The purpose of this study is to evaluate the long-term antibody persistence at 12, 24 and 48 months after the administration of a booster dose of Menitorixâ„¢, given at 12-15 months of age. The children had previously received 3 doses of Menitorixâ„¢ and Infanrix IPVâ„¢ or Meningitecâ„¢ and Pediacelâ„¢ in infancy. In addition, the antibody persistence is to be investigated in children of 40-43 months of age who received a 3-dose primary vaccination of a MenC conjugate vaccine and a Hib containing vaccine in infancy without a booster dose of MenC conjugate and Hib vaccine in the second year of life. This protocol posting deals with objectives \& outcome measures of the extension phases at 12, 24 and 48 months after the booster phase. The links to objectives and outcome measures of the primary phase \& booster phase at 12 to 15 months are provided below: https://www.gsk-studyregister.com/study/2747 (Primary phase) https://www.gsk-studyregister.com/study/2755 (Booster phase)
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Number of Subjects With Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA-MenC) Antibody Titers Equal to or Above 1:8
Timeframe: At Year 1
Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128
Timeframe: At Year 1
rSBA-MenC Antibody Titers
Timeframe: At Year 1
Number of Subjects With rSBA-MenC Antibody Titers ≥1:8
Timeframe: At Year 2
Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:8 for Meningitec+Hiberix Group
Timeframe: At Year 2
Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128
Timeframe: At Year 2
Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128 for Meningitec+Hiberix Group
Timeframe: At Year 2
rSBA-MenC Antibody Titers
Timeframe: At Year 2
rSBA-MenC Antibody Titers for Meningitec+Hiberix Group
Timeframe: At Year 2
Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:8
Timeframe: At Year 4
Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128
Timeframe: At Year 4
rSBA-MenC Antibody Titers
Timeframe: At Year 4
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibodies Equal to or Above 0.15 Micrograms Per Milliliter (µg/mL) and Equal to or Above 1 Micrograms Per Milliliter (µg/mL)
Timeframe: At Year 1
Concentration of Anti-PRP Antibodies
Timeframe: At Year 1
Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL
Timeframe: At Year 2
Number of Subjects With Anti-PRP Antibodies ≥0.15 µg/mL and ≥1 µg/mL for Meningitec+Hiberix Group
Timeframe: At Year 2
Concentration of Anti-PRP Antibodies
Timeframe: At Year 2
Concentration of Anti-PRP Antibodies for Meningitec+Hiberix Group
Timeframe: At Year 2
Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL
Timeframe: At Year 4
Concentration of Anti-PRP Antibodies
Timeframe: At Year 4
Number of Subjects With Anti-serogroup C Polysaccharide (Anti-PSC) Antibody Concentrations Equal to or Above 0.3 Micrograms Per Milliliter(µg/mL) and Equal to or Above 2 Micrograms Per Milliliter (µg/mL)
Timeframe: At Year 1
Concentration of Anti-PSC Antibodies
Timeframe: At Year 1
Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL
Timeframe: At Year 2
Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL for Meningitec+Hiberix Group
Timeframe: At Year 2
Concentration of Anti-PSC Antibodies
Timeframe: At Year 2
Concentration of Anti-PSC Antibodies for Meningitec+Hiberix Group
Timeframe: At Year 2
Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL
Timeframe: At Year 4
Concentration of Anti-PSC Antibodies
Timeframe: At Year 4
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5.0 ELISA Units Per Milliliter (EL.U/mL)
Timeframe: At Year 2
Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies
Timeframe: At Year 2
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL
Timeframe: At Year 4
Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies
Timeframe: At Year 4
Number of Subjects With Serious Adverse Events (SAEs)
Timeframe: Up to Month 12 (Booster vaccination)
Number of Subjects With SAE(s)
Timeframe: Up to Month 24 (Booster vaccination)
Number of Subjects With SAE(s)
Timeframe: Up to Month 48 (Booster vaccination)
Number of Subjects With SAE(s)
Timeframe: Within (31-Days) at Year 2