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CompletedNCT00674583Updated Nov 18, 2019Results posted

Comparison of GSK Biologicals' Meningococcal Vaccine (GSK134612) and Licensed MenC-CRM197 Vaccine in Healthy Children

A Phase 3 interventional study of GSK Biologicals' meningococcal vaccine GSK134612 and Menjugate in Infections, Meningococcal, sponsored by GlaxoSmithKline. Completed at 31 sites in 2 countries. Open to participants aged 2 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-18.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
414
Allocation
Randomized
Ages
2 Years to 10 Years
Sex
All
01

Study summary

The purpose of the study is to investigate whether or not GSK Biologicals' meningococcal vaccine GSK134612 is inferior to a licensed MenC-CRM197 conjugate vaccine in terms of vaccine antibody response against meningococcal serogroup C disease.

Read the detailed description

The study has 2 study groups. One group will receive one dose of GSK Biologicals' vaccine GSK 134612 and the other group will receive one dose of licensed MenC-CRM197 vaccine. All subjects will have 2 blood samples taken: just before vaccination and one month after vaccination.

02

Conditions studied

  • Infections, Meningococcal

Keywords

  • Conjugate vaccine
  • Meningococcal disease
  • Immunogenicity
  • Meningococcal vaccine
  • Safety
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 414 is close to 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
2 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Subjects whose parents/guardians, the investigator believes can and will comply with the requirements of the protocol.
  • A male or female between, and including, 2 and 10 years of age at the time of the vaccination.
  • Written informed consent obtained from the parent(s) or guardian of the subject.
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.
  • Previously completed routine childhood vaccinations to the best of his/her parents'/guardians' knowledge.

Exclusion criteria

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the study vaccine dose, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose..
  • Administration of a vaccine not foreseen by the study protocol during the period starting from one month before the dose of the study vaccine and ending 30 days after.
  • Concurrently participating in another clinical study or planned participation 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 meningococcal polysaccharide vaccine of serogroup A, C W-135 and/or Y (for subjects below 6 years) or within the last five years (for subjects 6 years old and above).
  • Previous vaccination with meningococcal polysaccharide conjugate vaccine serogroups A, C, W-135 and/or Y.
  • History of meningococcal disease.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, 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 allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Major congenital defects or serious chronic illness.
  • History of any neurologic disorders or seizures.
  • Acute disease at the time of enrolment
  • Administration of immunoglobulins and/or any blood products within the three months preceding the study vaccine dose or planned administration during the study period.

Exclusion criteria for specified regions in France

  • Subjects in contact with somebody suffering from an invasive infection with meningococcal serogroups A, C, Y or W-135, or
  • Subjects living in a geographic area in France where local outbreak with meningococcal serogroup C has occurred and would thus be likely to participate in a vaccination campaign against meningococcal serogroup C.
05

Study design

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

Study arms

  • Experimental
    Nimenrix Group

    Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Nimenrix™ vaccine into the non-dominant deltoid region, at Day 0.

    Biological: GSK Biologicals' meningococcal vaccine GSK134612

  • Active comparator
    Menjugate Group

    Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Menjugate® vaccine into the non-dominant thigh region, at Day 0.

    Biological: Menjugate

Interventions

  • BiologicalGSK Biologicals' meningococcal vaccine GSK134612

    Intramuscular administration, 1 dose

  • BiologicalMenjugate

    Intramuscular administration, 1 dose

    Also known as: MenC-CRM197vaccine

06

What researchers measure

Primary outcomes

  1. Number of Subjects With Vaccine Response to Meningococcal Serogroup C Serum Based on a Bactericidal Assay Using Baby Rabbit Complement (rSBA-MenC) Antibody

    Vaccine response to MenC was defined as: -for initially seronegative subjects \[i.e. rSBA-MenC titer below (\<) 1:8\], antibody titer greater than or equal to (≥) 1:32; -for initially seropositive (i.e. rSBA-MenC titer ≥ 1:8), antibody titer post-vaccination ≥ 4-fold the pre-vaccination antibody titer.

    Time frame: One month after vaccination (Month 1)

Secondary outcomes

  1. Meningococcal Serogroup A (rSBA) Antibody Titers by Serogroup

    Antibody titers were presented as geometric mean titers (GMTs).

    Time frame: Prior to (Month 0) and one month after vaccination (Month 1)

  2. Anti-meningococcal Serogroup Polysaccharides (Anti-PS) Antibody Concentrations

    Anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY antibody concentrations were presented as geometric mean concentrations (GMCs) and tabulated as micrograms per milliliter (μg/mL).

    Time frame: Prior to (Month 0) and one month after vaccination (Month 1)

  3. Number of Subjects Between 2 and 5 Years of Age With Any and Grade 3 Solicited Local Symptoms

    Solicited symptoms assessed were: pain, redness and swelling. Any = occurrence of any local symptom regardless of their intensity grade. Grade 3 Pain = cried when limb was moved/spontaneously painful. Grade 3 Redness and Swelling= redness/swelling spreading beyond (\>) 30 millimeters (mm).

    Time frame: During the 4-day (Days 0-3) post-vaccination period

  4. Number of Subjects Between 6 and 10 Years of Age With Any and Grade 3 Solicited Local Symptoms

    Solicited symptoms assessed were: pain, redness and swelling. Any = occurrence of any local symptom regardless of their intensity grade. Grade 3 Pain = pain that prevented normal activity. Grade 3 Redness and Swelling= redness/swelling spreading beyond (\>) 50 millimeters (mm).

    Time frame: During the 4-day (Days 0-3) post-vaccination period

  5. Number of Subjects Between 2 and 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms

    Solicited general symptoms assessed were drowsiness, fever \[defined as oral temperature ≥ 37.5 degrees Celsius (°C)\], irritability and loss of appetite. Any = occurrence of the general symptom regardless of intensity grade and relationship to vaccination. Grade 3 Symptom = symptom that prevented normal activity. Grade 3 Loss of appetite = did not eat at all. Grade 3 Fever = fever \> 39.5°C. Related = general symptoms assessed by the investigator as causally related to vaccination

    Time frame: During the 4-day (Days 0-3) post-vaccination period

  6. Number of Subjects Between 6 and 10 Years of Age With Any, Grade 3 and Related Solicited General Symptoms

    Solicited general symptoms assessed were drowsiness, fever \[defined as oral temperature ≥ 37.5 degrees Celsius (°C)\], irritability and loss of appetite. Any = occurrence of the general symptom regardless of intensity grade and relationship to vaccination. Grade 3 Symptom = symptom that prevented normal activity. Grade 3 Loss of appetite = did not eat at all. Grade 3 Fever = fever \> 39.5°C. Related = general symptoms assessed by the investigator as causally related to vaccination

    Time frame: During the 4-day (Days 0-3) post-vaccination period

  7. Number of Subjects Reporting Specific Adverse Events

    Specific AEs included: - rash (hives, idiopathic thrombocytopenic purpura, petechiae); - new onset of chronic illness(es) (NOCI) (e.g. autoimmune disorders, asthma, type I diabetes and allergies); - conditions prompting emergency room (ER) visits.

    Time frame: Up to 6 months after vaccination (Month 6)

  8. Number of Subjects With Any Unsolicited Adverse Events (AEs)

    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.

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

  9. Number of Subjects With 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: Up to six months after vaccination (Month 6)

07

Results

Posted Oct 19, 2017

Participant flow

Participant flow — Overall Study
MilestoneNimenrix GroupMenjugate Group
Started311103
Completed311103
Not completed00

Outcome measures

PrimaryNumber of Subjects With Vaccine Response to Meningococcal Serogroup C Serum Based on a Bactericidal Assay Using Baby Rabbit Complement (rSBA-MenC) Antibody

Vaccine response to MenC was defined as: -for initially seronegative subjects \[i.e. rSBA-MenC titer below (\<) 1:8\], antibody titer greater than or equal to (≥) 1:32; -for initially seropositive (i.e. rSBA-MenC titer ≥ 1:8), antibody titer post-vaccination ≥ 4-fold the pre-vaccination antibody titer.

Time frame:
One month after vaccination (Month 1)
Reported as:
Count of participants · Participants
Number of Subjects With Vaccine Response to Meningococcal Serogroup C Serum Based on a Bactericidal Assay Using Baby Rabbit Complement (rSBA-MenC) Antibody
ParticipantsNimenrix GroupMenjugate Group
Number of Subjects With Vaccine Response to Meningococcal Serogroup C Serum Based on a Bactericidal Assay Using Baby Rabbit Complement (rSBA-MenC) Antibody25488
Statistical analysis
  • Nimenrix Group vs Menjugate Group · Difference in percentage: -0.88 · 95% CI -5.25 to 5.75
SecondaryMeningococcal Serogroup A (rSBA) Antibody Titers by Serogroup

Antibody titers were presented as geometric mean titers (GMTs).

Time frame:
Prior to (Month 0) and one month after vaccination (Month 1)
Reported as:
Geometric mean · Titers
Meningococcal Serogroup A (rSBA) Antibody Titers by Serogroup
TitersNimenrix GroupMenjugate Group
rSBA-MenA, Month 031.5 (23.3 to 42.5)25.9 (15.6 to 43)
rSBA-MenA, Month 16236.1 (5574.5 to 6976.3)27.2 (15.6 to 47.4)
rSBA-MenC, Month 022.7 (18.1 to 28.4)19.4 (13.1 to 28.8)
rSBA-MenC, Month 12794.8 (2393.5 to 3263.3)5291.6 (3814.6 to 7340.5)
rSBA-MenW-135, Month 083.2 (67.9 to 102)70.2 (48.5 to 101.6)
rSBA-MenW-135, Month 18549.5 (7618.5 to 9594.3)87.3 (58.5 to 130.4)
rSBA-MenY, Month 0153.6 (125.3 to 188.3)107.4 (71.4 to 161.6)
rSBA-MenY, Month 18360.7 (7447.3 to 9386.1)128.2 (83.8 to 196.2)
SecondaryAnti-meningococcal Serogroup Polysaccharides (Anti-PS) Antibody Concentrations

Anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY antibody concentrations were presented as geometric mean concentrations (GMCs) and tabulated as micrograms per milliliter (μg/mL).

Time frame:
Prior to (Month 0) and one month after vaccination (Month 1)
Reported as:
Geometric mean · μg/mL
Anti-meningococcal Serogroup Polysaccharides (Anti-PS) Antibody Concentrations
μg/mLNimenrix GroupMenjugate Group
Anti-PSA, Month 00.2 (0.17 to 0.22)0.22 (0.17 to 0.29)
Anti-PSA, Month 132.45 (26.57 to 39.63)0.31 (0.19 to 0.49)
Anti-PSc, Month 00.18 (0.16 to 0.2)0.2 (0.16 to 0.25)
Anti-PSc, Month 114.95 (12.89 to 17.34)18.07 (13.88 to 23.51)
Anti-PSW-135, Month 00.17 (0.15 to 0.18)0.17 (0.14 to 0.2)
Anti-PSW-135, Month 16.96 (5.72 to 8.47)0.18 (0.15 to 0.22)
Anti-PSY, Month 00.16 (0.15 to 0.17)0.16 (0.15 to 0.17)
Anti-PSY, Month 114.15 (11.66 to 17.17)0.17 (0.15 to 0.19)
SecondaryNumber of Subjects Between 2 and 5 Years of Age With Any and Grade 3 Solicited Local Symptoms

Solicited symptoms assessed were: pain, redness and swelling. Any = occurrence of any local symptom regardless of their intensity grade. Grade 3 Pain = cried when limb was moved/spontaneously painful. Grade 3 Redness and Swelling= redness/swelling spreading beyond (\>) 30 millimeters (mm).

Time frame:
During the 4-day (Days 0-3) post-vaccination period
Reported as:
Count of participants · Participants
Number of Subjects Between 2 and 5 Years of Age With Any and Grade 3 Solicited Local Symptoms
ParticipantsNimenrix Group (< 6 Years)Menjugate Group (< 6 Years)
Any Pain4515
Grade 3 Pain01
Any Redness5721
Grade 3 Redness118
Any Swelling4313
Grade 3 Swelling73
SecondaryNumber of Subjects Between 6 and 10 Years of Age With Any and Grade 3 Solicited Local Symptoms

Solicited symptoms assessed were: pain, redness and swelling. Any = occurrence of any local symptom regardless of their intensity grade. Grade 3 Pain = pain that prevented normal activity. Grade 3 Redness and Swelling= redness/swelling spreading beyond (\>) 50 millimeters (mm).

Time frame:
During the 4-day (Days 0-3) post-vaccination period
Reported as:
Count of participants · Participants
Number of Subjects Between 6 and 10 Years of Age With Any and Grade 3 Solicited Local Symptoms
ParticipantsNimenrix Group (≥ 6 Years)Menjugate Group (≥ 6 Years)
Any Pain6527
Grade 3 Pain33
Any Redness5819
Grade 3 Redness95
Any Swelling4415
Grade 3 Swelling43
SecondaryNumber of Subjects Between 2 and 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms

Solicited general symptoms assessed were drowsiness, fever \[defined as oral temperature ≥ 37.5 degrees Celsius (°C)\], irritability and loss of appetite. Any = occurrence of the general symptom regardless of intensity grade and relationship to vaccination. Grade 3 Symptom = symptom that prevented normal activity. Grade 3 Loss of appetite = did not eat at all. Grade 3 Fever = fever \> 39.5°C. Related = general symptoms assessed by the investigator as causally related to vaccination

Time frame:
During the 4-day (Days 0-3) post-vaccination period
Reported as:
Count of participants · Participants
Number of Subjects Between 2 and 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms
ParticipantsNimenrix Group (< 6 Years)Menjugate Group (< 6 Years)
Any Drowsiness236
Grade 3 Drowsiness01
Related Drowsiness156
Any Fever93
Grade 3 Fever00
Related Fever93
Any Irritability256
Grade 3 Irritability11
Related Irritability165
Any Loss of appetite175
Grade 3 Loss of appetite00
Related Loss of appetite94
SecondaryNumber of Subjects Between 6 and 10 Years of Age With Any, Grade 3 and Related Solicited General Symptoms

Solicited general symptoms assessed were drowsiness, fever \[defined as oral temperature ≥ 37.5 degrees Celsius (°C)\], irritability and loss of appetite. Any = occurrence of the general symptom regardless of intensity grade and relationship to vaccination. Grade 3 Symptom = symptom that prevented normal activity. Grade 3 Loss of appetite = did not eat at all. Grade 3 Fever = fever \> 39.5°C. Related = general symptoms assessed by the investigator as causally related to vaccination

Time frame:
During the 4-day (Days 0-3) post-vaccination period
Reported as:
Count of participants · Participants
Number of Subjects Between 6 and 10 Years of Age With Any, Grade 3 and Related Solicited General Symptoms
ParticipantsNimenrix Group (≥ 6 Years)Menjugate Group (≥ 6 Years)
Any Fatigue3311
Grade 3 Fatigue40
Related Fatigue297
Any Fever (Orally)101
Grade 3 Fever (Orally)00
Related Fever (Orally)90
Any Gastrointestinal224
Grade 3 Gastrointestinal10
Related Gastrointestinal133
Any Headache304
Grade 3 Headache20
Related Headache242
SecondaryNumber of Subjects Reporting Specific Adverse Events

Specific AEs included: - rash (hives, idiopathic thrombocytopenic purpura, petechiae); - new onset of chronic illness(es) (NOCI) (e.g. autoimmune disorders, asthma, type I diabetes and allergies); - conditions prompting emergency room (ER) visits.

Time frame:
Up to 6 months after vaccination (Month 6)
Reported as:
Count of participants · Participants
Number of Subjects Reporting Specific Adverse Events
ParticipantsNimenrix GroupMenjugate Group
Any Rash(es)81
Any NOCI(s)11
Any ER visit(s)111
SecondaryNumber of Subjects With Any Unsolicited Adverse Events (AEs)

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.

Time frame:
During the 31-day (Days 0-30) post-vaccination period
Reported as:
Count of participants · Participants
Number of Subjects With Any Unsolicited Adverse Events (AEs)
ParticipantsNimenrix GroupMenjugate Group
Number of Subjects With Any Unsolicited Adverse Events (AEs)5520
SecondaryNumber of Subjects With 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:
Up to six months after vaccination (Month 6)
Reported as:
Count of participants · Participants
Number of Subjects With Any Serious Adverse Events (SAEs)
ParticipantsNimenrix GroupMenjugate Group
Number of Subjects With Any Serious Adverse Events (SAEs)61

Adverse events

Collected over Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period. Serious adverse events (SAEs): from Day 0 up to Month 6 post-vaccination.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Nimenrix Group0/311 (0%)6/311 (1.9%)181/311 (58.2%)
Menjugate Group0/103 (0%)1/103 (1%)63/103 (61.2%)
Most frequent serious events
Most frequent serious events
EventNimenrix GroupMenjugate Group
GastroenteritisInfections and infestations0/3111/103
Abdominal injuryInjury, poisoning and procedural complications1/3110/103
Accidental poisoningInjury, poisoning and procedural complications1/3110/103
Head injuryInjury, poisoning and procedural complications1/3110/103
ConvulsionNervous system disorders1/3110/103
Gastroesophageal reflux diseaseGastrointestinal disorders1/3110/103
AppendicitisInfections and infestations1/3110/103
NasopharyngitisInfections and infestations1/3110/103
Most frequent other events
Most frequent other events
EventNimenrix GroupMenjugate Group
PainGeneral disorders110/31042/103
RednessGeneral disorders115/31040/103
SwellingGeneral disorders87/31028/103
Fatigue (≥ 6 years)General disorders33/14811/50
Headache (≥ 6 years)General disorders30/1484/50
Irritability (< 6 years)General disorders25/1626/53
Gastrointestinal (≥ 6 years)General disorders22/1484/50
Drowsiness (< 6 years)General disorders23/1626/53
Loss of appetite (< 6 years)General disorders17/1625/53
FeverGeneral disorders19/3104/103

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Nimenrix GroupMenjugate GroupTotal
Mean5.6 ± 2.525.6 ± 2.325.6 ± 2.47
Sex: Female, Male
Sex: Female, Male(Participants)Nimenrix GroupMenjugate GroupTotal
Female16351214
Male14852200
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Nimenrix GroupMenjugate GroupTotal
African heritage/African American13619
Asian-Central/South Asian heritage101
Asian-East Asian heritage213
Asian-Japanese heritage101
Asian-South East Asian heritage314
White-Arabic/North African heritage16622
White-Caucasian/European heritage26787354
Not specified8210
08

Study locations

31 sites
  • GSK Investigational Site
    Draguignan, 83300, France
  • GSK Investigational Site
    Laon, 02000, France
  • GSK Investigational Site
    Le Havre, 76600, France
  • GSK Investigational Site
    Lingolsheim, 67380, France
  • GSK Investigational Site
    Miribel, 01700, France
  • GSK Investigational Site
    Nice, 06300, France
  • GSK Investigational Site
    Paris, 75015, France
  • GSK Investigational Site
    Saint Laurent du Var, 06700, France
  • GSK Investigational Site
    Tours, 37000, France
  • GSK Investigational Site
    Vaulx en Velin, 69120, France
  • GSK Investigational Site
    Vence, 06140, France
  • GSK Investigational Site
    Tettnang, Baden-Wuerttemberg 88069, Germany
  • GSK Investigational Site
    Muenchen, Bayern 81241, Germany
  • GSK Investigational Site
    Muenchen, Bayern 81735, Germany
  • GSK Investigational Site
    Noerdlingen, Bayern 86720, Germany
  • GSK Investigational Site
    Olching, Bayern 82140, Germany
  • GSK Investigational Site
    Detmold, Nordrhein-Westfalen 32756, Germany
  • GSK Investigational Site
    Espelkamp, Nordrhein-Westfalen 32339, Germany
  • GSK Investigational Site
    Goch, Nordrhein-Westfalen 47574, Germany
  • GSK Investigational Site
    Heiligenhaus, Nordrhein-Westfalen 42579, Germany
  • GSK Investigational Site
    Hille, Nordrhein-Westfalen 32479, Germany
  • GSK Investigational Site
    Porta Westfalica, Nordrhein-Westfalen 32457, Germany
  • GSK Investigational Site
    Solingen, Nordrhein-Westfalen 42719, Germany
  • GSK Investigational Site
    Velbert, Nordrhein-Westfalen 42551, Germany
  • GSK Investigational Site
    Frankenthal, Rheinland-Pfalz 67227, Germany
  • GSK Investigational Site
    Mainz, Rheinland-Pfalz 55131, Germany
  • GSK Investigational Site
    Trier, Rheinland-Pfalz 54290, Germany
  • GSK Investigational Site
    Berlin, 10315, Germany
  • GSK Investigational Site
    Berlin, 10627, Germany
  • GSK Investigational Site
    Berlin, 13055, Germany
  • GSK Investigational Site
    Berlin, 14197, Germany
09

References and documents

Publications

  • Knuf M, Romain O, Kindler K, Walther U, Tran PM, Pankow-Culot H, Fischbach T, Kieninger-Baum D, Bianco V, Baine Y, Miller J. Immunogenicity and safety of the quadrivalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine (MenACWY-TT) in 2-10-year-old children: results of an open, randomised, controlled study. Eur J Pediatr. 2013 May;172(5):601-12. doi: 10.1007/s00431-012-1924-0. Epub 2013 Jan 11. PubMed 23307281 ↗

Individual participant data

Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.

Supporting information: Study protocol, Sap, Icf, Csr

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00674583
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
May 8, 2008
Start date
May 9, 2008
Primary completion
Sep 2, 2008
Completion
Jan 8, 2009
Results posted
Oct 19, 2017
Last update
Nov 18, 2019

Study contacts

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

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