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CompletedNCT00465816Updated Jun 8, 2018Results posted

Primary Study to Demonstrate Non-inferiority and Immunogenicity of GSK Biologicals' Meningococcal Vaccine 134612

A Phase 3 interventional study of Nimenrix (Meningococcal vaccine 134612) and Twinrix in Infections, Meningococcal, sponsored by GlaxoSmithKline. Completed at 6 sites in 2 countries. Open to participants aged 11 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-08.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
611
Allocation
Randomized
Ages
11 Years to 17 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Infections, Meningococcal

Keywords

  • non-inferiority
  • adolescents
  • meningococcal vaccine
03

In context

Meningococcal Infections

219 studies on the registry are indexed under Meningococcal Infections; 6 are open to participants now.

This study's enrollment of 611 is above the median of 450 across 190 interventional studies indexed under Meningococcal Infections.

Browse Meningococcal Infections studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
11 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
611 participants (actual)

Study arms

  • Experimental
    Nimenrix + Twinrix Group

    Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.

    Biological: Nimenrix (Meningococcal vaccine 134612) · Biological: Twinrix

  • Active comparator
    Nimenrix Group

    Subjects received 1 dose of Nimenrix™ vaccine at Month 0.

    Biological: Nimenrix (Meningococcal vaccine 134612)

  • Active comparator
    Twinrix Group

    Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.

    Biological: Twinrix

Interventions

  • BiologicalNimenrix (Meningococcal vaccine 134612)

    Single dose intramuscular injection

  • BiologicalTwinrix

    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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: At 1 month after vaccination with Nimenrix vaccine (Month 1)

  2. 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.

    Time frame: At 1 month after the third dose of Twinrix vaccine (Month 7)

  3. 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).

    Time frame: At 1 month after the third dose of Twinrix vaccine (Month 7)

Secondary outcomes

  1. 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 \[rSBA titre greater than or equal to 1:8\].

    Time frame: At 1 month after vaccination with Nimenrix vaccine (Month 1)

  2. 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.

    Time frame: Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)

  3. 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).

    Time frame: Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)

  4. 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.

    Time frame: Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)

  5. Anti-Tetanus Toxoid (TT) Antibody Concentrations

    Concentrations were provided as Geometric Mean Concentrations expressed as International Units per milliliter (IU/mL).

    Time frame: Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)

  6. 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).

    Time frame: Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)

  7. rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers at Month 7

    The rSBA titers were expressed as geometric mean titers.

    Time frame: At 7 months after vaccination with Nimenrix (At Month 7)

  8. 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.

    Time frame: At 7 months after vaccination with Nimenrix (At Month 7)

  9. 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).

    Time frame: At 7 months after vaccination with Nimenrix (At Month 7)

  10. 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.

    Time frame: At 7 months after vaccination with Nimenrix (At Month 7)

  11. Immunoglobulin G (IgG) Anti-HAV Antibody Concentrations

    Concentrations are given as Geomatric Mean Concentrations expressed as milli-Internatinal Units per Milliliter (mIU/mL).

    Time frame: Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)

  12. 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).

    Time frame: Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)

  13. IgG Anti-HBs Antibody Concentrations

    Concentrations are given as Geomatric Mean Concentrations expressed as milli-Internatinal Units per Milliliter (mIU/mL).

    Time frame: Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)

  14. 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).

    Time frame: Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)

  15. 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.

    Time frame: During a 4-day period (Days 0-3) after Nimenrix vaccination

  16. 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.

    Time frame: During a 4-day period (Days 0-3) after each Twinrix vaccination, and across doses

  17. 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.

    Time frame: During a 4-day period (Days 0-3) after each vaccine dose and across doses

  18. 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.

    Time frame: Up to 1 month after each vaccine dose

  19. 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.

    Time frame: During the entire study (up to Month 7)

  20. Number of Subjects Reporting Any Rash

    Rashes include e.g. hives, idiopathic thrombocytopenic purpura, petechiae.

    Time frame: During the entire study (up to Month 7)

  21. Number of Subjects Reporting Any Conditions Prompting Emergency Room Visits

    Time frame: During the entire study (up to Month 7)

  22. 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.

    Time frame: During the entire study (up to Month 7)

07

Results

Posted May 22, 2012

Participant flow

Participant flow — Overall Study
MilestoneNimenrix + Twinrix GroupNimenrix GroupTwinrix Group
Started367122122
Completed367122120
Not completed002
Withdrew: Lost to follow-up002

Outcome measures

PrimaryMeningococcal 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).

Time frame:
At 1 month after vaccination with Nimenrix vaccine (Month 1)
Reported as:
Geometric mean · Titer
Meningococcal Polysaccharide A Serum Bactericidal Antibodies/Assay, Using Baby Rabbit Complement for Assay (rSBA-MenA), rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers
TiterNimenrix + Twinrix GroupNimenrix Group
rSBA-MenA5263.9 (4818.0 to 5751.0)5211.7 (4509.8 to 6022.8)
rSBA-MenC4344.6 (3800.3 to 4966.8)4926.9 (3684.8 to 6587.7)
rSBA-MenW-1358922.1 (8278.4 to 9615.9)8987.7 (7628.9 to 10588.6)
rSBA-MenY9291.5 (8537.7 to 10111.9)9492.8 (8172.4 to 11026.6)
Statistical analysis
  • Nimenrix + Twinrix Group vs Nimenrix Group · ANCOVA · Adjusted gmt ratio: 0.99 · 95% CI 0.8 to 1.22
  • Nimenrix + Twinrix Group vs Nimenrix Group · ANCOVA · Adjusted gmt ratio: 0.91 · 95% CI 0.68 to 1.21
  • Nimenrix + Twinrix Group vs Nimenrix Group · ANCOVA · Adjusted gmt ratio: 1.02 · 95% CI 0.87 to 1.19
  • Nimenrix + Twinrix Group vs Nimenrix Group · ANCOVA · Adjusted gmt ratio: 1.01 · 95% CI 0.85 to 1.19
PrimaryNumber 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.

Time frame:
At 1 month after the third dose of Twinrix vaccine (Month 7)
Reported as:
Count of participants · Participants
Number of Subjects Seroconverted for Hepatitis A
ParticipantsNimenrix + Twinrix GroupTwinrix Group
Number of Subjects Seroconverted for Hepatitis A32195
Statistical analysis
  • Nimenrix + Twinrix Group vs Twinrix Group · Percentage difference: 0 · 95% CI -1.19 to 3.9
PrimaryNumber 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).

Time frame:
At 1 month after the third dose of Twinrix vaccine (Month 7)
Reported as:
Count of participants · Participants
Number of Subjects Seroprotected for Hepatitis B
ParticipantsNimenrix + Twinrix GroupTwinrix Group
Number of Subjects Seroprotected for Hepatitis B32797
Statistical analysis
  • Nimenrix + Twinrix Group vs Twinrix Group · Percentage difference: -0.91 · 95% CI -2.64 to 2.92
SecondaryNumber 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 \[rSBA titre greater than or equal to 1:8\].

Time frame:
At 1 month after vaccination with Nimenrix vaccine (Month 1)
Reported as:
Count of participants · Participants
Number of Subjects With a Vaccine Response to MenA, MenC, MenY and MenW-135
ParticipantsNimenrix + Twinrix GroupNimenrix Group
rSBA-MenA24676
rSBA-MenC333101
rSBA-MenW-135346112
rSBA-MenY335105
SecondaryNumber 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.

Time frame:
Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)
Reported as:
Count of participants · Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values
ParticipantsNimenrix + Twinrix GroupNimenrix Group
rSBA-MenA ≥ 1:8 [Month 0]10533
rSBA-MenA ≥ 1:8 [Month 1]352113
rSBA-MenC ≥ 1:8 [Month 0]18767
rSBA-MenC ≥ 1:8 [Month 1]359114
rSBA-MenW-135 ≥ 1:8 [Month 0]27796
rSBA-MenW-135 ≥ 1:8 [Month 1]360115
rSBA-MenY ≥ 1:8 [Month 0]27595
rSBA-MenY ≥ 1:8 [Month 1]359115
rSBA-MenA ≥ 1:128 [Month 0]9130
rSBA-MenA ≥ 1:128 [Month 1]352113
rSBA-MenC ≥ 1:128 [Month 0]12244
rSBA-MenC ≥ 1:128 [Month 1]358113
rSBA-MenW-135 ≥ 1:128 [Month 0]18064
rSBA-MenW-135 ≥ 1:128 [Month 1]359115
rSBA-MenY ≥ 1:128 [Month 0]21880
rSBA-MenY ≥ 1:128 [Month 1]359115
SecondaryAnti-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).

Time frame:
Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)
Reported as:
Geometric mean · micrograms per milliliter (µg/mL)
Anti-PSA (Polysaccharide A), Anti-PSC (Polysaccharide C), Anti-PSW-135 (Polysaccharide W-135), and Anti-PSY (Polysaccharide Y) Antibody Concentrations
micrograms per milliliter (µg/mL)Nimenrix + Twinrix GroupNimenrix Group
Anti-PSA [Month 0]0.25 (0.21 to 0.30)0.24 (0.19 to 0.31)
Anti-PSA [Month 1]27.23 (22.91 to 32.38)18.47 (12.02 to 28.38)
Anti-PSC [Month 0]0.22 (0.19 to 0.26)0.26 (0.19 to 0.35)
Anti-PSC [Month 1]18.58 (15.44 to 22.37)21.15 (14.87 to 30.09)
Anti-PSW-135 [Month 0]0.19 (0.17 to 0.21)0.16 (0.15 to 0.17)
Anti-PSW-135 [Month 1]6.78 (5.52 to 8.32)6.72 (4.62 to 9.76)
Anti-PSY [Month 0]0.22 (0.18 to 0.25)0.17 (0.14 to 0.21)
Anti-PSY [Month 1]14.04 (11.52 to 17.10)12.50 (8.49 to 18.41)
SecondaryNumber 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.

Time frame:
Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)
Reported as:
Count of participants · Participants
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values
ParticipantsNimenrix + Twinrix GroupNimenrix Group
Anti-PSA ≥ 0.3 µg/mL [Month 0]4513
Anti-PSA ≥ 0.3 µg/mL [Month 1]17954
Anti-PSC ≥ 0.3 µg/mL [Month 0]3213
Anti-PSC ≥ 0.3 µg/mL [Month 1]17954
Anti-PSW-135 ≥ 0.3 µg/mL [Month 0]192
Anti-PSW-135 ≥ 0.3 µg/mL [Month 1]17656
Anti-PSY ≥ 0.3 µg/mL [Month 0]242
Anti-PSY ≥ 0.3 µg/mL [Month 1]17854
Anti-PSA ≥ 2.0 µg/mL [Month 0]143
Anti-PSA ≥ 2.0 µg/mL [Month 1]17852
Anti-PSC ≥ 2.0 µg/mL [Month 0]106
Anti-PSC ≥ 2.0 µg/mL [Month 1]17653
Anti-PSW-135 ≥ 2.0 µg/mL [Month 0]30
Anti-PSW-135 ≥ 2.0 µg/mL [Month 1]14648
Anti-PSY ≥ 2.0 µg/mL [Month 0]102
Anti-PSY ≥ 2.0 µg/mL [Month 1]17251
SecondaryAnti-Tetanus Toxoid (TT) Antibody Concentrations

Concentrations were provided as Geometric Mean Concentrations expressed as International Units per milliliter (IU/mL).

Time frame:
Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)
Reported as:
Geometric mean · International Units per milliliter
Anti-Tetanus Toxoid (TT) Antibody Concentrations
International Units per milliliterNimenrix + Twinrix GroupNimenrix Group
Month 00.800 (0.692 to 0.926)1.020 (0.795 to 1.308)
Month 116.794 (15.318 to 18.411)17.252 (14.603 to 20.381)
SecondaryNumber 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).

Time frame:
Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)
Reported as:
Count of participants · Participants
Number of Subjects With Anti-tetanus Toxoid Antibody Concentrations Above the Pre-defines Cut-off Value
ParticipantsNimenrix + Twinrix GroupNimenrix Group
Month 0293111
Month 1354112
SecondaryrSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers at Month 7

The rSBA titers were expressed as geometric mean titers.

Time frame:
At 7 months after vaccination with Nimenrix (At Month 7)
Reported as:
Geometric mean · Titer
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers at Month 7
TiterNimenrix + Twinrix GroupNimenrix Group
rSBA-MenA2121.6 (1913.5 to 2352.2)2298.3 (1909.0 to 2767.0)
rSBA-MenC952.4 (826.2 to 1097.8)1053.9 (803.1 to 1382.9)
rSBA-MenW-1353283.4 (2998.4 to 3595.4)3497.7 (3008.0 to 4067.2)
rSBA-MenY4432.7 (4027.4 to 4878.8)4455.6 (3821.4 to 5195.1)
SecondaryNumber 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.

Time frame:
At 7 months after vaccination with Nimenrix (At Month 7)
Reported as:
Count of participants · Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values at Month 7
ParticipantsNimenrix + Twinrix GroupNimenrix Group
rSBA-MenA ≥ 1:8330107
rSBA-MenC ≥ 1:8332110
rSBA-MenW-135 ≥ 1:8334112
rSBA-MenY ≥ 1:8333112
rSBA-MenA ≥ 1:128329107
rSBA-MenC ≥ 1:128318108
rSBA-MenW-135 ≥ 1:128333112
rSBA-MenY ≥ 1:128332112
SecondaryAnti-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).

Time frame:
At 7 months after vaccination with Nimenrix (At Month 7)
Reported as:
Geometric mean · micrograms per milliliter (µg/mL)
Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations at Month 7
micrograms per milliliter (µg/mL)Nimenrix + Twinrix GroupNimenrix Group
Anti-PSA4.14 (3.34 to 5.15)3.88 (2.44 to 6.16)
Anti-PSC3.28 (2.60 to 4.14)4.15 (2.59 to 6.67)
Anti-PSW-1352.46 (1.99 to 3.05)3.08 (2.11 to 4.50)
Anti-PSY3.76 (2.95 to 4.78)4.28 (2.90 to 6.31)
SecondaryNumber 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.

Time frame:
At 7 months after vaccination with Nimenrix (At Month 7)
Reported as:
Count of participants · Participants
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
ParticipantsNimenrix + Twinrix GroupNimenrix Group
Anti-PSA ≥ 0.3 µg/mL16052
Anti-PSC ≥ 0.3 µg/mL15752
Anti-PSW-135 ≥ 0.3 µg/mL15751
Anti-PSY ≥ 0.3 µg/mL15453
Anti-PSA ≥ 2.0 µg/mL11034
Anti-PSC ≥ 2.0 µg/mL9435
Anti-PSW-135 ≥ 2.0 µg/mL9341
Anti-PSY ≥ 2.0 µg/mL10437
SecondaryImmunoglobulin G (IgG) Anti-HAV Antibody Concentrations

Concentrations are given as Geomatric Mean Concentrations expressed as milli-Internatinal Units per Milliliter (mIU/mL).

Time frame:
Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)
Reported as:
Geometric mean · milli-Internatinal Units per Milliliter
Immunoglobulin G (IgG) Anti-HAV Antibody Concentrations
milli-Internatinal Units per MilliliterNimenrix + Twinrix GroupTwinrix Group
Month 07.9 (7.6 to 8.1)7.6 (7.4 to 7.9)
Month 75876.7 (5362.9 to 6439.8)6739.0 (5757.4 to 7887.9)
SecondaryNumber 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).

Time frame:
Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)
Reported as:
Count of participants · Participants
Number of Subjects With IgG Anti-HAV Antibody Concentrations Above the Pre-defined Cut-off Value
ParticipantsNimenrix + Twinrix GroupTwinrix Group
Month 0102
Month 733197
SecondaryIgG Anti-HBs Antibody Concentrations

Concentrations are given as Geomatric Mean Concentrations expressed as milli-Internatinal Units per Milliliter (mIU/mL).

Time frame:
Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)
Reported as:
Geometric mean · milli-Internatinal Units per Milliliter
IgG Anti-HBs Antibody Concentrations
milli-Internatinal Units per MilliliterNimenrix + Twinrix GroupTwinrix Group
Month 01.7 (1.6 to 1.7)1.7 (1.6 to 1.8)
Month 76088.2 (4977.5 to 7446.7)7654.7 (5518.8 to 10617.3)
SecondaryNumber 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).

Time frame:
Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)
Reported as:
Count of participants · Participants
Number of Subjects With IgG Anti-HB Antibody Concentrations Above the Pre-defined Cut-off Value
ParticipantsNimenrix + Twinrix GroupTwinrix Group
Month 010
Month 732797
SecondaryNumber 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.

Time frame:
During a 4-day period (Days 0-3) after Nimenrix vaccination
Reported as:
Count of participants · Participants
Number of Subjects Reporting Any Solicited Local Symptoms Post-meningococcal Vaccination
ParticipantsNimenrix + Twinrix GroupNimenrix Group
Pain18158
Redness7519
Swelling7118
SecondaryNumber 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.

Time frame:
During a 4-day period (Days 0-3) after each Twinrix vaccination, and across doses
Reported as:
Count of participants · Participants
Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination
ParticipantsNimenrix + Twinrix GroupTwinrix Group
Any Pain, Dose 114352
Any Redness, Dose 1369
Any Swelling, Dose 1184
Any Pain, Dose 29934
Any Redness, Dose 2276
Any Swelling, Dose 2125
Any Pain, Dose 314341
Any Redness, Dose 33014
Any Swelling, Dose 32915
Any Pain, Across doses22873
Any Redness, Across doses6319
Any Swelling, Across doses4919
SecondaryNumber 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.

Time frame:
During a 4-day period (Days 0-3) after each vaccine dose and across doses
Reported as:
Count of participants · Participants
Number of Subjects Reporting Any Solicited General Symptoms
ParticipantsNimenrix + Twinrix GroupNimenrix GroupTwinrix Group
Any Fatigue, Dose 11013033
Any Temperature (Axillary), Dose 1910
Any Gastrointestinal symptoms, Dose 1441015
Any Headache, Dose 1882632
Any Fatigue, Dose 247—15
Any Temperature (Axillary), Dose 24—1
Any Gastrointestinal symptoms, Dose 228—8
Any Headache, Dose 249—13
Any Fatigue, Dose 363—21
Any Temperature (Axillary), Dose 36—3
Any Gastrointestinal symptoms, Dose 321—7
Any Headache, Dose 353—23
Any Fatigue, Across doses149—48
Any Temperature (Axillary), Across doses17—4
Any Gastrointestinal symptoms, Across doses72—23
Any Headache, Across doses126—48
SecondaryNumber 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.

Time frame:
Up to 1 month after each vaccine dose
Reported as:
Count of participants · Participants
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
ParticipantsNimenrix + Twinrix GroupNimenrix GroupTwinrix Group
Post Dose 1621318
Post Dose 226NA7
Post Dose 352NA16
SecondaryNumber 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.

Time frame:
During the entire study (up to Month 7)
Reported as:
Count of participants · Participants
Number of Subjects Reporting Any Specific AEs of New Onset of Chronic Illnesses
ParticipantsNimenrix + Twinrix GroupNimenrix GroupTwinrix Group
Number of Subjects Reporting Any Specific AEs of New Onset of Chronic Illnesses502
SecondaryNumber of Subjects Reporting Any Rash

Rashes include e.g. hives, idiopathic thrombocytopenic purpura, petechiae.

Time frame:
During the entire study (up to Month 7)
Reported as:
Count of participants · Participants
Number of Subjects Reporting Any Rash
ParticipantsNimenrix + Twinrix GroupNimenrix GroupTwinrix Group
Number of Subjects Reporting Any Rash501
SecondaryNumber of Subjects Reporting Any Conditions Prompting Emergency Room Visits
Time frame:
During the entire study (up to Month 7)
Reported as:
Count of participants · Participants
Number of Subjects Reporting Any Conditions Prompting Emergency Room Visits
ParticipantsNimenrix + Twinrix GroupNimenrix GroupTwinrix Group
Number of Subjects Reporting Any Conditions Prompting Emergency Room Visits100
SecondaryNumber 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.

Time frame:
During the entire study (up to Month 7)
Reported as:
Count of participants · Participants
Number of Subjects Reporting Any Serious Adverse Events (SAEs)
ParticipantsNimenrix + Twinrix GroupNimenrix GroupTwinrix Group
Number of Subjects Reporting Any Serious Adverse Events (SAEs)401

Adverse events

Collected over Serious Adverse Events were reported throughout the entire study period (up to Month 7). Unsolicited Adverse Events were reported up to one month after each vaccine dose. Other Frequent (non-serious) Adverse Events were reported during a 4-day follow-up period after any vaccine dose.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Nimenrix + Twinrix Group0/367 (0%)4/367 (1.1%)312/367 (85%)
Nimenrix Group0/122 (0%)0/122 (0%)82/122 (67.2%)
Twinrix Group0/122 (0%)1/122 (0.8%)100/122 (82%)
Most frequent serious events
Most frequent serious events
EventNimenrix + Twinrix GroupNimenrix GroupTwinrix Group
Brain contusionInjury, poisoning and procedural complications0/3670/1221/122
ConcussionInjury, poisoning and procedural complications1/3670/1220/122
Drug toxicityInjury, poisoning and procedural complications1/3670/1220/122
HydrocephalusNervous system disorders1/3670/1220/122
SyncopeNervous system disorders1/3670/1220/122
DepressionPsychiatric disorders1/3670/1220/122
Most frequent other events
Most frequent other events
EventNimenrix + Twinrix GroupNimenrix GroupTwinrix Group
Pain at the injection siteGeneral disorders228/3670/12273/122
Pain at the injection siteGeneral disorders181/36758/122—
FatigueGeneral disorders149/36730/12248/122
HeadacheGeneral disorders126/36726/12248/122
Redness at the injection siteGeneral disorders75/36719/122—
Gastrointestinal symptomsGeneral disorders72/36710/12223/122
Redness at the injection siteGeneral disorders63/3670/12219/122
Swelling at the injection siteGeneral disorders62/36718/122—
Swelling at the injection siteGeneral disorders49/3670/12219/122

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Nimenrix + Twinrix GroupNimenrix GroupTwinrix GroupTotal
Mean14.3 ± 1.8914.3 ± 1.8414.3 ± 1.9414.3 ± 1.89
Sex: Female, Male
Sex: Female, Male(Participants)Nimenrix + Twinrix GroupNimenrix GroupTwinrix GroupTotal
Female1956168324
Male1726154287
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Nimenrix + Twinrix GroupNimenrix GroupTwinrix GroupTotal
African heritage/African American1001
Asian - central/south Asian heritage1203
Asian - east Asian heritage2204
Asian - south east Asian heritage0011
White - Arabic/north African heritage1102
White - Caucasian/European heritage361117121599
Not specified1001
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Study locations

6 sites
  • GSK Investigational Site
    Aarhus N, 8200, Denmark
  • GSK Investigational Site
    Karlskrona, SE-371 41, Sweden
  • GSK Investigational Site
    Linköping, SE-581 85, Sweden
  • GSK Investigational Site
    Malmö, SE-205 02, Sweden
  • GSK Investigational Site
    Umeå, SE-901 85, Sweden
  • GSK Investigational Site
    Örebro, SE-701 16, Sweden
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References and documents

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 22107850 ↗
  • Ostergaard 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.

Individual participant data

Plan to share: 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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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00465816
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Apr 25, 2007
Start date
Apr 11, 2007
Primary completion
Apr 28, 2008
Completion
Apr 28, 2008
Results posted
May 22, 2012
Last update
Jun 8, 2018

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

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