Neisseria MeningitidisPhase 3NCT00891176
Persistence of Antibodies at 3, 4 and 6 Years of Age After Vaccination With Meningococcal, Pneumococcal and Hib Vaccines
A Phase 3 study testing MenitorixTM, Pneumococcal conjugate vaccine GSK1024850A and PrevenarTM in people with Neisseria Meningitidis and Haemophilus Influenzae Type b, run by GlaxoSmithKline at 28 sites in 3 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 36 to 76 monthsHealthy volunteers can take part
- Conditions the study is for
- Neisseria Meningitidis, Haemophilus Influenzae Type b
- What is being tested?
- MenitorixTM, Pneumococcal conjugate vaccine GSK1024850A and PrevenarTM
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 582 participants
- Where
- 28 sitesin 3 countries
- Study dates
- 14 May 2009to 21 Nov 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 36 to 76 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
28 sites in 3 countries.
28 sites in 3 countries
Germany23 sites
GSK Investigational Site
Bad Lobenstein, Thuringia, 07356
GSK Investigational Site
Bad Saulgau, Baden-Wurttemberg, 88348
GSK Investigational Site
Berlin, 13355
GSK Investigational Site
Berlin, 14197
GSK Investigational Site
Bretten, Baden-Wurttemberg, 75015
GSK Investigational Site
Döbeln, Saxony, 04720
GSK Investigational Site
Ettenheim, Baden-Wurttemberg, 77955
GSK Investigational Site
Frankenthal, Rhineland-Palatinate, 67227
GSK Investigational Site
Hille, North Rhine-Westphalia, 32479
GSK Investigational Site
Karlsruhe, Baden-Wurttemberg, 76189
GSK Investigational Site
Kehl, Baden-Wurttemberg, 77694
GSK Investigational Site
Löhne, North Rhine-Westphalia, 32584
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68163
GSK Investigational Site
Munich, Bavaria, 81675
GSK Investigational Site
Munich, Bavaria, 81735
GSK Investigational Site
Münster, North Rhine-Westphalia, 48163
GSK Investigational Site
Nördlingen, Bavaria, 86720
GSK Investigational Site
Oberstenfeld, Baden-Wurttemberg, 71720
GSK Investigational Site
Porta Westfalica, North Rhine-Westphalia, 32457
GSK Investigational Site
Schwäbisch Hall, Baden-Wurttemberg, 74523
GSK Investigational Site
Tettnang, Baden-Wurttemberg, 88069
GSK Investigational Site
Trier, Rhineland-Palatinate, 54290
GSK Investigational Site
Weimar, Thuringia, 99425
Poland3 sites
GSK Investigational Site
Dębica, 39-200
GSK Investigational Site
Krakow
GSK Investigational Site
Siemianowice Śląskie, 41-103
Spain2 sites
GSK Investigational Site
Madrid, 28040
GSK Investigational Site
Móstoles/Madrid, 28935
About this study
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
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.
Read the 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.
- Being tested
- MenitorixTM, Pneumococcal conjugate vaccine GSK1024850A, PrevenarTM, MeningitecTM, NeisVac-CTM
- Keywords
- Conjugate vaccines, Meningococcal serogroup C vaccine, Antibody persistence, Pneumococcal vaccine, Haemophilus Influenzae type b vaccine
- Medical subject headings
- Haemophilus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MenitorixTMBiological
Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study.
Pneumococcal conjugate vaccine GSK1024850ABiological
Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study.
PrevenarTMBiological
Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study.
MeningitecTMBiological
Intramuscular injection into the thigh as primary vaccination at 2 and 4 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study
NeisVac-CTMBiological
Intramuscular injection into the thigh as primary vaccination at 2 and 4 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study
InfanrixTM hexaBiological
Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age (all countries) and as booster dose at 11-18 months of age (Germany and Poland). No vaccine was administered during this long-term follow up study
InfanrixTM pentaBiological
Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age (all countries) and as booster dose at 11-18 months of age (Germany and Poland). No vaccine was administered during this long-term follow up study
InfanrixTM IPV/HibBiological
Intramuscular injection into the thigh as booster dose at 11-18 months of age (Spain). No vaccine was administered during this long-term follow up study
InfanrixTM IPVBiological
Intramuscular injection into the thigh as booster dose at 11-18 months of age (Spain). No vaccine was administered during this long-term follow up study
| Study group | Role | What they receive |
|---|---|---|
| Synflorix-Meningitec Group | Experimental | Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age. 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa. Receives: Biological: Pneumococcal conjugate vaccine GSK1024850A; Biological: MeningitecTM; Biological: InfanrixTM hexa; Biological: InfanrixTM IPV/Hib |
| Synflorix-NeisVac-C Group | Experimental | Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa. Receives: Biological: Pneumococcal conjugate vaccine GSK1024850A; Biological: NeisVac-CTM; Biological: InfanrixTM hexa; Biological: InfanrixTM IPV/Hib |
| Synflorix-Menitorix Group | Experimental | Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta. Receives: Biological: MenitorixTM; Biological: Pneumococcal conjugate vaccine GSK1024850A; Biological: InfanrixTM penta; Biological: InfanrixTM IPV |
| Prevenar-Menitorix Group | Active comparator | Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta. Receives: Biological: MenitorixTM; Biological: Pneumococcal conjugate vaccine GSK1024850A; Biological: PrevenarTM; Biological: InfanrixTM penta; Biological: InfanrixTM IPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Titers Using Rabbit Complement (rSBA-MenC) Equal to or Above Cut-off Value
rSBA-MenC antibody cut-off value assessed was equal to or above 1:8. The rSBA-MenC assay was performed at the Public Health England (PHE) laboratory at 6 years of age while the GSK laboratory was used for testing at 3 and 4 years of age.
Measured: 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
rSBA-MenC antibody cut-off value assessed was equal to or above 1:8. The rSBA-MenC assay was performed at the Public Health England (PHE) laboratory at 6 years of age while the GSK laboratory was used for testing at 3 and 4 years of age.
Measured: 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
rSBA-MenC antibody cut-off value assessed was equal to or above 1:8. The rSBA-MenC assay was performed at the Public Health England (PHE) laboratory at 6 years of age while the GSK laboratory was used for testing at 3 and 4 years of age.
Measured: At 4 years of age
Secondary outcomes (31)
Number of Subjects With an rSBA-MenC Titer Equal to or Above Cut-off Value
The cut-off value was defined as a titer equal to or above 1:128.
Measured: At 3 years of age
rSBA-MenC Titers
Titers are given as Geometric Mean Titers (GMTs).
Measured: At 3 years of age
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values
The cut-off values were defined as a concentration equal to or above 0.15 microgram per milliliter (μg/mL) and equal to or above 1.0 μg/mL.
Measured: At 3 years of age
Anti-PRP Concentrations
Concentrations were defined as Geometric Mean Concentrations (GMCs) in μg/mL,
Measured: At 3 years of age
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Antibody concentrations were expressed as GMCs in μg/mL.
Vaccine pneumococcal serotypes assessed included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Measured: At 3 years of age
Number of Subjects With Opsonophagocytic Activity
Opsonophagocytic activity was measured by a killing-assay. The results were presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay was an opsonic titre of 8.
Measured: At 3 years of age
Concentration of Antibodies Against Protein D
Concentrations were expressed as GMCs in enzyme-linked immunosorbent-assay (ELISA) units per milliliter (EL.U/mL).
Measured: 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
Cut-off values assessed were defined as equal to or above 10 milli-international units per milliliter (mIU/mL) or equal to or above 100 mIU/mL.
Measured: At 3 years of age
Anti-HBs Antibody Concentrations
Concentrations were expressed as GMCs in mIU/mL.
Measured: At 3 years of age
Number of Subjects With Serious Adverse Events (SAEs)
SAEs 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. Related = SAE assessed by the investigator as being related to the study procedures.
Measured: From last study contact of the study (NCT00463437) at 17-24 months of age until 3 years of age
rSBA-MenC Titers
Titers are given as Geometric Mean Titers (GMTs).
Measured: At 4 years of age
Number of Subjects With an rSBA-MenC Titer Equal to or Above Cut-off Value
rSBA-MenC antibody cut-off value assessed was equal to or above 1:128.
Measured: At 4 years of age
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values
The cut-off values were defined as a concentration equal to or above 0.15 microgram per milliliter (μg/mL) and equal to or above 1.0 μg/mL.
Measured: At 4 years of age
Anti-PRP Concentrations
Concentrations were defined as Geometric Mean Concentrations (GMCs) in μg/mL
Measured: At 4 years of age
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Antibody concentrations were expressed as GMCs in μg/mL. Vaccine pneumococcal serotypes assessed included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Measured: At 4 years of age
Number of Subjects With Opsonophagocytic Activity
Opsonophagocytic activity was measured by a killing-assay. The results were presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay was an opsonic titer of 8.
Measured: At 4 years of age
Concentration of Antibodies Against Protein D
Concentrations were expressed as GMCs in enzyme-linked immunosorbent-assay (ELISA) units per milliliter (EL.U/mL).
Measured: 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
Cut-off values assessed were defined as equal to or above 10 milli-international units per milliliter (mIU/mL) or equal to or above 100 mIU/mL.
Measured: At 4 years of age
Anti-HBs Antibody Concentrations
Concentrations were expressed as GMCs in mIU/mL.
Measured: At 4 years of age
Number of Subjects With Serious Adverse Events (SAEs)
SAEs 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. Related = SAE assessed by the investigator as being related to the study procedures.
Measured: 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
rSBA-MenC antibody cut-off value assessed was equal to or above 1:128.
Measured: At 6 years of age
rSBA-MenC Titers
Titers are given as Geometric Mean Titers (GMTs).
Measured: At 6 years of age
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values
The cut-off values were defined as a concentration ≥ 0.15 microgram per milliliter (μg/mL) and ≥ 1.0 μg/mL.
Measured: At 6 years of age
Anti-PRP Concentrations
Concentrations were defined as Geometric Mean Concentrations (GMCs) in μg/mL
Measured: At 6 years of age
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Antibody concentrations were expressed as GMCs in μg/mL. Vaccine pneumococcal serotypes assessed included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Measured: At 6 years of age
Concentration of Antibodies Against Protein D
Concentrations were expressed as GMCs in enzyme-linked immunosorbent-assay (ELISA) units per milliliter (EL.U/mL).
Measured: 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.
Cut-off values assessed were defined as equal to or above 10 milli-international units per milliliter (mIU/mL) or equal to or above 100 mIU/mL.
Measured: At 3 and 4 years of age
Anti-HBs Antibody Concentrations as Measured by ELISA
Concentrations were expressed as GMCs in mIU/mL.
Measured: 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
Cut-off values assessed were defined as equal to or above (≥) 6.2 milli-international units per milliliter (mIU/mL), 10 mIU/mL and 100 mIU/mL.
Note: A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL) when tested by Enzyme-Linked Immunosorbent Assay (ELISA). The tables show both the results obtained by ELISA as well as updated results following complete retesting and reanalysis by a Chemiluminescence immunoassay (CLIA). Anti-HBs seroprotection was redefined as CLIA concentration above 10 mIU/mL.
Measured: At 3, 4 and 6 years of age
Anti-HBs Antibody Concentrations
Concentrations were expressed as GMCs in mIU/mL. Note: A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL) when tested by ELISA. The tables show both the results obtained by ELISA as well as updated results following complete retesting and reanalysis by a Chemiluminescence immunoassay (CLIA).
Measured: At 3, 4 and 6 years of age
Number of Subjects With Serious Adverse Events (SAEs)
SAEs 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. Related = SAE assessed by the investigator as being related to the study procedures.
Measured: From last study contact of the study (NCT00463437) at 17-24 months of age until 6 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2009 (estimated)
- Study start14 May 2009
- Primary completion21 Nov 2012
- Study completion21 Nov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neisseria MeningitidisStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 582 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00891176
- Sponsor's protocol ID
- 112830
- Status last verified
- Sep 2016
- First submitted
- 30 Apr 2009
- Last updated
- 15 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
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.
PubMed 27145999
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00891176
- Acronym / sponsor ID
- 112830
- Keywords
- Conjugate vaccines, Meningococcal serogroup C vaccine, Antibody persistence, Pneumococcal vaccine, Haemophilus Influenzae type b vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 582 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 14 May 2009
- Primary completion
- 21 Nov 2012 (actual)
- Study completion
- 21 Nov 2012 (actual)
- First posted
- 1 May 2009 (estimated)
- Results
- Posted 23 Dec 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Synflorix-Meningitec Group | Experimental | Biological: Pneumococcal conjugate vaccine GSK1024850A, Biological: MeningitecTM, Biological: InfanrixTM hexa, Biological: InfanrixTM IPV/HibSubjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age. 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa. |
| Synflorix-NeisVac-C Group | Experimental | Biological: Pneumococcal conjugate vaccine GSK1024850A, Biological: NeisVac-CTM, Biological: InfanrixTM hexa, Biological: InfanrixTM IPV/HibSubjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa. |
| Synflorix-Menitorix Group | Experimental | Biological: MenitorixTM, Biological: Pneumococcal conjugate vaccine GSK1024850A, Biological: InfanrixTM penta, Biological: InfanrixTM IPVSubjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta. |
| Prevenar-Menitorix Group | Active comparator | Biological: MenitorixTM, Biological: Pneumococcal conjugate vaccine GSK1024850A, Biological: PrevenarTM, Biological: InfanrixTM penta, Biological: InfanrixTM IPVSubjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta. |
Who may qualify
- Ages
- 36 to 76 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MenitorixTMIntramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study. | Biological | Prevenar-Menitorix Group, Synflorix-Menitorix Group |
| Pneumococcal conjugate vaccine GSK1024850AIntramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study. | Biological | Prevenar-Menitorix Group, Synflorix-Meningitec Group, Synflorix-Menitorix Group, Synflorix-NeisVac-C Group |
| PrevenarTMIntramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study. | Biological | Prevenar-Menitorix Group |
| MeningitecTMIntramuscular injection into the thigh as primary vaccination at 2 and 4 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study | Biological | Synflorix-Meningitec Group |
| NeisVac-CTMIntramuscular injection into the thigh as primary vaccination at 2 and 4 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study | Biological | Synflorix-NeisVac-C Group |
| InfanrixTM hexaIntramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age (all countries) and as booster dose at 11-18 months of age (Germany and Poland). No vaccine was administered during this long-term follow up study | Biological | Synflorix-Meningitec Group, Synflorix-NeisVac-C Group |
| InfanrixTM pentaIntramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age (all countries) and as booster dose at 11-18 months of age (Germany and Poland). No vaccine was administered during this long-term follow up study | Biological | Prevenar-Menitorix Group, Synflorix-Menitorix Group |
| InfanrixTM IPV/HibIntramuscular injection into the thigh as booster dose at 11-18 months of age (Spain). No vaccine was administered during this long-term follow up study | Biological | Synflorix-Meningitec Group, Synflorix-NeisVac-C Group |
| InfanrixTM IPVIntramuscular injection into the thigh as booster dose at 11-18 months of age (Spain). No vaccine was administered during this long-term follow up study | Biological | Prevenar-Menitorix Group, Synflorix-Menitorix Group |
Primary outcome
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Titers Using Rabbit Complement (rSBA-MenC) Equal to or Above Cut-off Value
Time frame: At 3 years of age
rSBA-MenC antibody cut-off value assessed was equal to or above 1:8. The rSBA-MenC assay was performed at the Public Health England (PHE) laboratory at 6 years of age while the GSK laboratory was used for testing at 3 and 4 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
Time frame: At 6 years of age
rSBA-MenC antibody cut-off value assessed was equal to or above 1:8. The rSBA-MenC assay was performed at the Public Health England (PHE) laboratory at 6 years of age while the GSK laboratory was used for testing at 3 and 4 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
Time frame: At 4 years of age
rSBA-MenC antibody cut-off value assessed was equal to or above 1:8. The rSBA-MenC assay was performed at the Public Health England (PHE) laboratory at 6 years of age while the GSK laboratory was used for testing at 3 and 4 years of age.
31 secondary outcomes
Number of Subjects With an rSBA-MenC Titer Equal to or Above Cut-off Value
Time frame: At 3 years of age
rSBA-MenC Titers
Time frame: At 3 years of age
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values
Time frame: At 3 years of age
Anti-PRP Concentrations
Time frame: At 3 years of age
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Time frame: At 3 years of age
Number of Subjects With Opsonophagocytic Activity
Time frame: At 3 years of age
Concentration of Antibodies Against Protein D
Time frame: 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
Time frame: At 3 years of age
Anti-HBs Antibody Concentrations
Time frame: At 3 years of age
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: From last study contact of the study (NCT00463437) at 17-24 months of age until 3 years of age
rSBA-MenC Titers
Time frame: At 4 years of age
Number of Subjects With an rSBA-MenC Titer Equal to or Above Cut-off Value
Time frame: At 4 years of age
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values
Time frame: At 4 years of age
Anti-PRP Concentrations
Time frame: At 4 years of age
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Time frame: At 4 years of age
Number of Subjects With Opsonophagocytic Activity
Time frame: At 4 years of age
Concentration of Antibodies Against Protein D
Time frame: 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
Time frame: At 4 years of age
Anti-HBs Antibody Concentrations
Time frame: At 4 years of age
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: 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
Time frame: At 6 years of age
rSBA-MenC Titers
Time frame: At 6 years of age
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values
Time frame: At 6 years of age
Anti-PRP Concentrations
Time frame: At 6 years of age
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Time frame: At 6 years of age
Concentration of Antibodies Against Protein D
Time frame: 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.
Time frame: At 3 and 4 years of age
Anti-HBs Antibody Concentrations as Measured by ELISA
Time frame: 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
Time frame: At 3, 4 and 6 years of age
Anti-HBs Antibody Concentrations
Time frame: At 3, 4 and 6 years of age
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: From last study contact of the study (NCT00463437) at 17-24 months of age until 6 years of age
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27145999Tejedor 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.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
28 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MenitorixTM, Pneumococcal conjugate vaccine GSK1024850A and PrevenarTM in people with Neisseria Meningitidis and Haemophilus Influenzae Type b, run by GlaxoSmithKline at 28 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Germany, Poland, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Dec 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Titers Using Rabbit Complement (rSBA-MenC) Equal to or Above Cut-off Value (time frame: At 3 years of age). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00891176, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2018.