Active — Not RecruitingPhase 1/2

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

Brazil, Czechia750 participantsStarted 2024-11-05

Plain-language 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.

Who can participate

Age range56 Days – 9 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 me…

What they're measuring

Number of participants with unsolicited immediate adverse events (AEs)

Timeframe: Within 30 minutes after each vaccination

Number of participants with solicited injection site reactions or systemic reactions

Timeframe: Within 7 days after each vaccination

Number of participants with unsolicited AEs

Timeframe: Within 30 days after each vaccination

Number of participants with serious adverse events (SAEs)

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

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 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

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

Trial details

NCT IDNCT06647407

SponsorSanofi Pasteur, a Sanofi Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-05-17

View on ClinicalTrials.gov More Meningococcal Immunization trials

Plain-language summary

Who can participate

Age range56 Days – 9 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of participants with unsolicited immediate adverse events (AEs)

Timeframe: Within 30 minutes after each vaccination

Number of participants with solicited injection site reactions or systemic reactions

Timeframe: Within 7 days after each vaccination

Number of participants with unsolicited AEs

Timeframe: Within 30 days after each vaccination

Number of participants with serious adverse events (SAEs)

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

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 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

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