Last updated: 11/03/2018 09:08:16
Long-term persistence study to assess a booster dose of GSK Biologicals’ Hib-MenC
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Phase III, open, multicenter Study to Assess the Long-Term Persistence of a Booster Dose of GSK Biologicals' Hib-MenC compared to a Booster Dose of Infanrix™ Hexa When Given to 14 month-old Subjects Primed in study DTPa-HBV-IPV-097 & Boosted in study Hib-MenC-TT-010 BST: DTPa-HBV-IPV-097
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
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
Timeframe: 18, 30, 42, 54 and 66 months after booster dose (day 0)
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
Timeframe: 18, 30, 42, 54 and 66 months after booster dose (day 0)
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
Timeframe: 18, 30, 42, 54 and 66 months after booster dose (day 0)
rSBA-MenC Titers
Timeframe: 18, 30, 42, 54 and 66 months after booster dose (day 0)
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)
Timeframe: 18, 30, 42, 54 and 66 months after the booster dose (day 0)
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)
Timeframe: 18, 30, 42, 54 and 66 months after the booster dose (day 0)
Anti-PRP Concentrations
Timeframe: 18, 30, 42, 54 and 66 months after the booster dose (day 0)
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)
Timeframe: 18, 30, 42, 54 and 66 months after the booster dose (day 0)
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)
Timeframe: 18, 30, 42, 54 and 66 months after the booster dose (day 0)
Anti-PSC Concentrations
Timeframe: 18, 30, 42, 54 and 66 months after the booster dose (day 0)
Number of Subjects With Serious Adverse Events
Timeframe: From last study contact of the booster study (NCT00323050) to Month 66 after booster dose (day 0)
Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: Haemophilus influenzae type b- and meningococcal (vaccine)
Biological/vaccine: Infanrix™ penta
Biological/vaccine: Infanrix™ hexa
Biological/vaccine: Engerix-B
Biological/vaccine: NeisVac-C™
Biological/vaccine: Infanrix™ IPV/HIB
Biological/vaccine: Meningitec™
Enrollment:
230
Observational study model:
Not applicable
Primary completion date:
2006-28-07
Time perspective:
Not applicable
Clinical publications:
Tejedor JC et al. (2008) Immunogenicity and Reactogenicity of a Booster Dose of a Novel Combined Haemophilus influenzae Type b-Neisseria meningitidis Serogroup C-Tetanus Toxoid Conjugate Vaccine Given to Toddlers of 13–14 Months of Age With Antibody Persistence Up to 31 Months of Age. Pediatr Infect Dis J. 27(7): 579–588.
Tejedor JC et al. (2012) Five-year antibody persistence and safety following a booster dose of combined Haemophilus influenzae type B-Neisseria meningitidis serogroup C-tetanus toxoid conjugate vaccine. Pediatr Infect Dis J. 31(10):1074–1077.
Tejedor JC et al. Antibody persistence 54 months after a booster dose of combined Haemophilus influenzae type b-Neisseria meningitidis serogroup C-tetanus-toxoid (HibMenC-TT) conjugate vaccine. Abstract presented at the 29th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID). The Hague, The Netherlands, 7-11 June 2011.
Tejedor JC et al. Antibody persistence 66 months after a booster dose of combined Haemophilus influenzae type B-Neisseria meningitidis serogroup C-tetanus-toxoid (Hib-MenC-TT) conjugate vaccine. Abstract presented at the 30th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID), Thessaloniki, Greece, 8-12 May 2012.
Medical condition
Haemophilus influenzae type b, Neisseria Meningitidis
Product
SB811936
Collaborators
Not applicable
Study date(s)
May 2006 to July 2006
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
31 - 33 months
Accepts healthy volunteers
Yes
- 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.
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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)
Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
Exclusion criteria:
- History of H. influenzae type b, meningococcal serogroup C diseases.
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.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2006-28-07
Actual study completion date
2006-28-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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