AzTrials
AzTrials

Meningococcal ImmunisationPhase 3NCT06284915

Study on Immunogenicity and Safety of a Meningococcal ACYW Conjugate Vaccine in Healthy Infants and Toddlers

A Phase 3 study testing MenACYW conjugate vaccine in people with Meningococcal Immunisation and Healthy Volunteers, run by Sanofi Pasteur, a Sanofi Company at 45 sites in 6 countries.

Completed

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

Official record

Search all trials

Trial summary

This study was conducted to support a 2-dose series (1+1 vaccination schedule) for immunization of individuals from 6 months of age. The study was designed to evaluate the non-inferiority of the immunological response of MenACYW conjugate vaccine to Nimenrix® after the completion of the 2-dose series (1+1 vaccination… Read more about this study

Who is it for?
Ages 6 to 14 monthsHealthy volunteers can take part
What is being tested?
MenACYW conjugate vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
840 participants
Where
45 sitesin 6 countries
Study dates
19 Mar 2024to 14 Nov 2025
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 14 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Aged 6 to 7 months on the day of inclusion
  • Participants who were healthy as determined by medical evaluation including medical history, physical examination and judgment of the Investigator
  • Exclusion Criteria: Participants were excluded from the study if any of the following criteria apply:
  • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid 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 study (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)
Show all 12Show fewer
  • Personal history of Guillain-Barré syndrome
  • Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine
  • Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study intervention(s) used in the study or to a product containing any of the same substances
  • Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]) on the day of study intervention administration. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
  • Receipt of any vaccine (including COVID-19) and Meningococcal B vaccines) in the 4 weeks preceding the first and second study intervention administration or planned receipt of any vaccine (including COVID-19 and Meningococcal B vaccines) in the 4 weeks following any study intervention administration except for influenza vaccination, which may be received at least 2 weeks before or 2 weeks after the study interventions. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.
  • Previous vaccination against meningococcal A, C, W, or Y disease with either the trial vaccine or another vaccine (i.e., mono- or quadrivalent meningococcal conjugate vaccine) containing serogroups A, C, Y, or W.

Who cannot join

None listed.

Trial locations and contacts

45 sites in 6 countries.

45 sites in 6 countries

Poland15 sites

  • Investigational Site Number : 6160001

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-079

  • Investigational Site Number: 6160003

    Bydgoszcz

  • Investigational Site Number: 6160008

    Bydgoszcz

  • Investigational Site Number: 6160017

    Bydgoszcz

  • Investigational Site Number: 6160015

    Krakow

  • Investigational Site Number: 6160021

    Krakow

  • Investigational Site Number: 6160016

    Łęczna

  • Investigational Site Number: 6160004

    Łomianki

  • Investigational Site Number: 6160012

    Luboń

  • Investigational Site Number: 6160011

    Siemianowice Śląskie

  • Investigational Site Number: 6160007

    Torun

  • Investigational Site Number: 6160014

    Trzebnica

  • Investigational Site Number: 6160022

    Warsaw

  • Investigational Site Number: 6160010

    Wroclav

  • Investigational Site Number: 6160002

    Wroclaw

Other trials in Poland

Germany9 sites

  • Investigational Site Number: 2760007

    Erfurt

  • Investigational Site Number: 2760004

    Herxheim

  • Investigational Site Number: 2760003

    Hürth

  • Investigational Site Number: 2760001

    Mönchengladbach

  • Investigational Site Number: 2760011

    Mönchengladbach

  • Investigational Site Number: 2760005

    Schönau am Königssee

  • Investigational Site Number: 2760008

    Schweigen-Rechtenbach

  • Investigational Site Number: 2760010

    Wolfsburg

  • Investigational Site Number : 2760009

    Worms, 67550

Other trials in Germany

Finland8 sites

  • Investigational Site Number: 2460005

    Espoo

  • Investigational Site Number: 2460002

    Helsinki

  • Investigational Site Number: 2460011

    Helsinki

  • Investigational Site Number: 2460006

    Jaarvenpa

  • Investigational Site Number : 2460003

    Kokkola, 67100

  • Investigational Site Number: 2460007

    Oulu

  • Investigational Site Number: 2460004

    Tampere

  • Investigational Site Number: 2460012

    Turku

Other trials in Finland

Denmark6 sites

  • Investigational Site Number: 2080007

    Aalborg

  • Investigational Site Number: 2080004

    Aarhus

  • Investigational Site Number: 2080006

    Herlev

  • Investigational Site Number : 2080005

    Hjørring, 9800

  • Investigational Site Number: 2080002

    Odense

  • Investigational Site Number: 2080001

    Zeeland

Other trials in Denmark

Romania4 sites

  • Investigational Site Number : 6420001

    Bucharest, 011025

  • Investigational Site Number : 6420003

    Bucharest, 021105

  • Investigational Site Number: 6420002

    Bucharest

  • Investigational Site Number: 6420005

    Calarasi

Other trials in Romania

Czechia3 sites

  • Investigational Site Number : 2030002

    České Budějovice, 370 06

  • Investigational Site Number: 2030001

    České Budějovice

  • Investigational Site Number: 2030005

    Prague

Other trials in Czechia

About this study

Official title: A Parallel-group, Prevention, Phase III, Modified Double-blind, 2-arm, Study to Investigate the Immunogenicity and Describe the Safety of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Compared With Nimenrix® When Administered in a 1+1 Schedule in Healthy Infants and Toddlers at 6 and 12 Months of Age

This study was conducted to support a 2-dose series (1+1 vaccination schedule) for immunization of individuals from 6 months of age. The study was designed to evaluate the non-inferiority of the immunological response of MenACYW conjugate vaccine to Nimenrix® after the completion of the 2-dose series (1+1 vaccination schedule), with the first dose (priming dose) being given at 6-7 months of age to MenACWY- naïve healthy infants and the second dose (booster dose) given at 12-13 months of age. This study also described additional immunogenicity parameters and safety of MenACYW conjugate vaccine and Nimenrix® in the same population of participants.

Read the detailed description

The study duration would be approximately 7 to 8.5 months (at least 7 months per participant).

Being tested
MenACYW conjugate vaccine

What participants receive

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

  • MenACYW conjugate vaccineBiological

    Also called MenQuadfi®

    Pharmaceutical form:Solution for injection (in a single-dose vial)-Route of administration:Intramuscular (IM) injection

  • MenACYW conjugate vaccineBiological

    Also called Nimenrix®

    Pharmaceutical form:Solution for injection (powder or cake in a single dose glass vial and a clear and colourless solvent in a pre filled syringe for reconstitution-Route of administration:Intramuscular (IM) injection

Study groups in NCT06284915
Study groupRoleWhat they receive
Group 1: MenACYW conjugate vaccineExperimentalParticipants received the MenACYW conjugate vaccine in a 1+1 dosing schedule (2-dose series). The priming dose (Dose 1) was administered at 6-7 months of age on Day 1, and the booster dose (Dose 2) was administered at 12-13 months of age at Month 6. Each dose consisted of 0.5 milliliter (mL) intramuscular (IM) injection.
Receives: Biological: MenACYW conjugate vaccine
Group 2: Nimenrix®Active comparatorParticipants received Nimenrix® vaccine as a 1+1 dosing schedule (2-dose series). The priming dose (Dose 1) was administered at 6-7 months of age on Day 1 and, the booster dose (Dose 2) was administered at 12-13 months of age at Month 6. Each dose consisted of 0.5 mL IM injection.
Receives: Biological: MenACYW conjugate vaccine

What is being measured

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

  1. Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y as Measured by Serum Bactericidal Assays Using Human Complement (hSBA) 30 Days After Dose 2 (Booster Dose)

    Functional meningococcal antibody activity against serogroups A, C, W, and Y was measured in a serum bactericidal assay utilizing the hSBA and the results were expressed as geometric mean titers.

    Measured: At Month 7 (30 days post-dose 2)

  2. Percentage of Participants With Vaccine Seroresponse as Measured By Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups A, C, W and Y 30 Days After Dose 2 (Booster Dose) Compared to Pre-Dose 1 (Priming Dose)

    Functional meningococcal antibody activity against serogroups A, C, W, and Y was measured in a serum bactericidal assay utilizing the hSBA. hSBA vaccine seroresponse was defined for a participant with a pre-vaccination (pre-dose 1: priming dose) titer <1:8, as a post-vaccination (post-dose 2: booster dose) titer of >=1:16 and for a participant with a pre-vaccination (pre-dose 1: priming dose) titer >=1:8, as a post-vaccination (post-dose 2: booster dose) titer that is at least 4-fold greater than the pre-vaccination (pre-dose 1: priming dose) titer. Percentages are rounded to the nearest tenth.

    Measured: Day 1 (pre-dose 1) and Month 7 (30 days post-dose 2)

Secondary outcomes (28)

  1. Percentage of Participants With Serum Bactericidal Assay Using Human Complement Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, W, and Y 30 Days After Dose 1 (Priming Dose)

    Functional meningococcal antibody activity against serogroups A, C, W, and Y was measured in a serum bactericidal assay utilizing the hSBA. The percentage of participants with antibody titers >=1:8 were assessed. Percentages are rounded to the nearest tenth.

    Measured: Day 31 (30 days post-dose 1)

  2. Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y as Measured by Serum Bactericidal Assay Using Human Complement Before Dose 1 and 30 Days After Dose 1 (Priming Dose)

    Functional meningococcal antibody activity against serogroups A, C, W, and Y was measured in a serum bactericidal assay utilizing the hSBA and the results were expressed as geometric mean titers.

    Measured: Day 1 (pre-dose 1) and Day 31 (30 days post-dose 1)

  3. Percentage of Participants With Serum Bactericidal Assay Using Human Complement Antibody Titers >=1:4 and >=1:8 Before Dose 1 (Pre-dose) and 30 Days After Dose 1 (Priming Dose)

    Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA titers >= 1:4 and >= 1:8 were analyzed. Percentages are rounded to the nearest tenth.

    Measured: Day 1 (pre-dose 1) and Day 31 (30 days post-dose 1)

  4. Percentage of Participants With >=4-Fold Rise in Serum Bactericidal Assay Using Human Complement Antibody Titers From Before Dose 1 and 30 Days After Dose 1 (Priming Dose)

    Functional meningococcal antibody activity against serogroups A, C, W, and Y was measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA titers >= 4-fold increase from baseline (pre-vaccination) were analyzed. Percentages are rounded to the nearest tenth.

    Measured: Day 1 (pre-dose 1) and Day 31 (30 days post-dose 1)

  5. Percentage of Participants With Vaccine Seroresponse as Measured by Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups A, C, W and Y 30 Days After Dose 1 Compared to Pre-Dose 1 (Priming Dose)

    Functional meningococcal antibody activity against serogroups A, C, W, and Y was measured in a serum bactericidal assay utilizing the hSBA. hSBA vaccine seroresponse was defined for a participant with a pre-vaccination (pre-dose 1: priming dose) titer <1:8, as a post-vaccination (post-dose 1: priming dose) titer of >=1:16 and for a participant with a pre-vaccination (pre-dose 1: priming dose) titer >=1:8, as a post-vaccination (post-dose 1: priming dose) titer that is at least 4-fold greater than the pre-vaccination (pre-dose 1: priming dose) titer. Percentages are rounded to the nearest tenth.

    Measured: Day 1 (pre-dose 1) and Day 31 (30 days post-dose 1)

  6. Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y as Measured by Serum Bactericidal Assay Using Human Complement Before Dose 2 and 30 Days After Dose 2 (Booster Dose)

    Functional meningococcal antibody activity against serogroups A, C, W, and Y was measured in a serum bactericidal assay utilizing the hSBA and the results were expressed as geometric mean titers.

    Measured: Month 6 (pre-dose 2) and Month 7 (30 days post-dose 2)

  7. Percentage of Participants With Serum Bactericidal Assay Using Human Complement Antibody Titers >=1:4 and >=1:8 Before Dose 2 and 30 Days After Dose 2 (Booster Dose)

    Functional meningococcal antibody activity against serogroups A, C, W, and Y was measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA titers >= 1:4 and >= 1:8 were analyzed. Percentages are rounded to the nearest tenth.

    Measured: Month 6 (pre-dose 2) and Month 7 (30 days post-dose 2)

  8. Percentage of Participants With >=4-Fold Rise in Serum Bactericidal Assay Using Human Complement Antibody Titers From Before Dose 2 and 30 Days After Dose 2 (Booster Dose)

    Functional meningococcal antibody activity against serogroups A, C, W, and Y was measured in a serum bactericidal assay that utilized hSBA. Participants with hSBA titers >= 4-fold increase from dose 2 (pre-booster dose) were analyzed. Percentages are rounded to the nearest tenth.

    Measured: Month 6 (pre-dose 2) and Month 7 (30 days post-dose 2)

  9. Percentage of Participants With Vaccine Seroresponse as Measured by Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups A, C, W, and Y 30 Days After Dose 2 Compared to Pre-Dose 2 (Booster Dose)

    Functional meningococcal antibody activity against serogroups A, C, W, and Y was measured in a serum bactericidal assay utilizing the hSBA. hSBA vaccine seroresponse was defined for a participant with a pre-vaccination (pre-dose 2: booster dose) titer <1:8, as a post-vaccination (post-dose 2: booster dose) titer of >=1:16 and for a participant with a pre-vaccination titer (pre-dose 2: booster dose) >=1:8, as a post-vaccination titer (post-dose 2: booster dose) that is at least 4-fold greater than the pre-vaccination titer (pre-dose 2: booster dose). Percentages are rounded to the nearest tenth. Percentages are rounded to the nearest tenth.

    Measured: Month 6 (pre-dose 2) and Month 7 (30 days post-dose 2)

  10. Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y as Measured by Serum Bactericidal Assay Using Human Complement Before Dose 1 (Priming Dose) and 30 Days After Dose 2 (Booster Dose)

    Functional meningococcal antibody activity against serogroups A, C, W, and Y was measured in a serum bactericidal assay utilizing the hSBA and the results were expressed as geometric mean titers.

    Measured: Day 1 (pre-dose 1) and Month 7 (30 days post-dose 2)

  11. Percentage of Participants With Serum Bactericidal Assay Using Human Complement Antibody Titers >=1:4 and >=1:8 Before Dose 1 (Priming Dose) and 30 Days After Dose 2 (Booster Dose)

    Functional meningococcal antibody activity against serogroups A, C, W, and Y was measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA titers >= 1:4 and >= 1:8 were analyzed. Percentages are rounded to the nearest tenth.

    Measured: Day 1 (pre-dose 1) and Month 7 (30 days post-dose 2)

  12. Percentage of Participants With >=4-Fold Rise in Serum Bactericidal Assay Using Human Complement Antibody Titers From Before Dose (Priming Dose) and 30 Days After Dose 2 (Booster Dose)

    Functional meningococcal antibody activity against serogroups A, C, W, and Y was measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA titers >= 4-fold increase from baseline (pre-vaccination) were analyzed. Percentages are rounded to the nearest tenth.

    Measured: Day 1 (pre-dose 1) and Month 7 (30 days post-dose 2)

  13. Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y as Measured by Serum Bactericidal Assays Using Baby Rabbit Complement (rSBA) Before Dose 1 and 30 Days After Dose 1 (Priming Dose)

    Functional meningococcal antibody activity against serogroups A, C, W, and Y was measured in a serum bactericidal assay utilizing the rSBA and the results were expressed as geometric mean titers.

    Measured: Day 1 (pre-dose 1) and Day 31 (30 days post-dose 1)

  14. Percentage of Participants With Serum Bactericidal Assays Using Baby Rabbit Complement Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, W, and Y Before Dose 1 and 30 Days After Dose 1 (Priming Dose)

    Functional meningococcal antibody activity against serogroups A, C, W, and Y was measured in a serum bactericidal assay utilizing the rSBA. Participants with rSBA titers >= 1:8 and >= 1:128 were analyzed. Percentages are rounded to the nearest tenth.

    Measured: Day 1 (pre-dose 1) and Day 31 (30 days post-dose 1)

  15. Percentage of Participants With >=4-Fold Rise in Serum Bactericidal Assays Using Baby Rabbit Complement Titers From Before Dose 1 and 30 Days After Dose 1 (Priming Dose)

    Functional meningococcal antibody activity against serogroups A, C, W, and Y was measured in a serum bactericidal assay utilizing the rSBA. Participants with rSBA titers >= 4-fold increase from baseline (pre-vaccination) were analyzed. Percentages are rounded to the nearest tenth.

    Measured: Day 1 (pre-dose 1) and Day 31 (30 days post-dose 1)

  16. Percentage of Participants With Vaccine Seroresponse as Measured by Serum Bactericidal Assays Using Baby Rabbit Complement 30 Days After Dose 1 Compared and Pre-Dose 1 (Priming Dose)

    Functional meningococcal antibody activity against serogroups A, C, W, and Y was measured in a serum bactericidal assay utilizing the rSBA. rSBA vaccine seroresponse was defined for a participant with a pre-vaccination (pre-dose 1: priming dose) titer <1:8, as a post-vaccination titer (post-dose 2: priming dose) of >=1:32 and for a participant with a pre-vaccination titer (pre-dose 1: priming dose) >=1:8, as a post-vaccination (post-dose 2: priming dose) titer that is at least 4-fold greater than the pre-vaccination (pre-dose 1: priming dose) titer. Percentages are rounded to the nearest tenth. Percentages are rounded to the nearest tenth.

    Measured: Day 1 (pre-dose 1) and Day 31 (30 days post-dose 1)

  17. Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y Measured by Serum Bactericidal Assays Using Baby Rabbit Complement Before Dose 2 and 30 Days After Dose 2 (Booster Dose)

    Functional meningococcal antibody activity against serogroups A, C, W, and Y was measured in a serum bactericidal assay utilizing the rSBA and the results were expressed as geometric mean titers.

    Measured: Month 6 (pre-dose 2) and Month 7 (30 days post-dose 2)

  18. Percentage of Participants With Serum Bactericidal Assays Using Baby Rabbit Complement Antibody Titers >=1:8 and >=1:128 Before Dose 2 and 30 Days After Dose 2 (Booster Dose)

    Functional meningococcal antibody activity against serogroups A, C, W, and Y was measured in a serum bactericidal assay utilizing the rSBA. Participants with rSBA titers >= 1:8 and >= 1:128 were analyzed. Percentages are rounded to the nearest tenth.

    Measured: Month 6 (pre-dose 2) and Month 7 (30 days post-dose 2)

  19. Percentage of Participants With >=4-Fold Rise in Serum Bactericidal Assays Using Baby Rabbit Complement Titers From Before Dose 2 and 30 Days After Dose 2 (Booster Dose)

    Functional meningococcal antibody activity against serogroups A, C, W, and Y was measured in a serum bactericidal assay utilizing the rSBA. Participants with rSBA titers >= 4-fold increase from dose 2 (pre-booster dose) were analyzed. Percentages are rounded to the nearest tenth.

    Measured: Month 6 (pre-dose 2) and Month 7 (30 days post-dose 2)

  20. Percentage of Participants With Vaccine Seroresponse as Measured by Serum Bactericidal Assays Using Baby Rabbit Complement 30 Days After Dose 2 Compared to Pre-Dose 2 (Booster Dose)

    Functional meningococcal antibody activity against serogroups A, C, W, and Y was measured in a serum bactericidal assay utilizing the rSBA. rSBA vaccine seroresponse was defined for a participant with a pre-vaccination (pre-dose 2: booster dose) titer <1:8 as a post-vaccination (post-dose 2: booster dose) titer of >=1:32 and for a participant with a pre-vaccination (pre-dose 2: booster dose) titer >=1:8 as a post-vaccination (post-dose 2: booster dose) titer that is at least 4-fold greater than the pre-vaccination (pre-dose 2: booster dose) titer. Percentages are rounded to the nearest tenth.

    Measured: Month 6 (pre-dose 2) and Month 7 (30 days post-dose 2)

  21. Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y Measured by Serum Bactericidal Assays Using Baby Rabbit Complement Before Dose 1 (Priming Dose) and 30 Days After Dose 2 (Booster Dose)

    Functional meningococcal antibody activity against serogroups A, C, W, and Y was measured in a serum bactericidal assay utilizing the rSBA and the results were expressed as geometric mean titers.

    Measured: Day 1 (pre-dose 1) and Month 7 (30 days post-dose 2)

  22. Percentage of Participants With Serum Bactericidal Assays Using Baby Rabbit Complement Antibody Titers >=1:8 and >=1:128 Before Dose 1 (Priming Dose) and 30 Days After Dose 2 (Booster Dose)

    Functional meningococcal antibody activity against serogroups A, C, W, and Y was measured in a serum bactericidal assay utilizing the rSBA. Participants with rSBA titers >= 1:8 and >= 1:128 were analyzed. Percentages are rounded to the nearest tenth.

    Measured: Day 1 (pre-dose 1) and Month 7 (30 days post-dose 2)

  23. Percentage of Participants With >=4-Fold Rise in Serum Bactericidal Assays Using Baby Rabbit Complement Titers From Before Dose (Priming Dose) and 30 Days After Dose 2 (Booster Dose)

    Functional meningococcal antibody activity against serogroups A, C, W, and Y was measured in a serum bactericidal assay utilizing the rSBA. Participants with rSBA titers >= 4-fold increase from baseline (pre-vaccination) were analyzed. Percentages are rounded to the nearest tenth.

    Measured: Day 1 (pre-dose 1) and Month 7 (30 days post-dose 2)

  24. Percentage of Participants With Vaccine Seroresponse as Measured by Serum Bactericidal Assays Using Baby Rabbit Complement 30 Days After Dose 2 (Booster Dose) Compared to Pre-Dose 1 (Priming Dose)

    Functional meningococcal antibody activity against serogroups A, C, W, and Y was measured in a serum bactericidal assay utilizing the rSBA. rSBA vaccine seroresponse was defined for a participant with a pre-vaccination (pre-dose 1: priming dose) titer <1:8, as a post-vaccination (post-dose 2: booster dose) titer of >=1:32 and for a participant with a pre-vaccination (pre-dose 1: priming dose) titer >=1:8, as a post-vaccination (post-dose 2: booster dose) titer that is at least 4-fold greater than the pre-vaccination (pre-dose 1: priming dose) titer. Percentages are rounded to the nearest tenth.

    Measured: Day 1 (pre-dose 1) and Month 7 (30 days post-dose 2)

  25. Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)

    An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the case report form (CRF) in terms of diagnosis and onset window post-vaccination.

    Measured: Up to 30 minutes after each vaccination (Dose 1 on Day 1 and Dose 2 on Month 6)

  26. Number of Participants With Solicited Injection Site Reactions and Systemic Reactions

    A solicited reaction was an "expected" adverse reaction (AR) (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF. An injection site reaction was an AR at and around the injection site. Solicited systemic reactions were systemic AEs observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF.

    Measured: Up to 7 days after each vaccination (Dose 1 on Day 1 and Dose 2 on Month 6)

  27. Number of Participants With Unsolicited Adverse Events

    An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the CRF in terms of diagnosis and/or onset window post-vaccination.

    Measured: Up to 30 days after each vaccination (Dose 1 on Day 1 and Dose 2 on Month 6)

  28. Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)

    An SAE was any AE 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, or was an important medical event. An AESI (serious or non-serious) was defined as one of scientific and medical concern specific to the Sponsor's study intervention or program, for which ongoing monitoring and rapid communication by the investigator to the Sponsor could be appropriate.

    Measured: From first vaccination (Day 1) up to 30 days post last vaccination, approximately 7 months

Timeline

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

  1. First posted29 Feb 2024
  2. Study start19 Mar 2024
  3. Primary completion14 Nov 2025
  4. Study completion14 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
840 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06284915
Sponsor's protocol ID
MEQ00089
Other IDs
2023-508177-85, U1111-1280-6981, 2023-508177-85, 2023
Status last verified
Aug 2026
First submitted
22 Feb 2024
Last updated
7 Oct 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in