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

GSK study ID
112830
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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:
Biological/vaccine: MenitorixTM
Biological/vaccine: Pneumococcal conjugate vaccine GSK1024850A
Biological/vaccine: PrevenarTM
Biological/vaccine: MeningitecTM
Biological/vaccine: NeisVac-CTM
Biological/vaccine: InfanrixTM hexa
Biological/vaccine: InfanrixTM penta
Biological/vaccine: InfanrixTM IPV/Hib
Biological/vaccine: InfanrixTM IPV
Enrollment:
582
Observational study model:
Not applicable
Primary completion date:
2012-21-11
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.

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Lobenstein, Thueringen, Germany, 07356
Status
Study Complete
Location
GSK Investigational Site
Weimar, Thueringen, Germany, 99425
Status
Study Complete
Location
GSK Investigational Site
Madrid, Spain, 28040
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
Location
GSK Investigational Site
Berlin, Berlin, Germany, 14197
Status
Study Complete
Location
GSK Investigational Site
Noerdlingen, Bayern, Germany, 86720
Status
Study Complete
Location
GSK Investigational Site
Debica, Poland, 39-200
Status
Study Complete
Location
GSK Investigational Site
Loehne, Nordrhein-Westfalen, Germany, 32584
Status
Study Complete
Location
GSK Investigational Site
Bretten, Baden-Wuerttemberg, Germany, 75015
Status
Study Complete
Location
GSK Investigational Site
Siemianowice Slaskie, Poland, 41-103
Status
Study Complete
Location
GSK Investigational Site
Karlsruhe, Baden-Wuerttemberg, Germany, 76189
Status
Study Complete
Location
GSK Investigational Site
Tettnang, Baden-Wuerttemberg, Germany, 88069
Status
Study Complete
Location
GSK Investigational Site
Doebeln, Sachsen, Germany, 04720
Status
Study Complete
Location
GSK Investigational Site
Móstoles/Madrid, Spain, 28935
Status
Study Complete
Location
GSK Investigational Site
Krakow, Poland
Status
Study Complete
Location
GSK Investigational Site
Hille, Nordrhein-Westfalen, Germany, 32479
Status
Study Complete
Location
GSK Investigational Site
Frankenthal, Rheinland-Pfalz, Germany, 67227
Status
Study Complete
Location
GSK Investigational Site
Muenchen, Bayern, Germany, 81735
Status
Study Complete
Location
GSK Investigational Site
Muenster, Nordrhein-Westfalen, Germany, 48163
Status
Study Complete
Location
GSK Investigational Site
Berlin, Berlin, Germany, 13355
Status
Study Complete
Location
GSK Investigational Site
Oberstenfeld, Baden-Wuerttemberg, Germany, 71720
Status
Study Complete
Location
GSK Investigational Site
Muenchen, Bayern, Germany, 81675
Status
Study Complete
Location
GSK Investigational Site
Schwaebisch-Hall, Baden-Wuerttemberg, Germany, 74523
Status
Study Complete
Location
GSK Investigational Site
Porta Westfalica, Nordrhein-Westfalen, Germany, 32457
Status
Study Complete
Location
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68163
Status
Study Complete
Location
GSK Investigational Site
Ettenheim, Baden-Wuerttemberg, Germany, 77955
Status
Study Complete

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
Completed
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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