Clinical trial NCT00891176: Persistence of Antibodies at 3, 4 and 6 Years of Age After Vaccination With Meningococcal, Pneumococcal and Hib Vaccines
Official title: Persistence of Antibodies After Full Vaccination Course With GSK Biologicals' Menitorix or MenC Conjugate Vaccine, Co-administered With DTPa or DTPa/Hib Containing Vaccine and Pneumococcal Conjugate Vaccine, in Children up to 6 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neisseria Meningitidis
Haemophilus Influenzae Type b
Keywords: Conjugate vaccines
Meningococcal serogroup C vaccine
Antibody persistence
Pneumococcal vaccine
Haemophilus Influenzae type b vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-05-01
Enrollment: 582
Sex: ALL
Minimum age (years): 36
Maximum age (years): 76
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This protocol posting deals with objectives \& outcome measures of an extension phase when subjects are aged 3, 4 and 6 years of age. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00334334). The objectives \& outcome measures of the booster phase are presented in a separate protocol posting (NCT number = NCT00463437).

The purpose of this study is to evaluate the persistence of pneumococcal, meningococcal serogroup C, Hib and Hepatits B antibodies after booster vaccination, when the subjects are aged 3, 4 and 6 years. No vaccine will be administered during this persistence phase of the study.

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 107005 and will not be further randomized in this study.

Eligibility criteria: Inclusion Criteria:

* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
* A male or female between, and including, 36 and 40 months of age at the time of Visit 1; between, and including, 48 and 52 months of age at the time of Visit 2; and between, and including, 72 and 76 months of age at the time of Visit 3.
* 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.
* Subjects who previously participated in the primary and booster studies, who received a full vaccination course with the vaccines corresponding to their group during the primary and booster studies and who were part, in the booster study, of the blood sampling subset.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the first blood sampling.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
* Administration of any additional meningococcal serogroup C, Hib, hepatitis B and pneumococcal vaccine since the end of the booster study
* History of meningococcal serogroup C, Haemophilus influenzae type b, hepatitis B and invasive pneumococcal diseases since the end of booster study.
* Any confirmed or suspected immunosuppressive or immunodeficient condition since the end of booster study, based on medical history and physical examination (no laboratory testing required).
* Administration of immunoglobulins and/or any blood products within the three months preceding the first blood sampling.

Primary outcomes:
measure: Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Titers Using Rabbit Complement (rSBA-MenC) Equal to or Above Cut-off Value
timeFrame: At 3 years of age
measure: Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Titers Using Rabbit Complement (rSBA-MenC) Equal to or Above Cut-off Value
timeFrame: At 6 years of age
measure: Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Titers Using Rabbit Complement (rSBA-MenC) Equal to or Above Cut-off Value
timeFrame: At 4 years of age
Secondary outcomes:
measure: Number of Subjects With an rSBA-MenC Titer Equal to or Above Cut-off Value
timeFrame: At 3 years of age
measure: rSBA-MenC Titers
timeFrame: At 3 years of age
measure: Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values
timeFrame: At 3 years of age
measure: Anti-PRP Concentrations
timeFrame: At 3 years of age
measure: Antibody Concentrations Against Vaccine Pneumococcal Serotypes
timeFrame: At 3 years of age
measure: Number of Subjects With Opsonophagocytic Activity
timeFrame: At 3 years of age
measure: Concentration of Antibodies Against Protein D
timeFrame: At 3 years of age
measure: Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values
timeFrame: At 3 years of age
measure: Anti-HBs Antibody Concentrations
timeFrame: At 3 years of age
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: From last study contact of the study (NCT00463437) at 17-24 months of age until 3 years of age
measure: rSBA-MenC Titers
timeFrame: At 4 years of age
measure: Number of Subjects With an rSBA-MenC Titer Equal to or Above Cut-off Value
timeFrame: At 4 years of age
measure: Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values
timeFrame: At 4 years of age
measure: Anti-PRP Concentrations
timeFrame: At 4 years of age
measure: Antibody Concentrations Against Vaccine Pneumococcal Serotypes
timeFrame: At 4 years of age
measure: Number of Subjects With Opsonophagocytic Activity
timeFrame: At 4 years of age
measure: Concentration of Antibodies Against Protein D
timeFrame: At 4 years of age
measure: Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values
timeFrame: At 4 years of age
measure: Anti-HBs Antibody Concentrations
timeFrame: At 4 years of age
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: From last study contact of the study (NCT00463437) at 17-24 months of age until 4 years of age
measure: Number of Subjects With rSBA-MenC Titer Equal to or Above Cut-off Value
timeFrame: At 6 years of age
measure: rSBA-MenC Titers
timeFrame: At 6 years of age
measure: Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values
timeFrame: At 6 years of age
measure: Anti-PRP Concentrations
timeFrame: At 6 years of age
measure: Antibody Concentrations Against Vaccine Pneumococcal Serotypes
timeFrame: At 6 years of age
measure: Concentration of Antibodies Against Protein D
timeFrame: At 6 years of age
measure: Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values as Measured by ELISA.
timeFrame: At 3 and 4 years of age
measure: Anti-HBs Antibody Concentrations as Measured by ELISA
timeFrame: At 3 and 4 years of age
measure: Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values
timeFrame: At 3, 4 and 6 years of age
measure: Anti-HBs Antibody Concentrations
timeFrame: At 3, 4 and 6 years of age
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: From last study contact of the study (NCT00463437) at 17-24 months of age until 6 years of age
Other outcomes:
Locations:
city: Bad Saulgau
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Bretten
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Ettenheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Karlsruhe
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Kehl
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Mannheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Oberstenfeld
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Schwaebisch-Hall
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Tettnang
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Noerdlingen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Hille
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Loehne
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Muenster
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Porta Westfalica
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Frankenthal
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Trier
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Doebeln
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Lobenstein
country: Germany
facility: GSK Investigational Site
state: Thueringen
city: Weimar
country: Germany
facility: GSK Investigational Site
state: Thueringen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Debica
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Siemianowice Slaskie
country: Poland
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Móstoles/Madrid
country: Spain
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Tejedor JC, Brzostek J, Konior R, Grunert D, Kolhe D, Baine Y, Van Der Wielen M. Antibody Persistence in Young Children 5 Years after Vaccination with a Combined Haemophilus influenzae Type b-Neisseria meningitidis Serogroup C Conjugate Vaccine Coadministered with Diphtheria-Tetanus-Acellular Pertussis-Based and Pneumococcal Conjugate Vaccines. Clin Vaccine Immunol. 2016 Jul 5;23(7):555-63. doi: 10.1128/CVI.00057-16. Print 2016 Jul.