Study on an Investigational Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Administered as a 5- and/or 10-year Booster Dose in Children and Adolescents Vaccinated 5 or 10 Years Earlier as 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

23 Aug 2022 → ongoing

Decision date (initial)

2024-05-03

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Sanofi Pasteur

External identifiers

EU CT number

2023-510145-25-00

EudraCT number

2021-000104-38

WHO UTN

U1111-1255-4941

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Others, Prophylaxis

• The purpose of the MEQ00073 study is to evaluate the immunogenicity and safety of a booster dose and describe the immune persistence of a priming dose of MenACYW conjugate vaccine in children and adolescents in Finland, Germany, Spain, and Hungary, who had been vaccinated with MenACYW conjugate vaccine approximately 5 or 10 years earlier as toddlers as part of the MET51 study, and to describe the immunogenicity and safety of a second booster dose and the persistence of a first booster dose of MenACYW conjugate vaccine in adolescents who had been vaccinated with MenACYW conjugate vaccine approximately 5 years earlier as children.
• To demonstrate the vaccine seroresponse sufficiency of meningococcal serogroups A, C, W, and Y after the administration of a booster dose of MenACYW conjugate vaccine in children who received 1 dose of MenACYW conjugate vaccine approximately 5 years earlier as toddlers (Group 1)

Secondary objectives 3

1. To describe antibody persistence and antibody responses of meningococcal serogroups A, C, W, and Y in children and adolescents who received MenACYW conjugate vaccine 5 or 10 years earlier as toddlers and in children who received booster dose 5 years after primary dose of MenACYW conjugate vaccine as toddlers
2. To describe antibody responses to tetanus toxoid before and 30 days after administration of each booster dose of MenACYW vaccine in children and adolescents who received MenACYW vaccine 5 or 10 years earlier as toddlers and in children who received a booster dose 5 years after primary dose as toddlers
3. To describe antibody responses to meningococcal serogroup C before and 30 days after administration of a booster dose of MenACYW in children and adolescents who received MenACYW vaccine 5 or 10 years earlier as meningococcal vaccine naïve toddlers or MenC-primed toddlers and in adolescents who received booster dose as children 5 years after receiving the primary dose (MET51 study)

Conditions and MedDRA coding

Meningococcal infection

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Received MenACYW vaccine in MET51 study (Groups 1 and 3) and completed the study (attended Visit 2)
2. Participant and parent/ legally acceptable representative (LAR) are able to attend all scheduled visits and to comply with all trial procedures
3. Covered by health insurance, if required by local regulations
4. Assent form (AF) has been signed and dated by the participant (if applicable) and informed consent form (ICF) has been signed and dated by the parent(s) or another LAR and by an independent witness, if required by local regulations

Exclusion criteria 16

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 trial (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 (GBS)
5. Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid containing vaccine
6. Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances
7. Verbal report by parent or LAR of thrombocytopenia or suspected thrombocytopenia, contraindicating intramuscular (IM) vaccination
8. Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination
9. Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (ie, mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, W, or Y) with the exception of licensed MenC vaccination received during infancy (MET51 Group 3), of the single dose of meningococcal vaccine administered as part of study MET51 (Group 1 and 3) and of Meningococcal B vaccine
10. Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following trial vaccination except for influenza vaccination, which may be received at least 2 weeks before or after study vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines
11. Receipt of immune globulins, blood or blood-derived products in the past 3 months
12. Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
13. Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
14. Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
15. Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
16. Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Vaccine seroresponse against meningococcal serogroups A, C, W, and Y

Secondary endpoints 15

1. Antibody titers against meningococcal serogroups A, C, W, and Y before the administration of a booster dose of MenACYW conjugate vaccine (Group 1 and 2)
2. Antibody titers against meningococcal serogroups A, C, W, and Y at Visit 2 (Group 2)
3. Antibody titers against meningococcal serogroups A, C, W, and Y at Visit 3 (Group 1)
4. Antibody titers against meningococcal serogroups A, C, W, and Y at Visit 1 and Visit 2 (Group 1)
5. Antibody titers against meningococcal serogroups A, C, W, and Y at Visit 2 and Visit 3 (Group 2)
6. Antibody titers against meningococcal serogroups A, C, W, and Y at Visit 3 and Visit 4 (Group 1)
7. Antibody concentrations against tetanus toxoid at Visit 1 and Visit 2 (Group 1)
8. Antibody concentrations against tetanus toxoid at Visit 3 and Visit 4 (Group 1)
9. Antibody concentrations against tetanus toxoid at Visit 2 and Visit 3 (Group 2)
10. Antibody titers against meningococcal serogroup C Visit 3 and Visit 4 (Group 1)
11. Antibody titers against meningococcal serogroup C Visit 2 and Visit 3 (Group 2)
12. Number of participants with immediate unsolicited systemic adverse events (AEs)
13. Number of participants with solicited injection site reactions and systemic reactions
14. Number of participants with unsolicited AEs
15. Number of participants with serious adverse events (SAEs) and Adverse Event of Special Interest (AESI)

Investigational products

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

Test 1

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 6

Locations

4 EU/EEA countries · 26 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 47 files

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

Application history

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