Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adults, Adolescents, Children, and Toddlers in India and Healthy Adolescents and Children in the Republic of South Africa

Healthy Volunteers (Meningococcal Infection) Clinical Trial

— MET55  

Official title:

Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adults, Adolescents, Children, and Toddlers in India and Healthy Adolescents and Children in the Republic of South Africa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04143061
• Other study ID #: MET55
• Secondary ID: U1111-1183-6581
• Status: Completed
• Phase: Phase 3
• Start date: December 30, 2019
• Est. completion date: January 28, 2023

Study information

• Verified date: January 2024
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This will be a Phase III, modified double-blind (open-label for toddlers in India), randomized, parallel-group, active-controlled, step-wise, multi-center study to compare and describe the immunogenicity and safety of MenACYW conjugate vaccine when administered as a single dose in healthy adults, adolescents, children, and toddlers in India and a modified double-blind, randomized, parallel-group, active-controlled, multi-center study to compare and describe the immunogenicity and safety of MenACYW conjugate vaccine when administered as a single dose in healthy adolescents and children in the Republic of South Africa (RSA).

Description:

Study duration per participant is approximately 31 to 45 days

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1328
• Est. completion date: January 28, 2023
• Est. primary completion date: January 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Months and older

Eligibility

Inclusion Criteria:

• Age in the defined range on the day of inclusion: For Adults: Aged = 18 years on the day of inclusion For Children and Adolescents: Aged 2 to 17 years on the day of inclusion For Toddlers: Aged 12 to 23 months† on the day of inclusion

• Z-score of = -2 standard deviations (SD) on the Weight-for-height table of the World Health Organization (WHO) Child Growth Standards: For toddlers and children: Toddlers aged 12 to 23 months and Children aged 2 to 5 years must have a Z-score of = -2 SD on the Weight-for-height table of the WHO Child Growth Standards

• Informed consent obtained For adults: Informed consent form has been signed and dated by the subject and by an independent witness, if required by local regulations For toddlers, children, and adolescents: Assent form has been signed and dated by the subject (for subjects 7 to 17 years of age), and informed consent form has been signed and dated by the parent(s) or legally acceptable representative and by an independent witness, if required by local regulations

• Able to attend all scheduled visits and to comply with all trial procedures For adults: Able to attend all scheduled visits and to comply with all trial procedures For toddlers, children, and adolescents: Participants and parent / legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures

• For Toddlers: All toddlers must be due to receive an age-recommended RPV on D0 - - - -

Exclusion Criteria:

• Participant is pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination. To be considered of non-childbearing potential, a female must be pre-menarche, or post-menopausal for at least 1 year, or surgically sterile

• Participation at the time of study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure

• Receipt of any vaccine in the 4 weeks (28 days) preceding the IMP or planned receipt of any vaccine in the 4 weeks following vaccination except for oral poliovirus vaccine (OPV) in India, received during national immunization days. In India, OPV may be received with a gap of at least 2 weeks before the IMP. This exception includes monovalent and bivalent OPV.

• Previous vaccination against meningococcal disease with either the IMP or another vaccine (i.e., mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal B serogroup containing vaccine)

• Receipt of immune globulins, blood or blood-derived products in the past 3 months

• 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)

• History of meningococcal infection, confirmed either clinically, serologically, or microbiologically

• At high risk for meningococcal infection during the trial (specifically, but not limited to, subjects with persistent complement deficiency, with anatomic or functional asplenia, or subjects traveling to countries with high endemic or epidemic disease)

• Known systemic hypersensitivity to latex or to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances

• Verbal report of thrombocytopenia, as reported by the subject or the subject's parent / legally acceptable representative, contraindicating intramuscular vaccination in the Investigator's opinion

• Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination in the Investigator's opinion

• Personal history of Guillain-Barré syndrome

• Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine within 10 years of the proposed study vaccination

• Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily

• Current alcohol abuse or drug addiction

• Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion

• Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.

• Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination, febrile illness (temperature = 38.0°C), persistent diarrhea, vomiting. A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided

• Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw

• Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study

Related Conditions & MeSH terms

• Healthy Volunteers (Meningococcal Infection)
• Meningococcal Infections

Intervention

Biological:
• Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine
Pharmaceutical form: solution for injection; Route of administration: intramuscular, 0.5 mL
• Meningococcal polysaccharide (serogroups A,C,Y and W-135) diphtheria toxoid conjugate vaccine
Pharmaceutical form: sterile aqueous solution; Route of administration: intramuscular, 0.5 mL
• Meningococcal polysaccharide (serogroups A, C, Y and W-135) vaccine
Pharmaceutical form: reconstituted solution for injection; Route of administration: intramuscular, 0.5 mL
• Hepatitis A vaccine
Pharmaceutical form: Suspension for injection in prefilled syringe Route of administration: Intramuscular, 0.5 mL
• Measles, Mumps, and Rubella Virus Vaccine (MMR)
Pharmaceutical form: Lyophilized powder for injection Route of administration: Subcutaneous or Intramuscular, 0.5 mL
• Pneumococcal 13-valent conjugate vaccine
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular, 0.5 mL
• DTwP-HepB-Hib-IPV vaccine
Pharmaceutical form: Solution for injection Route of administration: Intramuscular, 0.5 mL
• Varicella vaccine
Pharmaceutical form: Sterile powder and diluent for injection in prefilled syringe Subcutaneous, 0.5 mL Route of administration: Pharmaceutical form:

Locations

Country	Name	City	State
India	Investigational Site Number : 3560002	Bangalore
India	Investigational Site Number : 3560016	Belgaum
India	Investigational Site Number : 3560007	Chennai
India	Investigational Site Number : 3560004	Hyderabad
India	Investigational Site Number : 3560011	Kolkata
India	Investigational Site Number : 3560012	Mysore
India	Investigational Site Number : 3560015	Odisha
India	Investigational Site Number : 3560003	Pune
India	Investigational Site Number : 3560008	Pune
India	Investigational Site Number : 3560010	Punjab
South Africa	Investigational Site Number : 7100004	Bertsham
South Africa	Investigational Site Number : 7100007	Bloemfontein
South Africa	Investigational Site Number : 7100002	Cape Town
South Africa	Investigational Site Number : 7100005	Cape Town
South Africa	Investigational Site Number : 7100001	Middelburg
South Africa	Investigational Site Number : 7100006	Pretoria
South Africa	Investigational Site Number : 7100003	Soweto

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Countries where clinical trial is conducted

India,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antibody titers = 1:8 against meningococcal serogroups A, C, Y, and W	% of participants achieving antibody titers = predefined threshold of 1:8	Day 30 after vaccination
Primary	Antibody titers = 1:8 against meningococcal serogroups A, C, Y, and W	% of participants achieving antibody titers measured by hSBA = predefined threshold of 1:8.	D30 after vaccination
Secondary	Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA	Antibody titers are measured by hSBA and summarized as geometric mean titers (GMTs)	Day 0 and Day 30 after vaccination
Secondary	Antibody titers against meningococcal serogroups A, C, Y, and W measured by rSBA	Antibody titers are measured by rSBA and summarized as GMTs	Day 0 and Day 30 after vaccination
Secondary	Antibody titers = several pre-defined thresholds against meningococcal serogroups A, C, Y, and W measured by hSBA	Antibody titers are measured by hSBA and summarized as % of participants achieving antibody titers = predefined thresholds	Day 0 and Day 30 after vaccination
Secondary	Antibody titers = several pre-defined thresholds against meningococcal serogroups A, C, Y, and W measured by rSBA	Antibody titers are measured by rSBA and summarized as % of participants achieving antibody titers = predefined thresholds	Day 0 and Day 30 after vaccination
Secondary	Antibody titers against meningococcal serogroups A, C, Y, and W	Antibody titers are measured by hSBA and summarized as geometric mean titers (GMTs)	D0 and D30 after vaccination
Secondary	Antibody titers against meningococcal serogroups A, C, Y, and W (in a subset)	Antibody titers are measured by serum bactericidal assay using baby rabbit complement (rSBA) and summarized as GMTs	D0 and D30 after vaccination
Secondary	Antibody titers = several pre-defined thresholds against meningococcal serogroups A, C, Y, and W	Antibody titers are measured by hSBA and summarized as % of participants achieving antibody titers = predefined thresholds	D0 and D30 after vaccination
Secondary	Antibody titers = several pre-defined thresholds against meningococcal serogroups A, C, Y, and W (in a subset)	Antibody titers are measured by rSBA and summarized as % of participants achieving antibody titers = predefined thresholds	D0 and D30 after vaccination