A Phase II, Open (Partially Double-blind), Randomised, Controlled, Multicentre, Primary Vaccination Study to Evaluate the Immunogenicity (Including Immune Memory), Reactogenicity and Safety of Three Different Formulations of the GSK Biologicals' Combined Haemophilus Influenzae Type B-meningococcal Serogroups CY Conjugate Vaccine Given Concomitantly With Infanrix® Penta and Prevenar®, Versus ActHIB® and Meningitec® Given Concomitantly With Infanrix® Penta and Versus ActHIB® Given Concomitantly With Infanrix® Penta and Prevenar® in Infants According to a 2-4-6 Month Schedule.

简要总结

主要结局

次要结局

• Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers(Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11))
• Anti-polysaccharide C (PSC) Antibody Concentration(Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11))
• Anti-tetanus Antibody Concentrations(Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10))
• Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers(Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11))
• Anti-polysaccharide Y (PSY) Antibody Concentration(Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11))
• Anti-diphtheria Antibody Concentrations(Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10))
• Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8(Prior to vaccination (Day 0), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11))
• Number of Subjects With rSBA-MenY Titers Greater Than or Equal to 1:8(Prior to vaccination (Day 0), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11))
• Number of Subjects With Anti-polysaccharide Y (PSY) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)(Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11))
• Anti-PRP Antibody Concentration(Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11))
• Number of Subjects Seroprotected for Anti-diphtheria Antibodies(Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10))
• Number of Subjects Seroseropositive for Anti-filamentus Haemagglutinin (FHA) Antibodies(Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10))
• Number of Subjects Seroseropositive for Anti-pertactin (PRN) Antibodies(Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10))
• Number of Subjects With Anti-polysaccharide C (PSC) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)(Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11))
• Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values(Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11))
• Number of Subjects Seroprotected for Anti-tetanus Antibodies(Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10))
• Anti- PT Antibody Concentrations(Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10))
• Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course(During the 8-Day (Day 0-7) follow-up period after any vaccine dose during the primary vaccination course)
• Anti- FHA Antibody Concentrations(Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10))
• Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose(During the 8-Day (Day 0-7) follow-up period after the polysaccharide challenge dose)
• Anti-poliovirus Types 1, 2 and 3 Antibody Titers(Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10))
• Number of Subjects Reporting Serious Adverse Events During the Primary Vaccination Course(Up to one month after the 3-dose primary vaccination course (Month 5))
• Anti-PRN Antibody Concentrations(Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10))
• Number of Subjects Seroseropositive for Anti-pertussis Toxoid (PT) Antibodies(Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10))
• Anti-pneumococcal Antibody Concentrations(Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10))
• Number of Subjects Reporting Unsolicited Adverse Events During the Primary Vaccination Course(During the 31-Day (Day 0-30) follow-up period after any vaccine dose during the primary vaccination course)
• Number of Subjects Reporting Unsolicited Adverse Events After Administration of the Polysaccharide Challenge Dose(During the 31-Day (Day 0-30) follow-up period after administration of the polysaccharide challenge dose)
• Number of Subjects Reporting Serious Adverse Events After Administration of the Polysaccharide Challenge Dose(Up to one month following administration of the polysaccharide challenge dose (Month 11))
• Number of Subjects Seroprotected for Anti-hepatitis B (HBs) Antibodies(Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10))
• Anti- HBs Antibody Concentrations(Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10))
• Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies(Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10))
• Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values(Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10))