Primary & Booster Study in Infants to Demonstrate Non-inferiority, Persistence & Immunogenicity of Hib-MenC Vaccine

Study Overview
=================
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) compared to NeisVac-C™ given with Infanrix™ hexa. The purpose of the booster vaccination phase is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of the Hib-MenC vaccine given with Infanrix™ penta at 11 m of age versus NeisVac-C™ given with Infanrix™ hexa, as well as the antibody persistence prior to the administration of the booster doses. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

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 sample will be collected from all subjects for immunogenicity analyses- one month after the second vaccination dose. In the booster phase, two blood samples will be collected: prior to and one month post booster vaccination.

Official Title
-----------------
Study to Demonstrate Non-inferiority of GSK Biologicals' Hib-MenC Given With Infanrix™ Penta Versus NeisVac-C™ Given With Infanrix™ Hexa at 3, 5 Months of Age and Persistence Prior to a Hib-MenC Booster at 11 Months and Immunogenicity of the Booster

Conditions
-----------------
Neisseria Meningitidis, Haemophilus Influenzae Type b

Intervention / Treatment
-----------------
* Biological: Haemophilus influenzae type b- and meningococcal serogroup C (vaccine)
* Biological: Infanrix Penta
* Biological: Infanrix hexa
* Biological: Neis-Vac-C


Participation Criteria
=================
Eligibility Criteria
-----------------
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).

Ages Eligible for Study
-----------------
Minimum Age: 6 Weeks
Maximum Age: 12 Weeks

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group Hib-MenC<br>Subjects receive 2 primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age of Hib-MenC + Infanrix™ penta vaccines. | Biological: Haemophilus influenzae type b- and meningococcal serogroup C (vaccine)<br>* Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age.<br>Biological: Infanrix Penta<br>* Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age.<br>|
| Active Comparator: Group NeisVac-C<br>Subjects receive 2 primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age of NeisVac-C™ + Infanrix™ hexa vaccines. | Biological: Infanrix hexa<br>* Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age<br>Biological: Neis-Vac-C<br>* Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SBA-MenC titre |  | One month after the second dose of the Primary Vaccination Phase. | 
| Anti-PRP concentration |  | One month after the second dose of the Primary Vaccination Phase | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SBA-MenC titres |  | One month after the second dose of the Primary Vaccination Phase; prior to and one month after the Booster Vaccination | 
| Anti-PRP concentrations |  | One month after the second dose of the Primary Vaccination Phase; prior to and one month after the Booster Vaccination | 
| Anti-PSC concentrations |  | One month after the second dose of the Primary Vaccination Phase; prior to and one month after the Booster Vaccination. | 
| Anti-HBs concentrations |  | One month after the second dose of the Primary Vaccination Phase; prior to and one month after the Booster Vaccination | 
| Occurrence of local solicited adverse events. |  | During the solicited follow-up period (Day 0 - Day 3) following the administration of each vaccine dose. | 
| Occurrence of solicited general adverse events |  | During the solicited follow-up period (Day 0 - Day 3) following the administration of each vaccine dose. | 
| Occurrence of unsolicited non-serious adverse events |  | Within 30 days after each vaccination | 
| Occurrence of any serious adverse events |  | Throughout the study. |