Last updated: 11/07/2018 05:16:29
Persistence of antibodies at 3, 4 and 6 years of age after vaccination with meningococcal, pneumococcal and Hib vaccines
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
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
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
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:
Number of subjects with an rSBA-MenC titer equal to or above cut-off value
Timeframe: At 3 years of age
rSBA-MenC titers
Timeframe: At 3 years of age
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
Anti-PRP concentrations
Timeframe: At 3 years of age
Antibody concentrations against vaccine pneumococcal serotypes
Timeframe: At 3 years of age
Number of subjects with opsonophagocytic activity
Timeframe: At 3 years of age
Concentration of antibodies against protein D
Timeframe: At 3 years of age
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
Anti-HBs antibody concentrations
Timeframe: At 3 years of age
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
rSBA-MenC titers
Timeframe: At 4 years of age
Number of subjects with an rSBA-MenC titer equal to or above cut-off value
Timeframe: At 4 years of age
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
Anti-PRP concentrations
Timeframe: At 4 years of age
Antibody concentrations against vaccine pneumococcal serotypes
Timeframe: At 4 years of age
Number of subjects with opsonophagocytic activity
Timeframe: At 4 years of age
Concentration of antibodies against protein D
Timeframe: At 4 years of age
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
Anti-HBs antibody concentrations
Timeframe: At 4 years of age
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
Number of subjects with rSBA-MenC titer equal to or above cut-off value
Timeframe: At 6 years of age
rSBA-MenC titers
Timeframe: At 6 years of age
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
Anti-PRP concentrations
Timeframe: At 6 years of age
Antibody concentrations against vaccine pneumococcal serotypes
Timeframe: At 6 years of age
Concentration of antibodies against protein D
Timeframe: At 6 years of age
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
Anti-HBs antibody concentrations as measured by ELISA
Timeframe: At 3 and 4 years of age
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
Anti-HBs antibody concentrations
Timeframe: At 3, 4 and 6 years of age
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
Interventions:
Enrollment:
582
Primary completion date:
2012-21-11
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Tejedor JC et al. (2016) 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. 23(7):555-563. doi: 10.1128/CVI.00057-16.
Medical condition
Neisseria Meningitidis, Haemophilus influenzae type b
Product
GSK1024850A, GSK2105254A, SB213503, SB217744, SB811936
Collaborators
Not applicable
Study date(s)
May 2009 to November 2012
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
36 - 76 months
Accepts healthy volunteers
Yes
- 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.
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
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.
Exclusion criteria:
- 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.
Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the first blood sampling.
Trial location(s)
Location
GSK Investigational Site
Lobenstein, Thueringen, Germany, 07356
Status
Study Complete
Location
GSK Investigational Site
Kehl, Baden-Wuerttemberg, Germany, 77694
Status
Study Complete
Location
GSK Investigational Site
Bad Saulgau, Baden-Wuerttemberg, Germany, 88348
Status
Study Complete
Location
GSK Investigational Site
Trier, Rheinland-Pfalz, Germany, 54290
Status
Study Complete
Showing 1 - 6 of 28 Results
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
Study complete
Actual primary completion date
2012-21-11
Actual study completion date
2012-21-11
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.
Additional information about the trial
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