Long-term Persistence Study to Assess a Booster Dose of GSK Biologicals' Hib-MenC
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
5 other identifiers
interventional
230
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2006
Typical duration for phase_3
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 4, 2006
CompletedFirst Posted
Study publicly available on registry
May 5, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedResults Posted
Study results publicly available
January 14, 2011
CompletedOctober 20, 2016
September 1, 2016
2 months
May 4, 2006
September 17, 2010
September 23, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (11)
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
The cut-off value for the rSBA-MenC titers was equal to or above 1:8. 0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section.
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
The cut-off value for the rSBA-MenC titers was equal to or above 1:32. 0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section.
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
The cut-off value for the rSBA-MenC titers was equal to or above 1:128. 0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section.
18, 30, 42, 54 and 66 months after booster dose (day 0)
rSBA-MenC Titers
Titers are expressed as Geometric Mean Titers (GMTs). 0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section.
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)
The cut-off value was an anti-PRP concentration equal to or above 0.15 µg/mL (microgram per milliliter).
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)
The cut-off value was an anti-PRP concentration equal to or above 1.0 µg/mL (microgram per milliliter).
18, 30, 42, 54 and 66 months after the booster dose (day 0)
Anti-PRP Concentrations
Concentrations are expressed as Geometric Mean Concentrations (GMCs) in µg/mL (microgram per milliliter).
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)
The cut-off value was an anti-PSC concentration equal to or above 0.3 µg/mL (microgram per milliliter). 0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section.
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)
The cut-off value was an anti-PSC concentration equal to or above 2.0 µg/mL (microgram per milliliter). 0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section.
18, 30, 42, 54 and 66 months after the booster dose (day 0)
Anti-PSC Concentrations
Concentrations for anti-PSC antibody were expressed as GMCs.
18, 30, 42, 54 and 66 months after the booster dose (day 0)
Number of Subjects With Serious Adverse Events
Serious adverse events assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
From last study contact of the booster study (NCT00323050) to Month 66 after booster dose (day 0)
Study Arms (3)
Menitorix/Pediarix Group
EXPERIMENTALSubjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
Infanrix hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group
ACTIVE COMPARATORSubjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
Infanrix hexa/Meningitec Group
ACTIVE COMPARATORSubjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
Interventions
Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age (group HibMenC) and as booster dose at 14 months of age (groups HibMenC and group NeisPoo).
Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age
Intramuscular injection into the thigh as primary vaccination at 2, 4 and/or 6 months of age (groups NeisPoo and MenCCRM) and/or as booster dose at 14 months of age (group MenCCRM).
Intramuscular injection into the thigh as a birth dose
Intramuscular injection into the thigh as primary vaccination at 2 and 4 months of age.
Intramuscular injection into the thigh as primary vaccination at 4 months of age
Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (12)
GSK Investigational Site
Almería, 04009, Spain
GSK Investigational Site
Burgos, 09005, Spain
GSK Investigational Site
Getafe/Madrid, 28905, Spain
GSK Investigational Site
Girona, 17002, Spain
GSK Investigational Site
Madrid, 28007, Spain
GSK Investigational Site
Madrid, 28041, Spain
GSK Investigational Site
Madrid, 28046, Spain
GSK Investigational Site
Marid, 28040, Spain
GSK Investigational Site
Málaga, 29011, Spain
GSK Investigational Site
Móstoles/Madrid, 28935, Spain
GSK Investigational Site
Valladolid, 47010, Spain
GSK Investigational Site
Vélez-Málaga / Málaga, 29700, Spain
Related Publications (4)
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.
PMID: 18536619BACKGROUNDTejedor 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.
PMID: 22828645BACKGROUNDTejedor 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.
BACKGROUNDTejedor 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.
BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2006
First Posted
May 5, 2006
Study Start
May 1, 2006
Primary Completion
July 1, 2006
Study Completion
September 1, 2010
Last Updated
October 20, 2016
Results First Posted
January 14, 2011
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.