Immunogenicity & Safety Study of Combined/Separate Vaccine(s) Against Common Diseases in Infants (2,4,6 Months of Age).

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the immunogenicity of the co-administration of different combinations of DTPa, IPV, hepatitis B, Hib and Men C vaccines during the first year of life.

Official Title
-----------------
Study to Assess Immunogenicity and Reactogenicity of Three Doses of GSK Bio's Combined Hib-MenC Vaccine Co-admind With GSK Bio's DTPa-HBV-IPV Vaccine and of Two Doses of Baxters Meningococcal C Conjugate Vaccine Co-admind With GSK Bio's DTPa-HBV-IPV/Hib Vaccine

Conditions
-----------------
Poliomyelitis, Tetanus, Acellular Pertussis, Hepatitis B, Diphtheria

Intervention / Treatment
-----------------
* Biological: Study vaccines: IH+Hib-MenC/NVC; Control: IH+Meningitec


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or female infant between, & including, 0 & 7 days of age at the time of the inclusion. Born after a normal gestation period (between 36 & 42 weeks). Written informed consent obtained from the parent/guardian of the subject. Exclusion Criteria: Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) or planned use during the study period. Administration of immunosuppressants or other immune-modifying drugs from birth. Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. Administration / planned administration of a vaccine not foreseen by the study protocol during the period starting from birth and ending 30 days after the last dose except BCG vaccination if given before the 30-day period preceding the administration of the 1st dose of Infanrix penta™ or Infanrix hexa™ in combination with a meningococcal C vaccine. Evidence of previous or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B, meningococcal C and Hib disease. Evidence of previous diphtheria, tetanus, pertussis, polio, hepatitis B, meningococcal C and Hib vaccination.

Ages Eligible for Study
-----------------
Maximum Age: 7 Days

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

| Intervention/Treatment |
| --- |
|Biological: Study vaccines: IH+Hib-MenC/NVC; Control: IH+Meningitec|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| At M7: Antibodies to PRP, MenC HBsAg |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| At M7: Abs. to all vaccine antigens |  |  | 
| At M6: Abs. to PRP & MenC |  |  | 
| Solicited (D0-3); unsol. events (D0-30); SAEs (full study) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Open, phase 3, Infanrix hexa™, Hib-MenC, co-administered