Testing a new meningococcal vaccine in young children

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).

This study is testing a new meningococcal vaccine in young children to see if it is safe and works well when given alone or with other routine vaccines.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 750 (estimated)
• Ages: 56 Days to 9 Years
• Sex: All
• Sponsor: Sanofi (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation, prednisone
• Locations: 18 sites (Ostrava and 17 other locations)
• Trial ID: NCT06647407 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and immune response of a new pentavalent meningococcal ABCYW vaccine in children under 10 years old. The study is divided into three stages, assessing the vaccine's effectiveness when given alone or alongside routine pediatric vaccines in toddlers and infants. Participants will be monitored for up to 19 months to determine the vaccine's safety and immunogenicity compared to existing licensed meningococcal vaccines.

Who should consider this trial

Good fit: Ideal candidates are healthy children aged 2 to 9 years, toddlers aged 12 to 15 months, or infants aged 56 to 89 days.

Not a fit: Patients with significant medical conditions or those requiring ongoing medical support may not benefit from this study.

Why it matters

Potential benefit: If successful, this vaccine could provide enhanced protection against meningococcal disease in young children.

How similar studies have performed: Previous studies of meningococcal vaccines have shown promising results, indicating potential for success with this new approach.

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

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.

Where this trial is running

Ostrava and 17 other locations

• Investigational Site Number : 2030004 — Ostrava, Czechia (Recruiting)
• Investigational Site Number : 2030007 — Plzeň, Czechia (Recruiting)
• Investigational Site Number : 2030008 — Praha 8, Czechia (Recruiting)
• Investigational Site Number : 2080002 — Hvidovre, Denmark (Recruiting)
• Investigational Site Number : 2460001 — Helsinki, Finland (Recruiting)
• Investigational Site Number : 2760004 — Schönau Am Königssee, Germany (Recruiting)
• Investigational Site Number : 3400001 — San Pedro Sula, Honduras (Recruiting)
• Investigational Site Number : 3400002 — Tegucigalpa, Honduras (Recruiting)
• Investigational Site Number : 3400003 — Tegucigalpa, Honduras (Recruiting)
• Investigational Site Number : 6160005 — Trzebnica, Dolnoslaskie, Poland (Recruiting)
• Investigational Site Number : 6160006 — Bydgoszcz, Kujawsko-pomorskie, Poland (Recruiting)
• Investigational Site Number : 6160003 — Warsaw, Mazowieckie, Poland (Recruiting)
• Investigational Site Number : 6160004 — Siemianowice Slaskie, Slaskie, Poland (Recruiting)
• Investigational Site Number : 6160001 — Lodz, Poland (Recruiting)
• Investigational Site Number : 6160002 — Warszawa, Poland (Recruiting)
• Investigational Site Number : 7240007 — Seville, Sevilla, Spain (Recruiting)
• Investigational Site Number : 7240009 — Madrid, Spain (Recruiting)
• Investigational Site Number : 7240004 — Madrid, Spain (Recruiting)

Study contacts

• Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)

Conditions Meningococcal Immunization; Healthy Volunteers