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Infections, MeningococcalPhase 3NCT01767376

Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Meningococcal Conjugate Vaccine (GSK134612) When Co-administered With Boostrix® in Subjects Between 11 and 25 Years of Age

A Phase 3 study testing Meningococcal vaccine GSK134612 and Boostrix® in people with Infections, Meningococcal, run by GlaxoSmithKline at 15 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to assess the immunogenicity, safety and reactogenicity of the meningococcal conjugate vaccine (MenACWY-TT) co-administered with Boostrix® versus each of the two vaccines given separately in healthy adolescents and young adults. Read more about this study

Who is it for?
Ages 11 to 25 yearsHealthy volunteers can take part
Conditions the study is for
Infections, Meningococcal
What is being tested?
Meningococcal vaccine GSK134612 and Boostrix®
Could I receive a placebo?
No, everyone receives an active treatment
How many people
692 participants
Where
15 sitesin 3 countries
Study dates
10 Jan 2013to 16 Jan 2014
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 25 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Subjects and subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
  • A male or female between, and including, 11 and 25 years of age at the time of the first vaccination.
  • Written informed consent obtained from the subject/from the parent(s)/LAR(s) of the subject.
  • Written informed assent obtained from the subjects when applicable according to local regulations.
  • Female subjects of non-childbearing potential may be enrolled in the study.
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  • Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy or ovariectomy.
  • Female subjects of childbearing potential may be enrolled in the study, if the subject:
  • has practiced adequate contraception for 30 days prior to vaccination, and
  • has a negative pregnancy test on the day of vaccination, and
  • has agreed to continue adequate contraception during the entire treatment period and for two months after completion of the vaccination series.

Who cannot join

  • Child in care.
  • Use of any investigational or non-registered product other than the study vaccines 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 within six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone ≥ 10 mg/day, or equivalent. Inhaled and topical steroids are allowed.
  • Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose of vaccine and ending 30 days after the last dose of vaccine, with the exception of licensed inactivated influenza vaccine.
  • 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.
  • Previous vaccination with a meningococcal vaccine.
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  • History of meningococcal disease.
  • Vaccination with a DTP-containing vaccine within the previous five years.
  • History of serious allergic reaction following any other DTP-containing vaccine or any component of the study vaccines.
  • History of encephalopathy within seven days following administration of a previous dose of pertussis vaccine that is not attributable to another identifiable cause.
  • Temperature of ≥ 40.5°C (105°F) within 48 hours of receipt of a previous dose of DTP vaccine, not due to another identifiable cause.
  • Collapse or shock-like state within 48 hours of receipt of a previous dose of DTP vaccine.
  • Seizures with or without fever within three days of a previous dose of DTP vaccine.
  • Severe Arthus-type hypersensitivity reactions following a prior dose of tetanus toxoid (TT) within the previous ten years.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination during the study period.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
  • Progressive neurologic disorder, uncontrolled epilepsy or progressive encephalopathy.
  • History of any neurologic disorders or seizures, including Guillain-Barré syndrome (GBS). History of a simple, single febrile seizure is permitted.
  • Bleeding disorders, such as haemophilia or thrombocytopenia, or subjects on anticoagulant therapy.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine, or planned administration during the study period.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.
  • Family history of congenital or hereditary immunodeficiency.
  • Major congenital defects or serious chronic illness.
  • Acute disease and/or fever at the time of enrolment.
  • Fever is defined as temperature ≥ 37.5°C /99.5°F for oral, axillary or tympanic route.
  • Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.

Trial locations and contacts

15 sites in 3 countries.

15 sites in 3 countries

Germany7 sites

  • GSK Investigational Site

    Bindlach, Bavaria, 95463

  • GSK Investigational Site

    Essen, North Rhine-Westphalia, 45359

  • GSK Investigational Site

    Frankenthal, Rhineland-Palatinate, 67227

  • GSK Investigational Site

    Goch, North Rhine-Westphalia, 47574

  • GSK Investigational Site

    Kehl, Baden-Wurttemberg, 77694

  • GSK Investigational Site

    Tuttlingen, Baden-Wurttemberg, 78532

  • GSK Investigational Site

    Würzburg, Bavaria, 97070

Other trials in Germany

South Korea7 sites

  • GSK Investigational Site

    Ansan, 425-707

  • GSK Investigational Site

    Incheon, 400 711

  • GSK Investigational Site

    Incheon, 700-711

  • GSK Investigational Site

    Jeonju Jeonbuk, 561-712

  • GSK Investigational Site

    Seoul, 130-702

  • GSK Investigational Site

    Seoul, 150-950

  • GSK Investigational Site

    Seoul, 158-710

Other trials in South Korea

Dominican Republic1 site

  • GSK Investigational Site

    Santo Domingo, Distrito Nacional

Other trials in Dominican Republic

About this study

Official title: Immunogenicity, Safety and Reactogenicity Study of GSK Biologicals' Meningococcal Conjugate Vaccine (GSK134612) When Co-administered With Boostrix® in Healthy Adolescents and Young Adults Between 11 and 25 Years of Age

The purpose of this study is to assess the immunogenicity, safety and reactogenicity of the meningococcal conjugate vaccine (MenACWY-TT) co-administered with Boostrix® versus each of the two vaccines given separately in healthy adolescents and young adults.

Being tested
Meningococcal vaccine GSK134612, Boostrix®
Keywords
Young adults, Adolescents, Reactogenicity, Diphtheria, pertussis, Immunogenicity, Tetanus, Meningococcal vaccines, Safety, Neisseria meningitidis, Healthy
Medical subject headings
Meningococcal Infections, Diphtheria, Whooping Cough, Tetanus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Meningococcal vaccine GSK134612Biological

    Also called MenACWY-TT, Nimenrix

    One dose administered intramuscularly (IM) in the deltoid muscle of the arm.

  • Boostrix®Biological

    Also called Tdap

    One dose administered intramuscularly (IM) in the deltoid of the right arm (in Co-ad Group) and left arm (in TdapACWY and ACWYTdap Groups).

Study groups in NCT01767376
Study groupRoleWhat they receive
Nimenrix+ Boostrix GroupExperimentalHealthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle.
Receives: Biological: Meningococcal vaccine GSK134612; Biological: Boostrix®
Nimenrix GroupExperimentalHealthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
Receives: Biological: Meningococcal vaccine GSK134612; Biological: Boostrix®
Boostrix GroupExperimentalHealthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Boostrix vaccine at Month 0 and one dose of Nimenrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
Receives: Biological: Meningococcal vaccine GSK134612; Biological: Boostrix®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA)

    The analysis was performed for the serogroups -MenA, -MenC -MenW-135 and -MenY. Antibody titers tabulated as geometric mean titers (GMTs), were obtained by serum bactericidal assay using rabbit complement and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The primary outcome results only refer to Nimenrix+Boostrix Group and Nimenrix Group.

    Measured: One month after Nimenrix vaccination (i.e. Month 1 for Nimenrix+Boostrix and Nimenrix Groups and Month 2 for Boostrix Group)

  2. Number of Subjects With Anti-D and Anti-T Concentrations Above the Cut-off Value

    The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as international units per milliliter (IU/mL). The reference cut-off value was an antibody concentration ≥ 1 IU/mL. The primary outcome results only refer to Nimenrix+Boostrix Group and Boostrix Group.

    Measured: One month after Boostrix vaccination (i.e. Month 1)

  3. Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations

    The antibody concentrations were tabulated as adjusted geometric mean concentrations (GMCs) and expressed as international units per millilitre (IU/mL). The primary outcome results only refer to Nimenrix+Boostrix Group and Boostrix Group

    Measured: One month after Boostrix vaccination (i.e. Month 1)

Secondary outcomes (11)

  1. Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres Above the Cut-off Values

    The reference cut-off values of the assay were rSBA-Men antibody concentrations ≥ 1:128 and ≥ 1:8.

    Measured: Prior to (i.e. Month 0 for Nimenrix+Boostrix and Nimenrix Groups and Month 1 for Boostrix Group) and one month after Nimenrix vaccination (i.e. Month 1 for Nimenrix+Boostrix and Nimenrix Groups and Month 2 for Boostrix Group)

  2. Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies

    rSBA vaccine response for serogroups A, C, W-135 and Y was defined as:

    • For initially seronegative subjects (pre-vaccination titer below the cut-off of 1:8): number of subjects with rSBA antibody titers ≥ 1:32 one month after vaccination.
    • For initially seropositive subjects (pre-vaccination titer ≥ 1:8): number of subjects with rSBA antibody titers at least four times the pre-vaccination antibody titers, one month after vaccination.

    Measured: One month after Nimenrix vaccination (i.e. Month 1 for Nimenrix+Boostrix and Nimenrix Groups and Month 2 for Boostrix Group)

  3. Anti-D Antibody Concentrations

    The antibody concentrations were tabulated as geometric mean concentrations (GMCs) and expressed as international units per milliliter (IU/mL).

    Measured: Prior to (PRE i.e. Month 0 for Nimenrix + Boostrix Group and Boostrix Group and Month 1 for Nimenrix Group) and one month after Boostrix vaccination (POST i.e. Month 1 for Nimenrix + Boostrix Group and Boostrix Group and Month 2 for Nimenrix Group)

  4. Anti-T Antibody Concentrations

    The antibody concentrations were tabulated as geometric mean concentrations (GMCs) and expressed as international units per milliliter (IU/mL).

    Measured: Prior to (i.e. Month 0 for Nimenrix + Boostrix Group and Boostrix Group and Month 1 for Nimenrix Group), one month after Nimenrix vaccination and one month after Boostrix vaccination

  5. Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Above the Cut-off Value

    The reference cut-off value of the assay was an antibody concentration ≥ 5.0 ELISA units per milliliter (EL.U/mL)

    Measured: Prior to (i.e. Month 0 for Nimenrix + Boostrix Group and Boostrix Group and Month 1 for Nimenrix Group) and one month after Boostrix vaccination (i.e. Month 1 for Nimenrix + Boostrix Group and Boostrix Group and Month 2 for Nimenrix Group)

  6. Booster Responses for Anti-PT, Anti-FHA and Anti-PRN Concentrations

    Booster response to the pertussis components is defined as:

    • For initially seronegative subjects, antibody concentration ≥ 4*cut_off (IU/mL) at one month post-vaccination;
    • For initially seropositive subjects with pre-vaccination antibody concentration < 4*cut_off (IU/mL) : antibody concentration at one month post-vaccination ≥ 4 fold the pre-vaccination antibody concentration;
    • For initially seropositive subjects with pre-vaccination antibody concentration ≥ 4*cut_off (IU/mL) : antibody concentration at one month post-vaccination ≥ 2 fold the pre-vaccination antibody concentration.

    Measured: One month after Boostrix vaccination (i.e. Month 1 for Nimenrix + Boostrix Group and Boostrix Group and Month 2 for Nimenrix Group)

  7. Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms

    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. Results are presented across doses, after each vaccination (with Nimenrix, Boostrix, total).

    Measured: During the 4-day (Days 0-3) following each vaccination

  8. Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms

    Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. Results are presented across doses.

    Measured: During the 4-day (Days 0-3) period following each vaccination

  9. Number of Subjects With New Onset of Chronic Diseases (NOCDs)

    NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.

    Measured: Throughout the study (Month 0 up to Month 2)

  10. Number of Subjects With Unsolicited Adverse Events AE(s)

    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

    Measured: During the 31-day (Days 0-30) post-vaccination period

  11. Number of Subjects With Serious Adverse Events SAE(s)

    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

    Measured: Throughout the study (Month 0 up to Month 2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2013 (estimated)
  2. Study start10 Jan 2013
  3. Primary completion16 Jan 2014
  4. Study completion16 Jan 2014

Resources

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
Single blind
Who is masked
Participant
Enrolment
692 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01767376
Sponsor's protocol ID
116705
Other IDs
2012-002737-11
Status last verified
Aug 2017
First submitted
21 Dec 2012
Last updated
6 Sep 2017
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Rivera L, Schwarz TF, Kim KH, Kim YK, Behre U, Cha SH, Jo DS, Lee J, Lee JS, Cheuvart B, Jastorff A, Van der Wielen M. Immunogenicity and safety of the quadrivalent meningococcal vaccine MenACWY-TT co-administered with a combined diphtheria-tetanus-acellular pertussis vaccine versus their separate administration in adolescents and young adults: A phase III, randomized study. Vaccine. 2018 Jul 25;36(31):4750-4758. doi: 10.1016/j.vaccine.2018.04.034. Epub 2018 Jun 28.

    PubMed 29960800

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Meningococcal vaccine GSK134612 and Boostrix® in people with Infections, Meningococcal, run by GlaxoSmithKline at 15 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 11 inclusion and 27 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 6 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Germany, South Korea, Dominican Republic. 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 6 Sep 2017). 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?

Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA) (time frame: One month after Nimenrix vaccination (i.e. Month 1 for Nimenrix+Boostrix and Nimenrix Groups and Month 2 for Boostrix Group)). 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 NCT01767376, 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 6 Sep 2017.

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