Phase 3
Completed N=184
Long-term Persistence Study to Assess a Booster Dose of GSK Biologicals' Hib-MenC
Source: ClinicalTrials.gov NCT00322335 ↗Enrolled (actual)
184
Serious AEs
0.0%
Results posted
Jan 2011
Primary outcomePrimary: Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:8 — 44; 93; 0; 39 subjects
Summary
This protocol posting deals with objectives & outcome measures of the extension phase at Months 18, 30, 42, 54 and 66 post booster. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00352963). The objectives & outcome measures of the Booster phase/study are presented in a separate protocol posting (NCT number =NCT00323050).
The purpose of this study is to evaluate the persistence of meningococcal serogroup C and Hib antibodies on a yearly basis for a period of 5.5 years after booster vaccination. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:8 |
44; 93; 0; 39; 96; 31 | — |
| PRIMARY Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:32 |
40; 93; 0; 36; 94; 25 | — |
| PRIMARY Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:128 |
27; 82; 0; 27; 80; 12 | — |
| PRIMARY rSBA-MenC Titers |
221.5; 801.1; 0; 109.1; 441.7; 40.3 | — |
| PRIMARY Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 0.15 µg/mL (Microgram Per Milliliter) |
56; 121; 3; 53; 112; 53 | — |
| PRIMARY Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 1.0 µg/mL (Microgram Per Milliliter) |
44; 112; 3; 36; 98; 40 | — |
| PRIMARY Anti-PRP Concentrations |
2.921; 5.450; 2.547; 1.914; 3.524; 2.224 | — |
| PRIMARY Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 0.3 µg/mL (Microgram Per Milliliter) |
38; 100; 0; 19; 58; 19 | — |
| PRIMARY Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 2.0 µg/mL (Microgram Per Milliliter) |
1; 31; 0; 1; 18; 3 | — |
| PRIMARY Anti-PSC Concentrations |
0.50; 1.01; 0; 0.26; 0.47; 0.30 | — |
| PRIMARY Number of Subjects With Serious Adverse Events |
0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
- A male or female in their third year of life at the time of the study initiation for the subjects who enter the study at Visit 1. The subjects who enter the study at Visit 2 should be in their fourth year of life at the time of the study initiation.
- Written informed consent obtained from the parent or guardian of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Having completed the booster vaccination study Hib-MenC-TT-010 BST:DTPA-HBV-IPV-097 (NCT=00323050).
- Subjects who are part of the Meningitec™ control group and who were not enrolled at Visit 1 can be enrolled at Visit 2 if they have completed the booster vaccination study Hib-MenC-TT-010 BST:DTPA-HBV-IPV-097 (NCT=00323050) and if they have received a fourth dose of Meningitec™ in their second year of life, after the booster study Hib-MenC-TT-010 BST:DTPA-HBV-IPV-097 (NCT=00323050)
Exclusion Criteria
- Previous administration of a booster dose of Hib or meningococcal serogroup C except booster study vaccines during the study Hib-MenC-TT-010 BST:DTPA-HBV-IPV-097. Subjects who received a 4th dose of Meningitec™ should be included in the study.
- History of H. influenzae type b, meningococcal serogroup C diseases.
Data sourced from ClinicalTrials.gov (NCT00322335). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.