Long-term Persistence Study to Assess a Booster Dose of GSK Biologicals' Hib-MenC - Full Text View

Purpose

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.

Condition	Intervention	Phase
Haemophilus Influenzae Type b Disease Meningococcal Serogroup C Diseases	Biological: Haemophilus influenzae type b- and meningococcal (vaccine) Biological: Infanrix™ penta Biological: Infanrix™ hexa Biological: Engerix-B Biological: NeisVac-C™ Biological: Infanrix™ IPV/HIB Biological: Meningitec™	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
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

Resource links provided by NLM:

MedlinePlus related topics: Flu

Drug Information available for: Boostrix Adacel

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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 [ Time Frame: 18, 30, 42, 54 and 66 months after booster dose (day 0) ] [ Designated as safety issue: No ]
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.
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 [ Time Frame: 18, 30, 42, 54 and 66 months after booster dose (day 0) ] [ Designated as safety issue: No ]
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.
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 [ Time Frame: 18, 30, 42, 54 and 66 months after booster dose (day 0) ] [ Designated as safety issue: No ]
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.
rSBA-MenC Titers [ Time Frame: 18, 30, 42, 54 and 66 months after booster dose (day 0) ] [ Designated as safety issue: No ]
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.
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) [ Time Frame: 18, 30, 42, 54 and 66 months after the booster dose (day 0) ] [ Designated as safety issue: No ]
The cut-off value was an anti-PRP concentration equal to or above 0.15 µg/mL (microgram per milliliter).
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) [ Time Frame: 18, 30, 42, 54 and 66 months after the booster dose (day 0) ] [ Designated as safety issue: No ]
The cut-off value was an anti-PRP concentration equal to or above 1.0 µg/mL (microgram per milliliter).
Anti-PRP Concentrations [ Time Frame: 18, 30, 42, 54 and 66 months after the booster dose (day 0) ] [ Designated as safety issue: No ]
Concentrations are expressed as Geometric Mean Concentrations (GMCs) in µg/mL (microgram per milliliter).
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) [ Time Frame: 18, 30, 42, 54 and 66 months after the booster dose (day 0) ] [ Designated as safety issue: No ]
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.
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) [ Time Frame: 18, 30, 42, 54 and 66 months after the booster dose (day 0) ] [ Designated as safety issue: No ]
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.
Anti-PSC Concentrations [ Time Frame: 18, 30, 42, 54 and 66 months after the booster dose (day 0) ] [ Designated as safety issue: No ]
Concentrations for anti-PSC antibody were expressed as GMCs.
Number of Subjects With Serious Adverse Events [ Time Frame: From last study contact of the booster study (NCT00323050) to Month 66 after booster dose (day 0) ] [ Designated as safety issue: No ]
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.

Enrollment:	230
Study Start Date:	May 2006
Study Completion Date:	September 2010
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Menitorix/Pediarix Group Subjects 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.	Biological: Haemophilus influenzae type b- and meningococcal (vaccine) 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). Biological: Infanrix™ penta Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age
Active Comparator: Infanrix hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group Subjects 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.	Biological: Haemophilus influenzae type b- and meningococcal (vaccine) 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). Biological: Infanrix™ hexa 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). Biological: Engerix-B Intramuscular injection into the thigh as a birth dose Biological: NeisVac-C™ Intramuscular injection into the thigh as primary vaccination at 2 and 4 months of age. Biological: Infanrix™ IPV/HIB Intramuscular injection into the thigh as primary vaccination at 4 months of age
Active Comparator: Infanrix hexa/Meningitec Group Subjects 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.	Biological: Infanrix™ hexa 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). Biological: Meningitec™ Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age

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

Ages Eligible for Study:	31 Months to 33 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00322335

Locations

Spain
GSK Investigational Site
Almería, Spain, 04009
GSK Investigational Site
Burgos, Spain, 09005
GSK Investigational Site
Gerona, Spain, 17002
GSK Investigational Site
Getafe/Madrid, Spain, 28905
GSK Investigational Site
Madrid, Spain, 28041
GSK Investigational Site
Madrid, Spain, 28046
GSK Investigational Site
Madrid, Spain, 28007
GSK Investigational Site
Marid, Spain, 28040
GSK Investigational Site
Málaga, Spain, 29011
GSK Investigational Site
Móstoles/Madrid, Spain, 28935
GSK Investigational Site
Valladolid, Spain, 47010
GSK Investigational Site
Vélez-Málaga / Málaga, Spain, 29700

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Publications:

Tejedor JC, Moro M, Merino JM, Gómez-Campderá JA, García-del-Rio M, Jurado A, Díez-Delgado FJ, Omeñaca F, García-Sicilia J, Ruiz-Contreras J, Martin-Ancel A, Roca J, Boceta R, García-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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Tejedor JC, Merino JM, Moro M, Navarro ML, Espín J, Omeñaca F, García-Sicilia J, Moreno-Pérez 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.

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00322335 History of Changes
Other Study ID Numbers:	106672, 106673, 106675, 106679, 106680
Study First Received:	May 4, 2006
Results First Received:	September 17, 2010
Last Updated:	November 10, 2011
Health Authority:	Spain: agencia española del medicamento

Keywords provided by GlaxoSmithKline:

H.influenzae type b Disease

Additional relevant MeSH terms:

Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections

Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013