Status:
COMPLETED
Primary & Booster Study in Infants to Demonstrate Non-inferiority, Persistence & Immunogenicity of Hib-MenC Vaccine
Lead Sponsor:
GlaxoSmithKline
Conditions:
Neisseria Meningitidis
Haemophilus Influenzae Type b
Eligibility:
All Genders
6-12 years
Phase:
PHASE3
Brief Summary
The purpose of this primary vaccination phase is to demonstrate the non-inferiority of two doses of Biologicals' Hib-MenC conjugate vaccine when given with Infanrix™ penta to infants (at 3 \& 5m) comp...
Detailed Description
This multicenter study is open and consists of a primary and a booster phase. The study has 2 treatment groups with NeisVac-C™ + Infanrix™ hexa as active controls. In the primary phase, one blood samp...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Primary Phase:
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- healthy male or female subject between, and including, 6 and 12 weeks of age at the time of the first vaccination, born after a gestation period between and including 36 and 42 weeks.
- Written informed consent obtained from the parent or guardian of the subject prior to the study entry.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Booster Phase:
- • Participation in primary phase of study.
- Exclusion Criteria
- Primary Phase:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) since birth or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressant or other immune-modifying drugs since birth.
- Planned administration/ administration of a vaccine not foreseen by the study protocol since birth, with exception of BCG.
- Previous vaccination against meningococcal serogroup C disease, diphtheria, tetanus, pertussis, polio, pneumococcal, Hepatitis B or Hib disease
- History of Haemophilus influenzae type b and /or meningococcal serogroup C disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
- A family history of congenital or hereditary immunodeficiency.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Additional Exclusion criteria for the Booster Phase:
- • Previous booster vaccination with Hib and/or MenC and/or DTP containing and/or IPV containing and/or HepB containing vaccine(s).
Exclusion
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
709 Patients enrolled
Trial Details
Trial ID
NCT00327184
Start Date
April 1 2006
End Date
November 1 2006
Last Update
October 7 2016
Active Locations (16)
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1
GSK Investigational Site
Espoo, Finland, 02100
2
GSK Investigational Site
Helsinki, Finland, 00100
3
GSK Investigational Site
Helsinki, Finland, 00930
4
GSK Investigational Site
Jarvenpaa, Finland, 04400