Trials / Completed
CompletedNCT00135486
Study to Evaluate GlaxoSmithKline (GSK) Biologicals' MenC-TT Vaccine and Hib-MenC-TT Vaccine in Infants
Evaluate Immunogenicity, Reactogenicity, Safety of GSK Biologicals' MenC-TT Vaccine (2 Formulations) Given With Infanrix Hexa® + GSK Biologicals' Hib MenC-TT Vaccine (2 Formulations) Given With Infanrix Penta® to Infants in Mths 3,4,5 of Life
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 500 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 8 Weeks – 16 Weeks
- Healthy volunteers
- Accepted
Summary
The purpose of this primary vaccination study is to evaluate the immunogenicity, safety and reactogenicity of three doses of GSK Biologicals' MenC-TT (Neisseria meningitidis group C polysaccharide-tetanus toxoid) vaccine (2 different formulations) and of three doses of GSK Biologicals' Hib-MenC-TT (Haemophilus influenzae type b-MenC-TT) vaccine (2 different formulations) when given to infants in their 3rd, 4th, and 5th months of life. Concomitant vaccines were given to all children to complete the vaccination agenda.
Detailed description
Five parallel treatment groups receiving a 3-dose primary vaccination course: MenC-TT vaccine (2 formulations, double-blind) + Infanrix hexa® OR Hib-MenC-TT (2 formulations double-blind) + Infanrix penta® OR Meningitec™ + Infanrix hexa® (control). Three blood samples taken, before dose 1 and one month after dose 2 and dose 3.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | MenC-TT | |
| BIOLOGICAL | Hib-MenC-TT |
Timeline
- Start date
- 2002-03-01
- Primary completion
- 2003-01-01
- Completion
- 2003-01-01
- First posted
- 2005-08-26
- Last updated
- 2016-09-16
Source: ClinicalTrials.gov record NCT00135486. Inclusion in this directory is not an endorsement.