ClinicalTrials.gg
CompletedNCT03476135Updated Apr 6, 2022Results posted

Immunogenicity and Safety of a Booster Dose of a Quadrivalent Meningococcal Conjugate Vaccine in Children

A Phase 3 interventional study of MenACYW conjugate vaccine in Meningococcal Infections, sponsored by Sanofi Pasteur, a Sanofi Company. Completed at 8 sites in Finland. Open to participants aged 46 Months to 61 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-06.

Sponsored by Sanofi Pasteur, a Sanofi Company (part of Sanofi) · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
91
Allocation
Non-randomized
Ages
46 Months to 61 Months
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 53 studies in Meningococcal Infections by Sanofi Pasteur, a Sanofi Company — 1 open to participants now, 1 under way, none of them phase 3. Meningococcal Infections · Sanofi Pasteur, a Sanofi Company.

Enrollment
45th of 47
91 · median 378
Started
2018
with 6 others
Phase 3
22 of 53
none open now
Registered
43rd of 53
by date

Among the 53 studies in Meningococcal Infections by Sanofi Pasteur, a Sanofi Company, this one is the 45th largest by enrollment of the 47 interventional ones, is one of 7 that started in 2018, is one of 22 in phase 3, and was the 43rd registered.

By phase

53 studies; the count open now beside each. This study's row is marked.

Phase 3this study22 · 0 open
Phase 215 · 0 open
Phase 48 · 0 open
Observational6 · 1 open
Phase 11 · 0 open
Phase 1/21 · 0 open

By the year they started

First in 2002; this study’s year is marked. 7 started in 2018.

Size and results

Median enrollment 378 across the 47 interventional studies, 440 across the 6 observational. Of the 52 that completed or were terminated, 49 (94%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 53 studies in Meningococcal Infections by Sanofi Pasteur, a Sanofi Company, or all of them as a file.
02

Study summary

This was an open-label, multi-center study to describe the immune persistence of the priming dose and describe the immunogenicity and safety of a booster dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid (MenACYW) conjugate vaccine in children in Finland who had been vaccinated 3 years earlier as toddlers with either MenACYW conjugate vaccine or Nimenrix® as part of the MET54 study (NCT03205358).

The objectives were:

  • To describe the antibody persistence of meningococcal serogroups A, C, Y, and W before a booster dose in children who received either MenACYW conjugate vaccine or Nimenrix® 3 years earlier as toddlers.
  • To describe the antibody responses to meningococcal serogroups A, C, Y, and W 30 days after a booster dose of MenACYW conjugate vaccine in children who received either MenACYW conjugate vaccine or Nimenrix® 3 years earlier as toddlers.
  • To describe the antibody responses against tetanus toxoid 30 days after a booster dose of MenACYW conjugate vaccine in children who received either MenACYW conjugate vaccine or Nimenrix® 3 years earlier as toddlers.
  • To describe the safety profile of a booster dose of MenACYW conjugate vaccine in children who received either MenACYW conjugate vaccine or Nimenrix® 3 years earlier as toddlers.
Read the detailed description

Healthy children who were vaccinated 3 years earlier at 12 to 23 months of age in study MET54 (NCT03205358) were eligible for enrollment. All participants received a single booster dose of MenACYW conjugate vaccine on Day 0. Immunogenicity was assessed at pre-vaccination and 30 days after vaccination. Safety was assessed throughout the study period, and included solicited injection site and systemic reactions (Day 0 to Day 7 post-vaccination); unsolicited adverse events up to Day 30 (Visit 2), and serious adverse events occurring throughout the trial.

03

Conditions studied

  • Meningococcal Infections

Keywords

  • Meningococcal Meningitis
  • MenACYW conjugate vaccine
  • Quadrivalent meningococcal vaccine
04

Who can participate

Ages eligible
46 Months to 61 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participated in and completed (attended Visit 2) study MET54.
  • form had been signed and dated by the parent(s) or another legally acceptable representative (and by an independent witness, if required by local regulations).
  • Participant and parent/legally acceptable representative were able to attend all scheduled visits and complied with all trial procedures.
  • Covered by health insurance where applicable.

Exclusion criteria

Exclusion Criteria:

  • Participation in the 4 weeks preceding the trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
  • Receipt of any vaccine in the 4 weeks (28 days) preceding the trial vaccination or planned receipt of any vaccine prior to Visit 2 except for influenza vaccination, which might be received at a gap of at least 2 weeks before or after the study vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines. If the participant was due to receive vaccination(s) recommended for his/her age by the national immunization schedule at the time of the study, the participant was recommended to complete his/her immunization schedule after Visit 2.
  • Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (i.e., mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal B vaccine) with the exception of the single dose of meningococcal vaccine administered as part of study MET54.
  • Receipt of immune globulins, blood or blood-derived products in the past 3 months.
  • Known or suspected congenital or acquired immunodeficiency; or receipt of therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
  • History of meningococcal infection, confirmed either clinically, serologically, or microbiologically
  • At high risk for meningococcal infection during the trial (specifically, but not limited to, participants with persistent complement deficiency, with anatomic or functional asplenia, or participants traveling to countries with high endemic or epidemic disease).
  • Known systemic to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances.
  • Verbal report of thrombocytopenia, contraindicating intramuscular vaccination in the Investigator's opinion.
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination.
  • Personal history of Guillain-Barré syndrome.
  • Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine.
  • Chronic illness that, in the opinion of the Investigator, was at a stage where it might interfere with trial conduct or completion.
  • Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature >= 38.0 degree Celsius [°C]). A prospective participant was not included in the study until the condition had resolved or the febrile event had subsided.
  • Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw.
  • Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
91 participants (actual)

Study arms

  • Experimental
    Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)

    Participants who received a single dose of MenACYW conjugate vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).

    Biological: MenACYW conjugate vaccine

  • Experimental
    Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)

    Participants who received a single dose of Nimenrix® vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).

    Biological: MenACYW conjugate vaccine

Interventions

  • BiologicalMenACYW conjugate vaccine

    Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine 0.5 mL, intramuscular

06

What researchers measure

Primary outcomes

  1. Antibody Titers Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W Before a Booster Dose of MenACYW Conjugate Vaccine in MET62

    Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA.

    Time frame: Day 0 (pre-vaccination)

  2. Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After a Booster Dose of MenACYW Conjugate Vaccine in MET62

    Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA.

    Time frame: Day 30 (post-booster vaccination)

  3. Antibody Titers Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W Before a Booster Dose of MenACYW Conjugate Vaccine in MET62

    Antibody titers against meningococcal serogroups A, C, Y, and W were measured by rSBA.

    Time frame: Day 0 (pre-vaccination)

  4. Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After a Booster Dose of MenACYW Conjugate Vaccine in MET62

    Antibody titers against meningococcal serogroups A, C, Y, and W were measured by rSBA.

    Time frame: Day 30 (post-booster vaccination)

  5. Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62

    Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA.

    Time frame: Day 0 (pre-vaccination) and Day 30 (post-priming vaccination) in study MET54, and Day 0 (pre-vaccination) and Day 30 (post-booster vaccination) in study MET62

  6. Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62

    Antibody titers against meningococcal serogroups A, C, Y, and W were measured by rSBA.

    Time frame: Day 0 (pre-vaccination) and Day 30 (post-priming vaccination) in study MET54, and Day 0 (pre-vaccination) and Day 30 (post-booster vaccination) in study MET62

  7. Antibody Concentrations Against Tetanus Toxoid Before a Booster Dose of MenACYW Conjugate Vaccine in MET62

    Anti-tetanus antibodies were measured by electrochemiluminescent (ECL) assay.

    Time frame: Day 0 (pre-vaccination)

  8. Antibody Concentrations Against Tetanus Toxoid After a Booster Dose of MenACYW Conjugate Vaccine in MET62

    Anti-tetanus antibodies were measured by ECL assay.

    Time frame: Day 30 (post-booster vaccination)

  9. Number of Participants With Immediate Adverse Event After Vaccination in MET62

    Immediate events captured medically relevant unsolicited systemic adverse events (AEs) that occurred within the first 30 minutes after vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. Systemic AEs were all AEs that were not injection or administration site reactions.

    Time frame: Within 30 minutes after vaccination

  10. Number of Participants With Solicited Injection Site Reactions and Systemic Reactions in MET62

    A solicited reaction (SR) was an adverse reaction (AR) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB. Solicited injection site reactions: pain, erythema, and swelling. Solicited systemic reactions: fever, headache, malaise and, myalgia.

    Time frame: Within 7 days after vaccination

  11. Number of Participants With Unsolicited Adverse Event After Vaccination in MET62

    An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRB in terms of diagnosis and/or onset window post-vaccination.

    Time frame: Within 30 days after vaccination

  12. Number of Participants With a Serious Adverse Event (SAE) After Vaccination in MET62

    A SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was an important medical event.

    Time frame: Within 30 days after vaccination

07

Results

Posted Jun 5, 2020

Participant flow

The study was conducted at 8 sites in Finland from 27 February 2018 to 10 September 2018.

Participant flow — Overall Study
MilestoneGroup 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)
Started4249
Completed4249
Not completed00

Outcome measures

PrimaryAntibody Titers Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W Before a Booster Dose of MenACYW Conjugate Vaccine in MET62

Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA.

Time frame:
Day 0 (pre-vaccination)
Reported as:
Geometric mean · titers (1/dilution)
Antibody Titers Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W Before a Booster Dose of MenACYW Conjugate Vaccine in MET62
titers (1/dilution)Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)
Serogroup A12.1 (8.15 to 18.1)16.5 (11.9 to 22.9)
Serogroup C106 (73.2 to 153)11.7 (7.03 to 19.4)
Serogroup Y30.9 (24.2 to 39.5)17.6 (13.1 to 23.7)
Serogroup W48.5 (34.4 to 68.4)21.9 (14.7 to 32.7)
PrimaryAntibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After a Booster Dose of MenACYW Conjugate Vaccine in MET62

Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA.

Time frame:
Day 30 (post-booster vaccination)
Reported as:
Geometric mean · titers (1/dilution)
Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After a Booster Dose of MenACYW Conjugate Vaccine in MET62
titers (1/dilution)Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)
Serogroup A763 (521 to 1117)659 (427 to 1017)
Serogroup C5894 (4325 to 8031)1592 (1165 to 2174)
Serogroup Y2013 (1451 to 2792)2806 (2066 to 3813)
Serogroup W2656 (1601 to 4406)3444 (2387 to 4970)
PrimaryAntibody Titers Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W Before a Booster Dose of MenACYW Conjugate Vaccine in MET62

Antibody titers against meningococcal serogroups A, C, Y, and W were measured by rSBA.

Time frame:
Day 0 (pre-vaccination)
Reported as:
Geometric mean · titers (1/dilution)
Antibody Titers Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W Before a Booster Dose of MenACYW Conjugate Vaccine in MET62
titers (1/dilution)Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)
Serogroup A135 (58.0 to 314)281 (131 to 606)
Serogroup C102 (60.9 to 169)11.9 (6.14 to 22.9)
Serogroup Y119 (65.0 to 219)126 (69.1 to 230)
Serogroup W113 (54.6 to 234)126 (63.6 to 250)
PrimaryAntibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After a Booster Dose of MenACYW Conjugate Vaccine in MET62

Antibody titers against meningococcal serogroups A, C, Y, and W were measured by rSBA.

Time frame:
Day 30 (post-booster vaccination)
Reported as:
Geometric mean · titers (1/dilution)
Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After a Booster Dose of MenACYW Conjugate Vaccine in MET62
titers (1/dilution)Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)
Serogroup A4240 (3352 to 5365)5702 (4575 to 7107)
Serogroup C8629 (6573 to 11328)4871 (3750 to 6327)
Serogroup Y5499 (4502 to 6717)7814 (6465 to 9445)
Serogroup W16103 (12691 to 20431)19793 (15538 to 25214)
PrimaryAntibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62

Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA.

Time frame:
Day 0 (pre-vaccination) and Day 30 (post-priming vaccination) in study MET54, and Day 0 (pre-vaccination) and Day 30 (post-booster vaccination) in study MET62
Reported as:
Geometric mean · titers (1/dilution)
Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62
titers (1/dilution)Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)
Serogroup A: Day 0 (MET54)3.68 (3.12 to 4.33)3.67 (3.15 to 4.29)
Serogroup A: Day 30 (MET54)83.3 (63.9 to 109)49.6 (32.1 to 76.7)
Serogroup A: Day 0 (MET62)11.9 (8.11 to 17.4)14.7 (10.7 to 20.2)
Serogroup A: Day 30 (MET62)755 (520 to 1097)629 (418 to 948)
Serogroup C: Day 0 (MET54)2.48 (2.04 to 3.01)2.30 (2.12 to 2.50)
Serogroup C: Day 30 (MET54)594 (445 to 793)29.4 (20.1 to 43.1)
Serogroup C: Day 0 (MET62)103 (71.7 to 149)11.6 (7.28 to 18.3)
Serogroup C: Day 30 (MET62)5744 (4230 to 7800)1618 (1204 to 2172)
Serogroup Y: Day 0 (MET54)2.17 (1.95 to 2.42)2.27 (2.05 to 2.52)
Serogroup Y: Day 30 (MET54)105 (73.9 to 149)75.8 (54.2 to 106)
Serogroup Y: Day 0 (MET62)32.5 (24.8 to 42.7)18.2 (13.8 to 24.0)
Serogroup Y: Day 30 (MET62)2048 (1486 to 2823)2710 (2022 to 3633)
Serogroup W: Day 0 (MET54)2.00 (NA to NA)2.12 (2.00 to 2.24)
Serogroup W: Day 30 (MET54)71.8 (53.3 to 96.7)40.1 (30.6 to 52.6)
Serogroup W: Day 0 (MET62)50.0 (35.9 to 69.5)21.2 (14.6 to 30.9)
Serogroup W: Day 30 (MET62)2776 (1682 to 4584)3235 (2278 to 4594)
PrimaryAntibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62

Antibody titers against meningococcal serogroups A, C, Y, and W were measured by rSBA.

Time frame:
Day 0 (pre-vaccination) and Day 30 (post-priming vaccination) in study MET54, and Day 0 (pre-vaccination) and Day 30 (post-booster vaccination) in study MET62
Reported as:
Geometric mean · titers (1/dilution)
Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62
titers (1/dilution)Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)
Serogroup A: Day 0 (MET54)12.3 (5.25 to 28.8)4.88 (2.74 to 8.69)
Serogroup A: Day 30 (MET54)3198 (2559 to 3996)7633 (5879 to 9909)
Serogroup A: Day 0 (MET62)124 (54.0 to 283)239 (113 to 503)
Serogroup A: Day 30 (MET62)4096 (3223 to 5205)5341 (4275 to 6674)
Serogroup C: Day 0 (MET54)2.21 (1.81 to 2.70)2.15 (1.86 to 2.47)
Serogroup C: Day 30 (MET54)2711 (2156 to 3409)414 (283 to 607)
Serogroup C: Day 0 (MET62)94.4 (55.9 to 160)11.2 (6.11 to 20.6)
Serogroup C: Day 30 (MET62)8474 (6483 to 11075)4817 (3759 to 6175)
Serogroup Y: Day 0 (MET54)2.88 (1.87 to 4.42)4.29 (2.48 to 7.44)
Serogroup Y: Day 30 (MET54)2667 (2063 to 3447)2836 (2127 to 3781)
Serogroup Y: Day 0 (MET62)120 (67.1 to 213)123 (67.6 to 223)
Serogroup Y: Day 30 (MET62)5553 (4565 to 6755)7498 (6213 to 9049)
Serogroup W: Day 0 (MET54)2.00 (NA to NA)2.24 (1.78 to 2.81)
Serogroup W: Day 30 (MET54)5793 (4346 to 7720)4214 (3162 to 5616)
Serogroup W: Day 0 (MET62)106 (51.6 to 219)113 (57.9 to 219)
Serogroup W: Day 30 (MET62)15839 (12530 to 20023)18710 (14737 to 23753)
PrimaryAntibody Concentrations Against Tetanus Toxoid Before a Booster Dose of MenACYW Conjugate Vaccine in MET62

Anti-tetanus antibodies were measured by electrochemiluminescent (ECL) assay.

Time frame:
Day 0 (pre-vaccination)
Reported as:
Geometric mean · International unit per milliliter(IU/mL)
Antibody Concentrations Against Tetanus Toxoid Before a Booster Dose of MenACYW Conjugate Vaccine in MET62
International unit per milliliter(IU/mL)Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)
Antibody Concentrations Against Tetanus Toxoid Before a Booster Dose of MenACYW Conjugate Vaccine in MET623.12 (2.05 to 4.75)3.02 (2.11 to 4.31)
PrimaryAntibody Concentrations Against Tetanus Toxoid After a Booster Dose of MenACYW Conjugate Vaccine in MET62

Anti-tetanus antibodies were measured by ECL assay.

Time frame:
Day 30 (post-booster vaccination)
Reported as:
Geometric mean · IU/mL
Antibody Concentrations Against Tetanus Toxoid After a Booster Dose of MenACYW Conjugate Vaccine in MET62
IU/mLGroup 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)
Antibody Concentrations Against Tetanus Toxoid After a Booster Dose of MenACYW Conjugate Vaccine in MET6210.4 (8.41 to 12.8)9.36 (7.61 to 11.5)
PrimaryNumber of Participants With Immediate Adverse Event After Vaccination in MET62

Immediate events captured medically relevant unsolicited systemic adverse events (AEs) that occurred within the first 30 minutes after vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. Systemic AEs were all AEs that were not injection or administration site reactions.

Time frame:
Within 30 minutes after vaccination
Reported as:
Count of participants · Participants
Number of Participants With Immediate Adverse Event After Vaccination in MET62
ParticipantsGroup 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)
Number of Participants With Immediate Adverse Event After Vaccination in MET6200
PrimaryNumber of Participants With Solicited Injection Site Reactions and Systemic Reactions in MET62

A solicited reaction (SR) was an adverse reaction (AR) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB. Solicited injection site reactions: pain, erythema, and swelling. Solicited systemic reactions: fever, headache, malaise and, myalgia.

Time frame:
Within 7 days after vaccination
Reported as:
Count of participants · Participants
Number of Participants With Solicited Injection Site Reactions and Systemic Reactions in MET62
ParticipantsGroup 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)
Pain2635
Erythema2227
Swelling1619
Fever34
Headache814
Malaise1315
Myalgia1421
PrimaryNumber of Participants With Unsolicited Adverse Event After Vaccination in MET62

An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRB in terms of diagnosis and/or onset window post-vaccination.

Time frame:
Within 30 days after vaccination
Reported as:
Count of participants · Participants
Number of Participants With Unsolicited Adverse Event After Vaccination in MET62
ParticipantsGroup 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)
Number of Participants With Unsolicited Adverse Event After Vaccination in MET622215
PrimaryNumber of Participants With a Serious Adverse Event (SAE) After Vaccination in MET62

A SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was an important medical event.

Time frame:
Within 30 days after vaccination
Reported as:
Count of participants · Participants
Number of Participants With a Serious Adverse Event (SAE) After Vaccination in MET62
ParticipantsGroup 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)
Number of Participants With a Serious Adverse Event (SAE) After Vaccination in MET6200

Adverse events

Collected over SR were collected up to Day 7 after each vaccination, non-serious unsolicited AEs were collected up to Day 30 after each vaccination. SAEs were collected throughout the trial (up to 30 days after vaccination).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)0/42 (0%)0/42 (0%)36/42 (85.7%)
Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)0/49 (0%)0/49 (0%)43/49 (87.8%)
Most frequent other events
Most frequent other events
EventGroup 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)
Injection Site PainGeneral disorders26/4235/49
Injection Site ErythemaGeneral disorders22/4227/49
MyalgiaMusculoskeletal and connective tissue disorders14/4221/49
Injection Site SwellingGeneral disorders16/4219/49
MalaiseGeneral disorders13/4215/49
HeadacheNervous system disorders10/4214/49
Upper Respiratory Tract InfectionInfections and infestations7/424/49
PyrexiaGeneral disorders3/424/49
Otitis MediaInfections and infestations1/423/49

Baseline characteristics

Analysis was performed on all enrolled participants.

Age, Continuous
Age, Continuous(years)Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)Total
Mean3.9 ± 0.353.9 ± 0.333.9 ± 0.34
Sex: Female, Male
Sex: Female, Male(Participants)Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)Total
Female163046
Male261945
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)Total
Count of participants——0
08

Study locations

8 sites
  • Sanofi Pasteur Investigational Site 2460005
    Espoo, 02230, Finland
  • Sanofi Pasteur Investigational Site 2460006
    Helsinki, 00100, Finland
  • Sanofi Pasteur Investigational Site 2460002
    Helsinki, 00930, Finland
  • Sanofi Pasteur Investigational Site 2460007
    Järvenpää, 04400, Finland
  • Sanofi Pasteur Investigational Site 2460008
    Oulu, 90220, Finland
  • Sanofi Pasteur Investigational Site 2460001
    Pori, 28100, Finland
  • Sanofi Pasteur Investigational Site 2460003
    Tampere, 33100, Finland
  • Sanofi Pasteur Investigational Site 2460004
    Turku, 20520, Finland
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2018 to primary completion in Sep 2018, 6 months.

Results were first posted in Jun 2020, 1 year 8 months after primary completion. A results delay was requested in Sep 2019.

Of 46 industry-sponsored phase 3 interventional studies under Meningococcal Infections, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 40. This study's 6 months is below that.

Counting every sponsor, half of 46 studies reached it within 15 months; a quarter within 8 and three quarters within 40.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 19, 2018
First posted
Mar 23, 2018
StartActual
Feb 27, 2018
Primary completionActual
Sep 10, 2018
CompletionActual
Sep 10, 2018
Results delay requested
Sep 5, 2019
Results first posted
Jun 5, 2020
Last update
Apr 6, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 6, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03476135
Responsible party
Sponsor
First posted
Mar 23, 2018
Start date
Feb 27, 2018
Primary completion
Sep 10, 2018
Completion
Sep 10, 2018
Results posted
Jun 5, 2020
Last update
Apr 6, 2022

Study contacts

Medical Director
study director · Sanofi Pasteur, a Sanofi Company

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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