Clinical trial NCT00322335: Long-term Persistence Study to Assess a Booster Dose of GSK Biologicals' Hib-MenC
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Haemophilus Influenzae Type b
Neisseria Meningitidis
Keywords: H.influenzae type b Disease
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-05-05
Enrollment: 230
Sex: ALL
Minimum age (years): 31
Maximum age (years): 33
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: This multicenter study is open. No vaccine will be administered during this persistence phase of the study. The subjects were randomized in the primary vaccination study 217744/097 (DTPa-HBV-IPV-097) and will not be further randomized in this study. The study has 3 groups with Meningitec™ primed group as control. The protocol was amended to allow for enrollment of subjects of the Meningitec™ primed control group who were boosted with Meningitec™ after the end of the booster study as per new local reccommendation in Spain.

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.

Primary outcomes:
measure: 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)
measure: 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)
measure: 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)
measure: rSBA-MenC Titers
timeFrame: 18, 30, 42, 54 and 66 months after booster dose (day 0)
measure: 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)
measure: 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)
measure: Anti-PRP Concentrations
timeFrame: 18, 30, 42, 54 and 66 months after the booster dose (day 0)
measure: 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)
measure: 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)
measure: Anti-PSC Concentrations
timeFrame: 18, 30, 42, 54 and 66 months after the booster dose (day 0)
measure: 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:
Other outcomes:
Locations:
city: Almería
country: Spain
facility: GSK Investigational Site
city: Burgos
country: Spain
facility: GSK Investigational Site
city: Gerona
country: Spain
facility: GSK Investigational Site
city: Getafe/Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Marid
country: Spain
facility: GSK Investigational Site
city: Málaga
country: Spain
facility: GSK Investigational Site
city: Móstoles/Madrid
country: Spain
facility: GSK Investigational Site
city: Valladolid
country: Spain
facility: GSK Investigational Site
city: Vélez-Málaga / Málaga
country: Spain
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Tejedor JC, Moro M, Merino JM, Gomez-Campdera JA, Garcia-del-Rio M, Jurado A, Diez-Delgado FJ, Omenaca F, Garcia-Sicilia J, Ruiz-Contreras J, Martin-Ancel A, Roca J, Boceta R, Garcia-Corbeira P, Maechler G, Boutriau D; Spanish 102547 Study Group. 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. 2008 Jul;27(7):579-88. doi: 10.1097/INF.0b013e31816b4561.
citation: Tejedor JC, Merino JM, Moro M, Navarro ML, Espin J, Omenaca F, Garcia-Sicilia J, Moreno-Perez D, Ruiz-Contreras J, Centeno F, Barrio F, Cabanillas L, Muro M, Esporrin C, De Torres MJ, Caubet M, Boutriau D, Miller JM, Mesaros N. 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. 2012 Oct;31(10):1074-7. doi: 10.1097/INF.0b013e318269433a.
citation: 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.
citation: 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.