Study on immunogenicity and safety of a meningococcal ACYW conjugate vaccine in healthy infants and toddlers

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Sanofi Pasteur

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

12 Mar 2024 → 13 Mar 2026

Decision date (initial)

2024-02-13

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Sanofi Pasteur

External identifiers

EU CT number

2023-508177-85-00

WHO UTN

U1111-1280-6981

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Others, Prophylaxis

- To demonstrate non-inferiority of the antibody response in terms of geometric mean titers (GMTs) against meningococcal serogroups A, C, W, and Y, following the administration of a 2-dose series (1+1) of MenACYW conjugate vaccine compared to a 2 - dose series (1+1) of Nimenrix®, when each vaccine is administered to infants (dose 1) at 6-7 months of age and toddlers (dose 2) at 12-13 months of age
- To demonstrate non inferiority of the antibody response in terms of vaccine seroresponse against meningococcal serogroups A, C, W, and Y, following the administration of a 2-dose series (1+1) of MenACYW conjugate vaccine compared to a 2-dose series (1+1) of Nimenrix®, when each vaccine is administered to infants (Dose 1) at 6-7 months of age and toddlers (Dose 2) at 12-13 months of age

Secondary objectives 5

1. To compare seroprotection against meningococcal serogroups ACWY, 30 days after administration of priming dose of MenACYW conjugate vaccine versus priming dose of Nimenrix® in infants 6-7 months old
2. To describe antibody response against meningococcal serogroups ACWY, before vaccination and 30 days after administration of priming dose of MenACYW vaccine or Nimenrix® in infants 6-7 months old
3. To describe antibody response against meningococcal serogroups ACWY, before and 30 days after administration of booster dose of MenACYW vaccine or Nimenrix® in toddlers 12-13 months old
4. To describe antibody response against meningococcal serogroups ACWY, before priming dose as infants 6 – 7 months of age and 30 days following administration of booster dose of MenACYW vaccine or Nimenrix® as toddlers at 12-13 months old
5. To describe safety profile of MenACYW vaccine and Nimenrix® after priming dose administered to infants at 6-7 months old and after booster dose administered at 12-13 months old

Conditions and MedDRA coding

Healthy volunteers (Meningococcal infection)

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. Aged 6 to 7 months on the day of inclusion
2. Participants who are healthy as determined by medical evaluation including medical history, physical examination and judgment of the Investigator

Exclusion criteria 9

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 long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks) within the past 3 months
2. History of meningococcal infection, confirmed either clinically, serologically, or microbiologically
3. 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)
4. Personal history of Guillain-Barré syndrome
5. Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine
6. 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
7. 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
8. 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.
9. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Geometric mean titers (GMTs) of Antibodies against meningococcal serogroups A, C, W and Y
2. Vaccine Seroresponse to meningococcal serogroups A, C, W and Y assessed by hSBA

Secondary endpoints 13

1. hSBA antibody titers ≥ 1:8 against meningococcal serogroups A, C, W, and Y
2. hSBA antibody titers against meningococcal serogroups A, C, W, and Y
3. hSBA antibody titers ≥ several pre-defined thresholds against meningococcal serogroups A, C, W, and Y
4. Percentage of Participants who achieved ≥4-fold rise in antibody titers over baseline measured by hSBA
5. hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse
6. Rabbit complement (rSBA) antibody titers against meningococcal serogroups A, C, W, and Y
7. rSBA antibody titers ≥ several pre-defined thresholds against meningococcal serogroups A, C, W, and Y
8. Percentage of Participants who achieved ≥4-fold rise in antibody titers over baseline measured by rSBA
9. rSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse
10. Number of participants with immediate adverse events (AEs)
11. Number of participants with solicited injection site reactions or systemic reactions
12. Number of participants with unsolicited AEs
13. Number of participants with serious adverse events (SAEs)

Investigational products

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

Test 1

Comparator 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Sanofi Pasteur

Sponsor organisation

Sanofi Pasteur

Address

14 Espace Henry Vallee

City

Lyon

Postcode

69007

Country

France

Scientific contact point

Organisation

Sanofi Pasteur

Contact name

Clinical Sciences and Operations

Public contact point

Organisation

Sanofi Pasteur

Contact name

Clinical Sciences and Operations

Third parties 4

Locations

6 EU/EEA countries · 58 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 117 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