Safety and Immunogenicity of an Investigational Pentavalent Meningococcal ABCYW Vaccine Against Meningococcal Disease in Children, Toddlers, and Infants

NCT06647407
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Phase
Phase 1/Phase 2
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Recruitment status
Active, not recruiting
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Participants
750
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Lead sponsor
Sanofi Pasteur, a Sanofi Company
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Start date
2024-11-05
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Number of sites
39
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Summary
This study is the first study of Sanofi's Pentavalent Meningococcal ABCYW vaccine clinical development program to be conducted in the pediatric population below 10 years of age. The aim of the study is to assess 2 formulations of the MenPenta vaccine compared to licensed meningococcal vaccines when administered alone in children (Stage 1) or concomitantly with routine pediatric vaccines in toddlers (Stage 2) and infants (Stage 3). Study details include: The study duration per participant will be up to 12 months for children in Stage 1 and toddlers in Stage 2 and 16 to-19 months for infants in Stage 3.
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Short title
Safety and Immunogenicity of an Investigational Pentavalent Meningococcal ABCYW Vaccine Against Meningococcal Disease in Children, Toddlers, and Infants
clinicaltrials.gov
Official title
A Parallel-group Prevention, Phase II, Partially Blinded, Multi-stage Study to Investigate the Immunogenicity and Safety of Pentavalent Meningococcal ABCYW Vaccine Formulations Compared With Licensed Meningococcal Vaccines When Administered Alone in Healthy Children (2 to 9 Years of Age) or Concomitantly With Routine Pediatric Vaccines in Toddlers (12 to 15 Months of Age) and Infants (2 Months of Age).
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 1/Phase 2
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Study type
Interventional
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Completion date
2027-05-17
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First posted
2024-10-17
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Registry last updated
2026-01-20
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Primary completion date
2027-05-17
clinicaltrials.gov
Start date
2024-11-05
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Participants
750
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Participant count basis
Estimated
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Planned participants
750
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Protocol amendments
0
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Number of sites
39
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Sanofi Pasteur, a Sanofi Company
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06647407
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ClinicalTrials.gov ID
NCT06647407
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
Quadruple masking
Masking description
Partially blinded (treatment assignment is blinded between the two investigational formulation groups, and open label between the investigation and the comparator group) * Laboratory personnel will be blinded to the treatment assignment * Participants, Investigators, and Site staff preparing and administering the study intervention will be unblinded between the MenPenta and comparator groups but will be blinded between the 2 MenPenta groups The Sponsor will be partially blinded. At the time of periodic data reviews, additional measures are put in place to maintain the blind of the study participants for the Sponsor staff. The data review will be conducted on the basis of blinded outputs (where data of the 2 MenPenta groups and the control group will be reviewed in aggregate, without any distinction by group). By design, the Sponsor team will have access to partially blinded data for individual participants (eg, for assessment of SAE)
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Number of participants with unsolicited immediate adverse events (AEs)

    Timeframe: Within 30 minutes after each vaccination

    Unsolicited systemic AEs that occur within 30 minutes after vaccination

  2. Number of participants with solicited injection site reactions or systemic reactions

    Timeframe: Within 7 days after each vaccination

    Pre-defined solicited injection site reactions and systemic reactions that are pre-listed in the diary cards and CRF

  3. Number of participants with unsolicited AEs

    Timeframe: Within 30 days after each vaccination

    Unsolicited AEs other than solicited reactions

  4. Number of participants with serious adverse events (SAEs)

    Timeframe: Throughout the study, from first visit until 180 days after the last vaccination

    SAEs (including adverse events of special interest \[AESIs\]) reported throughout the study

  5. hSBA meningococcal serogroups A, C, W, and Y antibody titers pre-dose and 30 days after the second and third dose in infant participants

    Timeframe: For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391

    hSBA titers ≥ 1:8 post-vaccination (post-second and third dose)

  6. hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse pre-dose and 1 month after the second and third dose in infant participants

    Timeframe: For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391

    Seroresponse defined as post-vaccination titers ≥ 1:16 for participants with pre-vaccination hSBA titers \< 1:4 or or postvaccination titers ≥ 4 times the lower limit of quantification (LLOQ) for participants with a pre-vaccination titer ≤ LLOQ or a post-vaccination titer ≥ 4 times the pre-vaccination titer for participants with a pre-vaccination titer ≥ LLOQ

  7. Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroups A, C, W and Y pre-dose and 1 month after the second and third dose in infant participants

    Timeframe: For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391

    Geometric mean titers (pre-dose and post-second and third dose)

  8. Percentage of participants with hSBA titers more or equal to lower limit of quantification (LLOQ) against each of serogroups A, C, W, and Y pre-dose and 1 month after the second and third dose in infant participants

    Timeframe: For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391

  9. Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:4 pre-dose and 1 month after second dose of vaccination against serogroup B, before and 30 days after third dose in infants

    Timeframe: For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391

    hSBA titers ≥ 1:4 for reference MenB strains

  10. Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:8 pre-dose and 1 month after the second dose of vaccination against serogroup B, before and 30 days after third dose in infants

    Timeframe: For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391

    hSBA titers ≥ 1:8 for reference MenB strains

  11. hSBA meningococcal serogroup B seroresponse pre-dose and 1 month after the second dose of vaccination against serogroup B, before and 30 days after third dose in infant participants

    Timeframe: For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391

    Seroresponse defined as a 4-fold increase in hSBA titers

  12. Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (reference MenB strains) pre-dose and 1 month after the second dose of vaccination against serogroup B, before and 30 days after third dose in infant participants

    Timeframe: Day 01, Day 91, Day 181 and Day 211 (for Stage 3)

    Geometric mean titers (pre-dose and post-second dose) for the reference MenB strains

  13. Percentage of participants with hSBA titers more or equal to lower limit of quantification (LLOQ) against each and all of serogroup B (ref. MenB strains) predose and 1 month after 2nd dose against serogroup B, before and 30 days after 3rd dose in infants

    Timeframe: For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391

  14. Percentage of participants with hSBA titers less than LLOQ against all serogroup B (ref. MenB strains) pre-dose and 1 month after the 2nd dose of vaccination against serogroup B, before and 30 days after 3rd dose in infants

    Timeframe: For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391

  15. hSBA meningococcal serogroups A, C, W, and Y antibody titers in children and toddlers

    Timeframe: For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211

    hSBA titers ≥ 1:8 for serogroups A, C, W, and Y

  16. hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse in children and toddlers

    Timeframe: For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211

    Seroresponse defined as post-vaccination titers ≥ 1:16 for participants with pre-vaccination hSBA titers \< 1:4 or or postvaccination titers ≥ 4 times the lower limit of quantification (LLOQ) for participants with a pre-vaccination titer ≤ LLOQ or a post-vaccination titer ≥ 4 times the pre-vaccination titer for participants with a pre-vaccination titer ≥ LLOQ

  17. Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroups A, C, W and Y pre-dose and 1 month after the second dose children and toddlers

    Timeframe: For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211

  18. Percentage of participants with hSBA titers more or equal to lower limit of quantification (LLOQ) against each of serogroups A, C, W, and Y children and toddlers

    Timeframe: For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211

  19. Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:4 in children and toddlers

    Timeframe: For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211

  20. Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:8 in children and toddlers

    Timeframe: For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211

  21. hSBA meningococcal serogroup B (reference MenB strains) vaccine seroresponse in children and toddlers

    Timeframe: For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211

    Seroresponse defined as a 4-fold increase in hSBA titers

  22. Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (reference MenB strains) in children and toddlers

    Timeframe: For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211

  23. Percentage of participants with hSBA titers more or equal to lower limit of quantification (LLOQ) against each and all of serogroup B (reference MenB strains) in children and toddlers

    Timeframe: For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211

  24. Percentage of participants with hSBA titers less than the lower limit of quantification (LLOQ) against all serogroup B (reference MenB strains) in children and toddlers

    Timeframe: For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211

  1. hSBA meningococcal serogroup B (additional MenB strains) vaccine seroresponse in children, toddler and infant participants

    Timeframe: Stage 1 and 2: Day 1 and Day 211. Stage 3: Day 1, Day 331-391

  2. Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (additional MenB strains) ≥ 1:4 in children, toddler and infant participants

    Timeframe: Stage 1 and 2: Day 1 and Day 211. Stage 3: Day 1, Day 331-391

    hSBA titers ≥ 1:4 for additional MenB strains

  3. Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (additional MenB strains) ≥ 1:8 in children, toddler and infant participants

    Timeframe: Stage 1 and 2: Day 1 and Day 211. Stage 3: Day 1, Day 331-391

    hSBA titers ≥ 1:8 for additional MenB strains

  4. Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (additional MenB strains) in children, toddler and infant participants

    Timeframe: Stage 1 and 2: Day 1 and Day 211. Stage 3: Day 1, Day 331-391

  5. Percentage of participants with hSBA composite seroresponse titers more or equal to LLOQ each and all additional MenB strains in children, toddler and infant participants

    Timeframe: Stage 1 and 2: Day 1 and Day 211. Stage 3: Day 1, Day 331-391

  6. Percentage of participants with hSBA composite seroresponse titers less than LLOQ all additional MenB strains in children, toddler and infant participants

    Timeframe: Stage 1 and 2: Day 1 and Day 211. Stage 3: Day 1, Day 331-391

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Children
Minimum age
56 Days
Maximum age
9 Years
Healthy volunteers
Yes

  • Aged 2 to 9 years (Stage 1) or 12 to 15 months (Stage 2) or 56 to 89 days (Stage 3) on the day of inclusion
  • For infants and toddlers, born at full term of pregnancy (≥37 weeks) and with a birth weight ≥ 2.5 Kg or born after a gestation period of period above 28 (> 28 weeks) through 36 weeks with a birth weight ≥ 1.5 Kg and in both cases medically stable as assessed by the investigator, based on the following definition: "Medically stable" refers to the condition of premature infants who do not require significant medical support or ongoing management for debilitating disease and who have demonstrated a clinical course of sustained recovery by the time they receive the first dose of study intervention
  • Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and judgement of the investigator

Participants are 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 since birth for infants; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months or since birth for and infants)
  • History of any meningitis infection, confirmed either clinically, serologically, or microbiologically
  • At high risk of meningococcal infection during the study
  • Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances
  • Individual with active tuberculosis
  • History of Guillain-Barré syndrome
  • For Stage 3 infants: History of intussusception
  • Previous vaccination against meningococcal serogroups A, B, C, W, and/or Y with an investigational or marketed vaccine
  • For Stage 3 infants: receipt of the first dose of rotavirus vaccine less than 28 days before the first trial vaccination

NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sources for eligibility
clinicaltrials.gov

  • Hospital das Clínicas da Universidade Federal de Minas Gerais- Site Number : 0760001Belo Horizonte, Brazil
  • Curitiba, Brazil
  • Investigational Site Number : 2030003Jindřichův Hradec, Czechia
  • Investigational Site Number : 2030004Ostrava, Czechia
  • Investigational Site Number : 2030007Pilsen, Czechia
  • Investigational Site Number : 2030008Prague, Czechia
  • Investigational Site Number : 2030009Prague, Czechia
  • Investigational Site Number : 2080002Hvidovre, Denmark
  • Investigational Site Number : 2080003Odense, Denmark
  • Investigational Site Number : 2460006Espoo, Finland
  • Investigational Site Number : 2460001Helsinki, Finland
  • Investigational Site Number : 2460008Helsinki, Finland
  • Investigational Site Number : 2460005Jarvenpaa, Finland
  • Investigational Site Number : 2460004Oulu, Finland
  • Investigational Site Number : 2460002Seinäjoki, Finland
  • Investigational Site Number : 2460007Tampere, Finland
  • Investigational Site Number : 2760008Herxheim, Germany
  • Investigational Site Number : 2760006Hürth, Germany
  • Investigational Site Number : 2760007Hürth, Germany
  • Investigational Site Number : 2760005Krefeld, Germany
  • Investigational Site Number : 2760009Mönchengladbach, Germany
  • Investigational Site Number : 2760004Schönau am Königssee, Germany
  • Investigational Site Number : 2760003Wolfsburg, Germany
  • Investigational Site Number : 3400001San Pedro Sula, Honduras
  • Investigational Site Number : 3400002Tegucigalpa, Honduras

And 14 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2023
  • 2023-510465-10
Sources for references
clinicaltrials.gov

Related records

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Targets (4)