Safety and immunogenicity of an investigational Pentavalent Meningococcal ABCYW vaccine against meningococcal disease in children, toddlers, and infants

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Sanofi Pasteur Inc.

Participant type

Pediatric, Healthy volunteers

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

Trial duration

10 Mar 2025 → ongoing

Decision date (initial)

2025-01-22

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2023-510465-10-00

WHO UTN

U1111-1297-9961

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Others, Prophylaxis

- To describe the safety profile of the MenPenta vaccine formulations in healthy children (Stage 1), toddlers (Stage 2), and infants (Stage 3)
- To describe the immune response to the MenPenta vaccine formulations and the comparator vaccines 30 days after the 2nd dose of vaccination given at approximately 4 months of age when administered to healthy infants in Stage 3 as measured by hSBA in the A, C, W-135, Y, and the reference MenB strains
- To describe the immune response to the MenPenta vaccine formulations and the comparator vaccines 30 days after the 3rd dose of vaccination given at 12-15 MoA when administered to healthy infants in Stage 3 as measured by hSBA in the A, C, W-135, Y, and reference MenB strains
- To describe immune response to MenPenta vaccine formulations and comparator vaccines at each time point when administered to healthy children (Stage 1) and toddlers (Stage 2) in A, C, W-135, Y, and reference MenB strains

Secondary objectives 1

1. To describe immune response (breadth of coverage) in a panel of MenB strains 30 days after last dose of vaccination against serogroup B when administered to healthy children (Stage 1), toddlers (Stage 2), and infants (Stage 3)

Conditions and MedDRA coding

Meningococcal immunization

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

EMA paediatric investigation plan (PIP)

EMEA-003379-PIP01-22

Plan to share IPD

Yes

IPD plan description

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​

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. 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
2. 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
3. Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and judgement of the investigator

Exclusion criteria 8

1. 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)
2. History of meningococcal meningitis infection, confirmed either clinically, serologically, or microbiologically
3. At high risk of meningococcal infection during the study
4. 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
5. History of Guillain-Barré syndrome
6. For Stage 3 infants: History of intussusception
7. Previous vaccination against meningococcal serogroups A, B, C, W, and/or Y with an investigational or marketed vaccine
8. For Stage 3 infants: receipt of the first dose of rotavirus vaccine less than 28 days before the first trial vaccination

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 24

1. Number of participants with unsolicited immediate adverse events (AEs)
2. Number of participants with solicited injection site reactions or systemic reactions
3. Number of participants with unsolicited AEs
4. Number of participants with serious adverse events (SAEs)
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
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
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
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
9. Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:4 pre-dose and 1 month after the second dose of vaccination against serogroup B, before and 30 days after third dose in infant participants
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 infant participants
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
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
13. 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) pre-dose and 1 month after the second dose of vaccination against serogroup B, before and 30 days after third dose in infant participants
14. Percentage of participants with hSBA titers less than the lower limit of quantification (LLOQ) against all 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
15. hSBA meningococcal serogroups A, C, W, and Y antibody titers in children and toddlers
16. hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse in children and toddlers
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
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
19. Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:4 in children and toddlers
20. Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:8 in children and toddlers
21. hSBA meningococcal serogroup B (reference MenB strains) vaccine seroresponse in children and toddlers
22. Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (reference MenB strains) in children and toddlers
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
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

Secondary endpoints 6

1. hSBA meningococcal serogroup B (additional MenB strains) vaccine seroresponse in children, toddler and infant participants
2. Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (additional MenB strains) ≥ 1:4 in children, toddler and infant participants
3. Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (additional MenB strains) ≥ 1:8 in children, toddler and infant participants
4. Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (additional MenB strains) in children, toddler and infant participants
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
6. Percentage of participants with hSBA composite seroresponse titers less than LLOQ all additional MenB strains in children, toddler and infant participants

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Comparator 3

Auxiliary 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Sanofi Pasteur Inc.

Sponsor organisation

Sanofi Pasteur Inc.

Address

1 Discovery Drive

City

Swiftwater

Postcode

18370-9100

Country

United States

Scientific contact point

Organisation

Sanofi Pasteur Inc.

Contact name

Clinical Sciences and Operations

Public contact point

Organisation

Sanofi Pasteur Inc.

Contact name

Clinical Sciences and Operations

Third parties 9

Locations

6 EU/EEA countries · 40 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 120 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

9 submissions — initial application plus substantial / non-substantial modifications