TetanusPhase 2NCT01090453
Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants
A Phase 2 study testing GSK2202083A vaccine, Prevenar 13® and Infanrix hexa™ in people with Tetanus and Hepatitis B, run by GlaxoSmithKline at 34 sites in 3 countries.
Trial summary
This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083 vaccine co-administered with Prevenar 13® at 2, 4 and 12 months of age and with Rotarix™ at 2 and 4 months of age. Read more about this study
- Who is it for?
- Ages 8 to 12 weeksHealthy volunteers can take part
- Conditions the study is for
- Tetanus, Hepatitis B, Haemophilus Influenzae Type b
- What is being tested?
- GSK2202083A vaccine, Prevenar 13® and Infanrix hexa™
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 34 sitesin 3 countries
- Study dates
- 17 May 2010to 11 Oct 2011
- Phase
- Phase 2
- 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 8 to 12 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
- A male or female infant between, and including, 8 and 12 weeks at the time of the first vaccination.
- Born after a gestation period of 36 to 42 weeks inclusive.
- Written informed consent obtained from the parent(s), Legally Acceptable Representative(s) of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Who cannot join
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- Child in care.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Administration of a vaccine not foreseen by the study protocol within 30 days prior to randomisation, or planned administration from randomisation to the end of the study with the exception of inactivated influenza vaccines. The administration of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae type b, pneumococcal, rotavirus and/or MenC vaccines is not allowed at any time during the study period but other vaccines are allowed during the period from one day after study Visit 3 to 31 days before study Visit 4.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
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- Evidence of previous diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Hib, pneumococcal, rotavirus and/or MenC vaccination or disease, including Hepatitis B virus vaccination at birth.
- History of seizures or progressive neurological disease.
- Subjects with history of intussusception or uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
- Major congenital defects or serious chronic illness.
- The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met:
- Current febrile illness or other moderate to severe illness within 24 hours of study vaccine administration.
- Current gastrointestinal infection.
Trial locations and contacts
34 sites in 3 countries.
34 sites in 3 countries
Germany22 sites
GSK Investigational Site
Bad Saulgau, Baden-Wurttemberg, 88348
GSK Investigational Site
Berchtesgaden, Bavaria, 83471
GSK Investigational Site
Bindlach, Bavaria, 95463
GSK Investigational Site
Detmold, North Rhine-Westphalia, 32756
GSK Investigational Site
Eschwege, Hesse, 37269
GSK Investigational Site
Frankenthal, Rhineland-Palatinate, 67227
GSK Investigational Site
Heiligenhaus, North Rhine-Westphalia, 42579
GSK Investigational Site
Kehl, Baden-Wurttemberg, 77694
GSK Investigational Site
Kleve-Materborn, North Rhine-Westphalia, 47533
GSK Investigational Site
Löhne, North Rhine-Westphalia, 32584
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55131
GSK Investigational Site
Munich, Bavaria, 81735
GSK Investigational Site
Nördlingen, Bavaria, 86720
GSK Investigational Site
Porta Westfalica, North Rhine-Westphalia, 32457
GSK Investigational Site
Schwäbisch Hall, Baden-Wurttemberg, 74523
GSK Investigational Site
Solingen, North Rhine-Westphalia, 42719
GSK Investigational Site
Stuttgart, Baden-Wurttemberg, 70469
GSK Investigational Site
Trier, Rhineland-Palatinate, 54290
GSK Investigational Site
Tuttlingen, Baden-Wurttemberg, 78532
GSK Investigational Site
Willich, North Rhine-Westphalia, 47877
GSK Investigational Site
Wolfenbüttel, Lower Saxony, 38302
GSK Investigational Site
Worms, Rhineland-Palatinate, 67547
France9 sites
GSK Investigational Site
Aix-en-Provence, 13100
GSK Investigational Site
Dax, 40100
GSK Investigational Site
Draguignan, 83300
GSK Investigational Site
Essey-lès-Nancy, 54270
GSK Investigational Site
Floirac, 33270
GSK Investigational Site
Le Havre, 76600
GSK Investigational Site
Lingolsheim, 67380
GSK Investigational Site
Nice, 06300
GSK Investigational Site
Trélazé, 49800
Canada3 sites
GSK Investigational Site
Hamilton, Ontario, L8L 5G8
GSK Investigational Site
Vancouver, British Columbia, V5Z 4H4
GSK Investigational Site
Winnipeg, Manitoba, R3E 3P4
About this study
Official title: Feasibility Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 4 and 12 Months of Age
This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083 vaccine co-administered with Prevenar 13® at 2, 4 and 12 months of age and with Rotarix™ at 2 and 4 months of age.
- Conditions
- Tetanus, Hepatitis B, Haemophilus Influenzae Type b, Poliomyelitis, Acellular Pertussis, Diphtheria
- Being tested
- GSK2202083A vaccine, Prevenar 13®, Infanrix hexa™, Menjugate®, Rotarix™
- Medical subject headings
- Tetanus, Hepatitis B, Haemophilus Infections, Poliomyelitis, Diphtheria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK2202083A vaccineBiological
3 doses given at 2, 4 and 12 months of age
Prevenar 13®Biological
3 co-administered doses
Infanrix hexa™Biological
3 doses given at 2, 4 and 12 months of age
Menjugate®Biological
3 co-administered doses
Rotarix™Biological
Oral, two doses
| Study group | Role | What they receive |
|---|---|---|
| GSK2202083A Group | Experimental | Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age. Receives: Biological: GSK2202083A vaccine; Biological: Prevenar 13®; Biological: Rotarix™ |
| Infanrix hexa Group | Active comparator | Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age. Receives: Biological: Prevenar 13®; Biological: Infanrix hexa™; Biological: Menjugate®; Biological: Rotarix™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Above the Cut-off
The anti-PRP antibody concentration cut-off for this assay was greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL).
Measured: At Month 3
Number of Subjects With Neisseria Meningitidis Using Baby Rabbit Complement (rSBA-MenC) Antibody Titers Above the Cut-off
The rSBA-MenC antibody titers cut-off for this assay was ≥ 1:8.
Measured: At Month 3
Secondary outcomes (20)
Number of Subjects With Anti-PRP Antibody Concentrations Above the Cut-offs
The anti-PRP antibody concentration cut-offs for this assay were ≥ 0.15 µg/mL and 1.0 µg/mL. Values concerning the cut-off of 0.15 µg/mL at Month 3 were listed for a primary outcome, hence they were not reported under this outcome.
Measured: At Month 3, Month 10 and Month 11.
Number of Subjects With rSBA-MenC Antibody Titers Above the Cut-offs
The rSBA-MenC antibody titers cut-off for this assay were ≥ 1:8 and ≥ 1:128. Values concerning the cut-off of 1:8 at Month 3 were listed for a primary outcome, hence they were not reported under this outcome.
Measured: At Month 3, Month 10 and Month 11.
Concentrations for Anti-PRP.
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off values were ≥ 0.15 µg/mL and ≥ 1.0 µg/mL.
Measured: At Month 3, Month 10 and Month 11.
Titers for rSBA-MenC.
Titers were expressed as geometric mean titers (GMCs). The seropositivity reference cut-off values were ≥ 1:8 and ≥ 1:128.
Measured: At Month 3, Month 10 and Month 11.
Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies Above the Cut-off.
The anti-D and anti-T antibody cut-off was ≥ 0.1 international units per milliliter (IU/mL).
Measured: At Month 3, Month 10 and Month 11.
Concentrations for Anti-T and Anti-D.
Concentrations were expressed as geometric mean concentrations (GMCs). The reference cut-off value was ≥ 0.1 IU/mL.
Measured: At Month 3, Month 10 and Month 11.
Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 10 and 100 Milli-International Units Per Milliliter (mIU/mL)
A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.
Measured: At Month 3, Month 10 and Month 11.
Concentrations for Anti-HBs.
A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.
Measured: At Month 3, Month 10 and Month 11.
Number of Subjects With Anti-poliovirus (Anti-polio) Types 1, 2 and 3 Above the Cut-off.
The anti-polio 1, 2 and 3 antibody concentrations cut-off value was ≥ 1:8.
Measured: At Month 3, Month 10 and Month 11.
Titers for Anti-polio 1, 2 and 3.
Titers were expressed as geometric mean titers (GMTs). The reference cut-off value was ≥ 1:8.
Measured: At Month 3, Month 10 and Month 11.
Number Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Above the Cut-off.
The reference cut-off for anti-PT, anti-FHA and anti-PRN antibody concentrations was ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliters (EL.U/mL).
Measured: At Month 3, Month 10 and Month 11.
Concentrations for Anti-PT, Anti-FHA and Anti-PRN.
Concentrations were expressed as geometric mean concentrations (GMCs). The reference cut-off value was ≥ 5 EL.U/mL.
Measured: At Month 3, Month 10 and Month 11.
Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN.
Booster response defined as: for initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL at Month 11; for initially seropositive subjects: antibody concentration at Month 11 ≥ 2 fold the pre-vaccination antibody concentration
Measured: At Month 11.
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs.
The anti-PNE antibody concentrations reference cut-offs were ≥ 0.2 and ≥ 0.05 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
Measured: At Month 3 and Month 11
Concentrations for Anti-PNE Serotypes.
Concentrations were expressed as geometric mean concentreations (GMCs). The reference cut-off value was ≥ 0.2 µg/mL.
Measured: At Month 3 and Month 11
Number of Subjects With Anti-PRP and rSBA-MenC Fold Increase Distribution.
The fold increase distribution cut-offs were: ≥2, ≥4, ≥6, ≥8 and ≥10.
Measured: At Month 11.
Number of Subjects Reporting Any Solicited Local Symptoms.
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.
Measured: During the 8-day (Days 0-7) post-vaccination period
Number of Subjects Reporting Any Solicited General Symptoms.
Solicited local symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever [axillary temperature above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any local symptom regardless of intensity grade.
Measured: During the 8-day (Days 0-7) post-vaccination period
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).
An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination.
Measured: Within the 31-day (Days 0-30) follow up period after vaccination
Number of Subjects Reporting Any Serious Adverse Events (SAEs).
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination.
Measured: During the entire study period (Month 0 to Month 11)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2010 (estimated)
- Study start17 May 2010
- Primary completion11 Oct 2011
- Study completion11 Oct 2011
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.
- Other trials for TetanusStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 480 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
- NCT01090453
- Sponsor's protocol ID
- 113615
- Status last verified
- Aug 2016
- First submitted
- 18 Mar 2010
- Last updated
- 20 Aug 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 4 and 12 Months of Age
- ClinicalTrials.gov ID
- NCT01090453
- Acronym / sponsor ID
- 113615
- Conditions
- Tetanus, Hepatitis B, Haemophilus Influenzae Type b, Poliomyelitis, Acellular Pertussis, Diphtheria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 17 May 2010
- Primary completion
- 11 Oct 2011 (actual)
- Study completion
- 11 Oct 2011 (actual)
- First posted
- 22 Mar 2010 (estimated)
- Results
- Posted 15 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083 vaccine co-administered with Prevenar 13® at 2, 4 and 12 months of age and with Rotarix™ at 2 and 4 months of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GSK2202083A Group | Experimental | Biological: GSK2202083A vaccine, Biological: Prevenar 13®, Biological: Rotarix™Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age. |
| Infanrix hexa Group | Active comparator | Biological: Prevenar 13®, Biological: Infanrix hexa™, Biological: Menjugate®, Biological: Rotarix™Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age. |
Who may qualify
- Ages
- 8 to 12 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
- A male or female infant between, and including, 8 and 12 weeks at the time of the first vaccination.
- Born after a gestation period of 36 to 42 weeks inclusive.
- Written informed consent obtained from the parent(s), Legally Acceptable Representative(s) of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Key exclusion criteria (15 listed)
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- Child in care.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Administration of a vaccine not foreseen by the study protocol within 30 days prior to randomisation, or planned administration from randomisation to the end of the study with the exception of inactivated influenza vaccines. The administration of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae type b, pneumococcal, rotavirus and/or MenC vaccines is not allowed at any time during the study period but other vaccines are allowed during the period from one day after study Visit 3 to 31 days before study Visit 4.
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 |
|---|---|---|
| GSK2202083A vaccine3 doses given at 2, 4 and 12 months of age | Biological | GSK2202083A Group |
| Prevenar 13®3 co-administered doses | Biological | GSK2202083A Group, Infanrix hexa Group |
| Infanrix hexa™3 doses given at 2, 4 and 12 months of age | Biological | Infanrix hexa Group |
| Menjugate®3 co-administered doses | Biological | Infanrix hexa Group |
| Rotarix™Oral, two doses | Biological | GSK2202083A Group, Infanrix hexa Group |
Primary outcome
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Above the Cut-off
Time frame: At Month 3
The anti-PRP antibody concentration cut-off for this assay was greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL).
Number of Subjects With Neisseria Meningitidis Using Baby Rabbit Complement (rSBA-MenC) Antibody Titers Above the Cut-off
Time frame: At Month 3
The rSBA-MenC antibody titers cut-off for this assay was ≥ 1:8.
20 secondary outcomes
Number of Subjects With Anti-PRP Antibody Concentrations Above the Cut-offs
Time frame: At Month 3, Month 10 and Month 11.
Number of Subjects With rSBA-MenC Antibody Titers Above the Cut-offs
Time frame: At Month 3, Month 10 and Month 11.
Concentrations for Anti-PRP.
Time frame: At Month 3, Month 10 and Month 11.
Titers for rSBA-MenC.
Time frame: At Month 3, Month 10 and Month 11.
Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies Above the Cut-off.
Time frame: At Month 3, Month 10 and Month 11.
Concentrations for Anti-T and Anti-D.
Time frame: At Month 3, Month 10 and Month 11.
Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 10 and 100 Milli-International Units Per Milliliter (mIU/mL)
Time frame: At Month 3, Month 10 and Month 11.
Concentrations for Anti-HBs.
Time frame: At Month 3, Month 10 and Month 11.
Number of Subjects With Anti-poliovirus (Anti-polio) Types 1, 2 and 3 Above the Cut-off.
Time frame: At Month 3, Month 10 and Month 11.
Titers for Anti-polio 1, 2 and 3.
Time frame: At Month 3, Month 10 and Month 11.
Number Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Above the Cut-off.
Time frame: At Month 3, Month 10 and Month 11.
Concentrations for Anti-PT, Anti-FHA and Anti-PRN.
Time frame: At Month 3, Month 10 and Month 11.
Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN.
Time frame: At Month 11.
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs.
Time frame: At Month 3 and Month 11
Concentrations for Anti-PNE Serotypes.
Time frame: At Month 3 and Month 11
Number of Subjects With Anti-PRP and rSBA-MenC Fold Increase Distribution.
Time frame: At Month 11.
Number of Subjects Reporting Any Solicited Local Symptoms.
Time frame: During the 8-day (Days 0-7) post-vaccination period
Number of Subjects Reporting Any Solicited General Symptoms.
Time frame: During the 8-day (Days 0-7) post-vaccination period
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).
Time frame: Within the 31-day (Days 0-30) follow up period after vaccination
Number of Subjects Reporting Any Serious Adverse Events (SAEs).
Time frame: During the entire study period (Month 0 to Month 11)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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
34 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GSK2202083A vaccine, Prevenar 13® and Infanrix hexa™ in people with Tetanus and Hepatitis B, run by GlaxoSmithKline at 34 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 15 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 20 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in Germany, France, Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 15 Aug 2014). 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 Anti-polyribosylribitol Phosphate (Anti-PRP) Above the Cut-off (time frame: At Month 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2018.