Infections, MeningococcalPhase 3NCT00465816
Primary Study to Demonstrate Non-inferiority and Immunogenicity of GSK Biologicals' Meningococcal Vaccine 134612
A Phase 3 study testing Nimenrix (Meningococcal vaccine 134612) and Twinrix in people with Infections, Meningococcal, run by GlaxoSmithKline at 6 sites in 2 countries.
Trial summary
This study will demonstrate the non-inferiority of GSK Biologicals' meningococcal vaccine 134612 when given in an experimental co-administration versus vaccine 134612 alone and versus the experimental co-administration alone in healthy subjects aged 11 through 17 years. There will be 3 groups in this study. Read more about this study
- Who is it for?
- Ages 11 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Infections, Meningococcal
- What is being tested?
- Nimenrix (Meningococcal vaccine 134612) and Twinrix
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 611 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 11 Apr 2007to 28 Apr 2008
- 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 11 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol
- A male or female between, and including, 11 and 17 years of age at the time of the first dose of vaccine.
- Written informed consent obtained from the subject/ from the parent or guardian of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Previously completed routine childhood vaccinations to the best of his/her/the parents'/guardians' knowledge.
- If the subject is female and of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after completion of the vaccination series.
Who cannot join
- Use of any investigational or non-registered product (drug or vaccine) 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 (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine.
- Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W-135 and/or Y within the last five years.
- Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup A, C, W-135 and/or Y.
- Previous vaccination with tetanus toxoid within the last month.
Show all 19Show fewer
- Previous vaccination with hepatitis A and/or hepatitis B vaccine.
- Seropositivity for hepatitis A IgG, hepatitis B surface antigen, hepatitis B core antibody and/or hepatitis B surface antigen at screening.
- History of hepatitis A, hepatitis B and/or Neisseria meningitidis infection.
- Known exposure to hepatitis A and/or hepatitis B virus within three months preceding the first dose of study vaccine.
- Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination.
- A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
- History of reactions or allergic disease likely to be exacerbated by any component of either vaccine.
- Major congenital defects or serious chronic illness.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the three months preceding the dose of study vaccine or planned administration during the study period.
- Pregnant or lactating female.
- History of chronic alcohol consumption and/or drug abuse.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Sweden5 sites
GSK Investigational Site
Karlskrona, SE-371 41
GSK Investigational Site
Linköping, SE-581 85
GSK Investigational Site
Malmö, SE-205 02
GSK Investigational Site
Örebro, SE-701 16
GSK Investigational Site
Umeå, SE-901 85
About this study
Official title: Non-inferiority of GSK Biologicals' Meningococcal Vaccine 134612 Given Concomitantly With GSK Biologicals' Twinrix™ Versus 134612 Alone and Twinrix™ Alone in Healthy Subjects Aged 11 Through 17 Years.
This study will demonstrate the non-inferiority of GSK Biologicals' meningococcal vaccine 134612 when given in an experimental co-administration versus vaccine 134612 alone and versus the experimental co-administration alone in healthy subjects aged 11 through 17 years. There will be 3 groups in this study.
Read the detailed description
All subjects of groups A and B will have 4 blood samples taken, all subjects of group C will have 3 blood samples taken.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.
- Conditions
- Infections, Meningococcal
- Being tested
- Nimenrix (Meningococcal vaccine 134612), Twinrix
- Keywords
- non-inferiority, adolescents, meningococcal vaccine
- Medical subject headings
- Meningococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nimenrix (Meningococcal vaccine 134612)Biological
Single dose intramuscular injection
TwinrixBiological
3-dose intramuscular injection. Twinrix Adult will be administered to subjects aged 16 years and above and Twinrix Junior will be administered to subjects aged from 11 years up to and including 15 years of age.
| Study group | Role | What they receive |
|---|---|---|
| Nimenrix + Twinrix Group | Experimental | Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6. Receives: Biological: Nimenrix (Meningococcal vaccine 134612); Biological: Twinrix |
| Nimenrix Group | Active comparator | Subjects received 1 dose of Nimenrix™ vaccine at Month 0. Receives: Biological: Nimenrix (Meningococcal vaccine 134612) |
| Twinrix Group | Active comparator | Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6. Receives: Biological: Twinrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Meningococcal Polysaccharide A Serum Bactericidal Antibodies/Assay, Using Baby Rabbit Complement for Assay (rSBA-MenA), rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers
The rSBA titers were expressed as geometric mean titers (GMTs).
Measured: At 1 month after vaccination with Nimenrix vaccine (Month 1)
Number of Subjects Seroconverted for Hepatitis A
A seroconverted subject was defined as a subject with anti-Hepatitis A virus (HAV) antibody concentration greater than or equal to 15 milli-International Units per Milliliter (mIU/mL) in previously seronegative subjects.
Measured: At 1 month after the third dose of Twinrix vaccine (Month 7)
Number of Subjects Seroprotected for Hepatitis B
A seroprotected subject was defined as a subject with anti-Hepatitis B surface antigen (HBs) antibody concentration greater than or equal to 10 milli-International Units per Milliliter (mIU/mL).
Measured: At 1 month after the third dose of Twinrix vaccine (Month 7)
Secondary outcomes (22)
Number of Subjects With a Vaccine Response to MenA, MenC, MenY and MenW-135
Vaccine response is defined as an rSBA titer of at least 1:32 in subjects initially seronegative [rSBA titer below1:8] and as a 4-fold increase in titer in subjects initially seropositive [rSBA titre greater than or equal to 1:8].
Measured: At 1 month after vaccination with Nimenrix vaccine (Month 1)
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values
The cut-off values assessed were greater than or equal to (≥) 1:8 and ≥ 1:128.
Measured: Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)
Anti-PSA (Polysaccharide A), Anti-PSC (Polysaccharide C), Anti-PSW-135 (Polysaccharide W-135), and Anti-PSY (Polysaccharide Y) Antibody Concentrations
Concentrations were provided as Geometric Mean Concentrations expressed as micrograms per milliliter (µg/mL).
Measured: Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values
The cut-off values assessed include greater than or equal to (≥) 0.3 micrograms per milliliter (µg/mL) and ≥ 2.0 µg/mL.
Measured: Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)
Anti-Tetanus Toxoid (TT) Antibody Concentrations
Concentrations were provided as Geometric Mean Concentrations expressed as International Units per milliliter (IU/mL).
Measured: Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)
Number of Subjects With Anti-tetanus Toxoid Antibody Concentrations Above the Pre-defines Cut-off Value
The cut-off value assessed was greater than or equal to 0.1 International Units per milliliter (IU/mL).
Measured: Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers at Month 7
The rSBA titers were expressed as geometric mean titers.
Measured: At 7 months after vaccination with Nimenrix (At Month 7)
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values at Month 7
The cut-off values assessed were greater than or equal to (≥) 1:8 and ≥ 1:128.
Measured: At 7 months after vaccination with Nimenrix (At Month 7)
Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations at Month 7
Concentrations were provided as Geometric Mean Concentrations expressed as micrograms per milliliter (µg/mL).
Measured: At 7 months after vaccination with Nimenrix (At Month 7)
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values at Month 7
The cut-off values assessed include greater than or equal to (≥) 0.3 micrograms per milliliter (µg/mL) and ≥ 2.0 µg/mL.
Measured: At 7 months after vaccination with Nimenrix (At Month 7)
Immunoglobulin G (IgG) Anti-HAV Antibody Concentrations
Concentrations are given as Geomatric Mean Concentrations expressed as milli-Internatinal Units per Milliliter (mIU/mL).
Measured: Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)
Number of Subjects With IgG Anti-HAV Antibody Concentrations Above the Pre-defined Cut-off Value
The cut-off value assessed was greater than or equal to 15 milli-Internatinal Units per Milliliter (mIU/mL).
Measured: Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)
IgG Anti-HBs Antibody Concentrations
Concentrations are given as Geomatric Mean Concentrations expressed as milli-Internatinal Units per Milliliter (mIU/mL).
Measured: Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)
Number of Subjects With IgG Anti-HB Antibody Concentrations Above the Pre-defined Cut-off Value
The cut-off value assessed was greater than or equal to 10 milli-Internatinal Units per Milliliter (mIU/mL).
Measured: Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)
Number of Subjects Reporting Any Solicited Local Symptoms Post-meningococcal Vaccination
Solicited local symptoms assessed include pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Measured: During a 4-day period (Days 0-3) after Nimenrix vaccination
Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination
Solicited local symptoms assessed include pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Measured: During a 4-day period (Days 0-3) after each Twinrix vaccination, and across doses
Number of Subjects Reporting Any Solicited General Symptoms
Solicited general symptoms assessed include fatigue, fever (axillary temperature greater than or equal to 37.5 degrees Celcius), gastrointestinal symptoms and headache. Any = occurrence of the symptom regardless of intensity grade. Dose 1 = post-Nimenrix and post-Twinrix for the Nimenrix + Twinrix Group, post-Twinrix for the Twinrix Group and post-Nimenrix for the Nimenrix Group, Dose 2, 3 and Across doses = post-Twinrix for the Nimenrix + Twinrix Group and for the Twinrix Group.
Measured: During a 4-day period (Days 0-3) after each vaccine dose and across doses
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
Unsolicited AE covers any AE 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.
Measured: Up to 1 month after each vaccine dose
Number of Subjects Reporting Any Specific AEs of New Onset of Chronic Illnesses
Specific AEs of new onset of chronic illnesses include e.g. autoimmune disorders, asthma, type I diabetes and allergies.
Measured: During the entire study (up to Month 7)
Number of Subjects Reporting Any Rash
Rashes include e.g. hives, idiopathic thrombocytopenic purpura, petechiae.
Measured: During the entire study (up to Month 7)
Number of Subjects Reporting Any Conditions Prompting Emergency Room Visits
Measured: During the entire study (up to Month 7)
Number of Subjects Reporting Any 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.
Measured: During the entire study (up to Month 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2007 (estimated)
- Study start11 Apr 2007
- Primary completion28 Apr 2008
- Study completion28 Apr 2008
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 (2)Papers the sponsor has linked to this study.
- Other trials for Infections, MeningococcalStudies 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
- 611 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
- NCT00465816
- Sponsor's protocol ID
- 109063
- Status last verified
- Nov 2016
- First submitted
- 24 Apr 2007
- Last updated
- 8 Jun 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
Ostergaard L, Silfverdal SA, Berglund J, Flodmark CE, West C, Bianco V, Baine Y, Miller JM. A tetravalent meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine is immunogenic and well-tolerated when co-administered with Twinrix((R)) in subjects aged 11-17 years: an open, randomised, controlled trial. Vaccine. 2012 Jan 17;30(4):774-83. doi: 10.1016/j.vaccine.2011.11.051. Epub 2011 Nov 19.
PubMed 22107850Ostergaard L et al. The Candidate meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugated vaccine (MenACWY-TT) co-administered with a combined hepatitis A and B vaccine (HepA/B) is immunogenic with an acceptable safety profile in subjects aged 11-17 Years. Abstract presented at the 3rd Northern European Conference on Travel Medicine (NECTM). Hamburg, Germany, 26-29 May 2010.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-inferiority of GSK Biologicals' Meningococcal Vaccine 134612 Given Concomitantly With GSK Biologicals' Twinrix™ Versus 134612 Alone and Twinrix™ Alone in Healthy Subjects Aged 11 Through 17 Years.
- ClinicalTrials.gov ID
- NCT00465816
- Acronym / sponsor ID
- 109063
- Conditions
- Infections, Meningococcal
- Keywords
- non-inferiority, adolescents, meningococcal vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 611 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 11 Apr 2007
- Primary completion
- 28 Apr 2008 (actual)
- Study completion
- 28 Apr 2008 (actual)
- First posted
- 25 Apr 2007 (estimated)
- Results
- Posted 22 May 2012
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 demonstrate the non-inferiority of GSK Biologicals' meningococcal vaccine 134612 when given in an experimental co-administration versus vaccine 134612 alone and versus the experimental co-administration alone in healthy subjects aged 11 through 17 years. There will be 3 groups in this study.
Detailed description
All subjects of groups A and B will have 4 blood samples taken, all subjects of group C will have 3 blood samples taken.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nimenrix + Twinrix Group | Experimental | Biological: Nimenrix (Meningococcal vaccine 134612), Biological: TwinrixSubjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6. |
| Nimenrix Group | Active comparator | Biological: Nimenrix (Meningococcal vaccine 134612)Subjects received 1 dose of Nimenrix™ vaccine at Month 0. |
| Twinrix Group | Active comparator | Biological: TwinrixSubjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6. |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol
- A male or female between, and including, 11 and 17 years of age at the time of the first dose of vaccine.
- Written informed consent obtained from the subject/ from the parent or guardian of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Previously completed routine childhood vaccinations to the best of his/her/the parents'/guardians' knowledge.
Key exclusion criteria (19 listed)
- Use of any investigational or non-registered product (drug or vaccine) 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 (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine.
- Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W-135 and/or Y within the last five years.
- Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup A, C, W-135 and/or Y.
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 |
|---|---|---|
| Nimenrix (Meningococcal vaccine 134612)Single dose intramuscular injection | Biological | Nimenrix + Twinrix Group, Nimenrix Group |
| Twinrix3-dose intramuscular injection. Twinrix Adult will be administered to subjects aged 16 years and above and Twinrix Junior will be administered to subjects aged from 11 years up to and including 15 years of age. | Biological | Nimenrix + Twinrix Group, Twinrix Group |
Primary outcome
Meningococcal Polysaccharide A Serum Bactericidal Antibodies/Assay, Using Baby Rabbit Complement for Assay (rSBA-MenA), rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers
Time frame: At 1 month after vaccination with Nimenrix vaccine (Month 1)
The rSBA titers were expressed as geometric mean titers (GMTs).
Number of Subjects Seroconverted for Hepatitis A
Time frame: At 1 month after the third dose of Twinrix vaccine (Month 7)
A seroconverted subject was defined as a subject with anti-Hepatitis A virus (HAV) antibody concentration greater than or equal to 15 milli-International Units per Milliliter (mIU/mL) in previously seronegative subjects.
Number of Subjects Seroprotected for Hepatitis B
Time frame: At 1 month after the third dose of Twinrix vaccine (Month 7)
A seroprotected subject was defined as a subject with anti-Hepatitis B surface antigen (HBs) antibody concentration greater than or equal to 10 milli-International Units per Milliliter (mIU/mL).
22 secondary outcomes
Number of Subjects With a Vaccine Response to MenA, MenC, MenY and MenW-135
Time frame: At 1 month after vaccination with Nimenrix vaccine (Month 1)
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values
Time frame: Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)
Anti-PSA (Polysaccharide A), Anti-PSC (Polysaccharide C), Anti-PSW-135 (Polysaccharide W-135), and Anti-PSY (Polysaccharide Y) Antibody Concentrations
Time frame: Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values
Time frame: Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)
Anti-Tetanus Toxoid (TT) Antibody Concentrations
Time frame: Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)
Number of Subjects With Anti-tetanus Toxoid Antibody Concentrations Above the Pre-defines Cut-off Value
Time frame: Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers at Month 7
Time frame: At 7 months after vaccination with Nimenrix (At Month 7)
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values at Month 7
Time frame: At 7 months after vaccination with Nimenrix (At Month 7)
Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations at Month 7
Time frame: At 7 months after vaccination with Nimenrix (At Month 7)
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values at Month 7
Time frame: At 7 months after vaccination with Nimenrix (At Month 7)
Immunoglobulin G (IgG) Anti-HAV Antibody Concentrations
Time frame: Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)
Number of Subjects With IgG Anti-HAV Antibody Concentrations Above the Pre-defined Cut-off Value
Time frame: Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)
IgG Anti-HBs Antibody Concentrations
Time frame: Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)
Number of Subjects With IgG Anti-HB Antibody Concentrations Above the Pre-defined Cut-off Value
Time frame: Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)
Number of Subjects Reporting Any Solicited Local Symptoms Post-meningococcal Vaccination
Time frame: During a 4-day period (Days 0-3) after Nimenrix vaccination
Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination
Time frame: During a 4-day period (Days 0-3) after each Twinrix vaccination, and across doses
Number of Subjects Reporting Any Solicited General Symptoms
Time frame: During a 4-day period (Days 0-3) after each vaccine dose and across doses
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
Time frame: Up to 1 month after each vaccine dose
Number of Subjects Reporting Any Specific AEs of New Onset of Chronic Illnesses
Time frame: During the entire study (up to Month 7)
Number of Subjects Reporting Any Rash
Time frame: During the entire study (up to Month 7)
Number of Subjects Reporting Any Conditions Prompting Emergency Room Visits
Time frame: During the entire study (up to Month 7)
Number of Subjects Reporting Any Serious Adverse Events (SAEs)
Time frame: During the entire study (up to Month 7)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22107850Ostergaard L, Silfverdal SA, Berglund J, Flodmark CE, West C, Bianco V, Baine Y, Miller JM. A tetravalent meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine is immunogenic and well-tolerated when co-administered with Twinrix((R)) in subjects aged 11-17 years: an open, randomised, controlled trial. Vaccine. 2012 Jan 17;30(4):774-83. doi: 10.1016/j.vaccine.2011.11.051. Epub 2011 Nov 19.
- BackgroundOstergaard L et al. The Candidate meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugated vaccine (MenACWY-TT) co-administered with a combined hepatitis A and B vaccine (HepA/B) is immunogenic with an acceptable safety profile in subjects aged 11-17 Years. Abstract presented at the 3rd Northern European Conference on Travel Medicine (NECTM). Hamburg, Germany, 26-29 May 2010.
- 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
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nimenrix (Meningococcal vaccine 134612) and Twinrix in people with Infections, Meningococcal, run by GlaxoSmithKline at 6 sites in 2 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 6 inclusion and 19 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 8 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Sweden, Denmark. 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 22 May 2012). 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?
Meningococcal Polysaccharide A Serum Bactericidal Antibodies/Assay, Using Baby Rabbit Complement for Assay (rSBA-MenA), rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers (time frame: At 1 month after vaccination with Nimenrix vaccine (Month 1)). 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 NCT00465816, which also lists 2 linked publications.
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 8 Jun 2018.