNCT01917357
A Comparison of the Immunogenicity and Safety of Quinvaxem in Mono-dose Vials and Uniject
A Phase III, Open-label, Randomized Parallel-group Study on the Immunogenicity and Safety of Quinvaxem® DTwP-HepB-Hib) in Uniject™ With Quinvaxem® Monodose Vials in Healthy Infants at 6, 10 and 14 Weeks of Age
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 400 (actual)
- Sponsor
- Crucell Holland BV · Industry
- Sex
- All
- Age
- 42 Days – 64 Days
- Healthy volunteers
- Accepted
Summary
This is a study to show that vaccination with three doses of Quinvaxem presented in Uniject is not inferior to vaccination with three doses of Quinvaxem presented in single dose vials, with respect to protection against all antibodies (anti-hepatitis B surface antibodies, anti-polyribosyl ribitol phosphate (PRP), anti-diphtheria, anti-tetanus and anti-Bordetella pertussis) one (1) month after completion of the 6-10-14 week vaccination course.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Quinvaxem in Uniject | |
| BIOLOGICAL | Quinvaxem in single dose vials |
Timeline
- Start date
- 2013-09-01
- Primary completion
- 2014-04-01
- Completion
- 2014-04-01
- First posted
- 2013-08-06
- Last updated
- 2014-07-15
Locations
1 site across 1 country: Philippines
Source: ClinicalTrials.gov record NCT01917357. Inclusion in this directory is not an endorsement.