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 Menitorix™, given at 12-15 months of age. The children had previously received 3 doses of Menitorix™ and Infanrix IPV™ or Meningitec™ and Pediacel™ 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)
Age range
24 Months – 64 Months
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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