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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05794230
Other study ID # MEQ00064
Secondary ID U1111-1225-0926
Status Recruiting
Phase Phase 3
First received
Last updated
Start date March 27, 2023
Est. completion date September 8, 2025

Study information

Verified date November 2023
Source Sanofi
Contact Trial Transparency email recommended (Toll free number for US &
Phone 800-633-1610
Email Contact-US@sanofi.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This open label randomized study will be conducted to evaluate and/or describe the immunogenicity and describe the safety of MenACYW conjugate vaccine when administered in infants and toddlers. It will be conducted in India and the RSA in 2 cohorts: - Cohort I: Infants and toddlers 6 months to 16 months of age - Cohort II: Infants and toddlers 6 weeks to 15 months of age In Cohort I, eligible participants will be randomized in a 1:1 ratio to receive 2 intramuscular (IM) injections (1+1 vaccination schedule) of either MenACYW conjugate vaccine (Groups 1 and 3) or Menactra vaccine (Groups 2 and 4), co-administered with routine pediatric vaccines. In Cohort II, eligible participants will be randomized in a 2:1 ratio to receive either 3 IM injections (2+1 vaccination schedule) of MenACYW conjugate vaccine co-administered with routine pediatric vaccines (Groups 5 and 7) or routine pediatric vaccines only (Groups 6 and 8). The primary objectives of this study are: - To demonstrate the non-inferiority of immunogenicity of 2 doses of MenACYW conjugate vaccine compared to 2 doses of Menactra® vaccine in infants and toddlers 6 months to 16 months of age in terms of serum bactericidal assay using human complement (hSBA) seroprotection (titers ≥ 1:8) in India and the Republic of South Africa (RSA) - To demonstrate the vaccine immune sufficiency of 3 doses of MenACYW conjugate vaccine in infants and toddlers 6 weeks to 15 months of age in terms of hSBA seroprotection (titers ≥ 1:8) in India and the RSA The secondary objectives of this study are: - To describe the antibody titers to the meningococcal serogroups A, C, Y, and W: - before and 30 days post primary series of MenACYW conjugate vaccine and before and 30 days post booster dose of MenACYW conjugate vaccine in infants and toddlers 6 weeks to 15 months of age in India and the RSA when administered concomitantly with other age-recommended vaccines. - before and after 30 days post each dose of MenACYW conjugate vaccine or Menactra vaccine in infants and toddlers 6 months to 16 months of age in India and the RSA when administered concomitantly with other age-recommended vaccines. - To describe the antibody responses against the antigens of the other age-recommended vaccines when administered concomitantly with MenACYW conjugate vaccine: - in infants and toddlers 6 weeks to 15 months of age in India and the RSA. - in infants and toddlers 6 months to 16 months of age in India and the RSA. The duration of each participant's active participation in the study will be approximately 10 to 11 months for Cohort I and 13,5 to 14,5 months for Cohort II.


Description:

The duration of each participant's active participation in the study will be approximately 10 to 11 months for Cohort I and 13,5 to 14,5 months for Cohort II.


Recruitment information / eligibility

Status Recruiting
Enrollment 1528
Est. completion date September 8, 2025
Est. primary completion date September 8, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Weeks to 6 Months
Eligibility Inclusion Criteria: - Cohort I: 6 months of age (180 to 209 days of age) on the day of the first study visit - Cohort II: 6-8 weeks of age (42 to 62 days of age) on the day of the first study visit - Healthy infants as determined by medical history, physical examination, and judgment of the Investigator - Cohort I: Z-score = 2 SD on the Weight-for-age table of the WHO Child Growth Standards. - Cohort II: Born at full term of pregnancy (= 37 weeks) and with a birth weight = 2.5 kg. - Participant and parent/ legally acceptable representative (LAR) are able to attend all scheduled visits and to comply with all study procedures Exclusion Criteria: - Participation at the time of study enrollment (or in the 4 weeks preceding the first study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure. - Receipt of any vaccine in the 4 weeks preceding the first study vaccination (except for Bacille Calmette-Guérin [BCG], birth dose OPV and birth dose of HepB vaccine) or planned receipt of any vaccine in the 4 weeks following each study vaccination except for the following vaccinations, which may be received at least 2 weeks before or 2 weeks after any study vaccination. This exception includes monovalent pandemic influenza vaccines, multivalent influenza vaccines, any COVID-19 vaccines, and administration of OPV on National Immunization Day in India. - Previous vaccination against meningococcal disease with either the study vaccine or another vaccine (ie, mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal B serogroup-containing vaccine). - For Cohort II - Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis (other than birth dose of OPV), Hepatitis A, measles, mumps, rubella, varicella; and of Hib, Streptococcus pneumoniae, and/or RV infection or disease. - For Cohort II - Previous vaccination with more than 1 dose of HepB 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). *Note: Participants with a history of HIV but without evident severe immunosuppression can be included. - Family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated. - Individuals with active tuberculosis. - History of meningococcal infection, confirmed either clinically, serologically, or microbiologically. - 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 travelling to countries with high endemic or epidemic disease). - History of intussusception. - History of any neurologic disorders, including any seizures and progressive neurologic disorders. - History of Guillain-Barré syndrome (GBS). - Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the study or to a vaccine containing any of the same substances, including neomycin, gelatin, and yeast. - Verbal report of thrombocytopenia, as reported by the parent/LAR, contraindicating IM vaccination in the Investigator's opinion. - Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination in the Investigator's opinion. - Chronic illness (including, but not limited to, cardiac disorders, congenital heart disease, chronic lung disease, renal disorders, auto-immune disorders, diabetes, psychomotor diseases, and known congenital or genetic diseases) that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion. - 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. - Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw. - Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
Liquid solution - intramuscular
Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Liquid solution - intramuscular
Oral bivalent types 1 and 3; Poliomyelitis Vaccine (OPV)
Oral suspension - oral
Pneumoccocal Vaccine
Suspension for injection - intramuscular
Measles, Mumps, and Rubella Vaccine live (MMR) - TRESIVAC®
Lyophilized powder for injection - subcutaneous
DTwP-HepB-Hib-IPV vaccine
Suspension - intramuscular
DTaP-IPV-Hib-HepB vaccine
Liquid solution - intramuscular
Hepatitis A vaccine - HAPIBEV™
Suspension for injection - intramuscular
Rotavirus vaccine
Oral solution - oral
Typhoid conjugate vaccine (TCV)
Suspension for injection - intramuscular
Measles vaccine - MeasBio®
Freeze-dried powder for reconstitution and injection - subcutaneous
Varicella vaccine live - VARIPED®
Sterile powder and diluent for injection - subcutaneous
Varicella vaccine live - Onvara
Lyophilized powder for injection - subcutaneous
Measles, Mumps, and Rubella Vaccine live (MMR) - OMZYTA®
Lyophilized powder for injection - subcutaneous
Hepatitis A vaccine - Avaxim 80 U
Suspension for injection - intramuscular

Locations

Country Name City State
India Investigational Site Number : 3560006 Chennai
India Investigational Site Number : 3560007 Hyderabad
India Investigational Site Number : 3560016 Kanpur
India Investigational Site Number : 3560009 Kolkata
India Investigational Site Number : 3560011 Manipal
India Investigational Site Number : 3560004 Mysore
India Investigational Site Number : 3560013 Mysore
India Investigational Site Number : 3560003 New Delhi
India Investigational Site Number : 3560001 Pune
India Investigational Site Number : 3560002 Pune
South Africa Investigational Site Number : 7100002 Cape Town
South Africa Investigational Site Number : 7100003 Cape Town
South Africa Investigational Site Number : 7100006 George
South Africa Investigational Site Number : 7100005 Johannesburg
South Africa Investigational Site Number : 7100001 Middelburg

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 Percentage of participants with anti-meningococcal serogroups A, C, Y, W antibody titers above predefined thresholds after 2 doses of MenACYW conjugate vaccine compared to 2 doses of Menactra® vaccine in infants and toddlers 6 months to 16 months of age Antibody (Ab) titers against meningococcal serogroups A, C, Y, and W will be measured in infants and toddlers 6 months to 16 months of age ([Group 1 + Group 3] versus [Group 2 + Group 4])
The following threshold values will be considered: = 1:8
30 days after the second vaccination
Primary Percentage of participants with anti-meningococcal serogroups A, C, Y, W Ab titers above predefined thresholds after 3 doses of MenACYW conjugate vaccine in infants and toddlers 6 weeks to 15 months of age Ab titers against meningococcal serogroups A, C, Y, and W will be measured in infants and toddlers 6 months to 15 months of age (Group 5 + Group 7)
The following threshold values will be considered: = 1:8
30 days after the booster vaccination
Secondary Geometric Mean Titers (GMTs) of Ab against meningococcal serogroups A, C, Y, and W when MenACYW conjugate vaccine administered concomitantly with other age-recommended vaccine in infants 6 weeks to 15 months of age Ab titers against meningococcal serogroups A, C, Y, and W will be measured Group 5 versus Group 6 in India Group 7 versus Group 8 in RSA Group 5 + Group 7 versus Group 6 + Group 8 Baseline; 30 days after primary series of vaccination; Before and 30 days after booster vaccination
Secondary Geometric Mean Titers Ratio (GMTR) of Ab against meningococcal serogroups A, C, Y, and W when MenACYW conjugate vaccine administered concomitantly with other age-recommended vaccine in infants 6 weeks to 15 months of age Ab titers against meningococcal serogroups A, C, Y, and W will be measured Group 5 versus Group 6 in India Group 7 versus Group 8 in RSA Group 5 + Group 7 versus Group 6 + Group 8 Baseline; 30 days after primary series of vaccination; Before and 30 days after booster vaccination
Secondary GMTs of Ab against meningococcal serogroups A, C, Y, and W when MenACYW conjugate vaccine or Menactra vaccine when administered concomitantly with other age-recommended vaccines in infants and toddlers 6 months to 16 months of age Ab titers after vaccination with MenACYW conjugate vaccine or Menetra® will be measured Group 1 versus Group 2 in India Group 3 versus Group 4 in the RSA Group 1 + Group 3 versus Group 2 + Group 4 Baseline; Before and 30 days after each vaccination
Secondary GMTR of Ab against meningococcal serogroups A, C, Y, and W when MenACYW conjugate vaccine or Menactra vaccine when administered concomitantly with other age-recommended vaccines in infants and toddlers 6 months to 16 months of age Ab titers after vaccination with MenACYW conjugate vaccine or Menetra® will be measured Group 1 versus Group 2 in India Group 3 versus Group 4 in the RSA Group 1 + Group 3 versus Group 2 + Group 4 Baseline; Before and 30 days after each vaccination
Secondary Percentage of participants with anti-meningococcal serogroups A, C, Y, and W Ab titers met the predefined criteria when MenACYW conjugate vaccine administered concomitantly with other age-recommended vaccine in infants 6 weeks to 15 months of age Ab titers against meningococcal serogroups A, C, Y, and W will be measured
hSBA titer = 1:4 and = 1:8
hSBA titer = 4-fold rise from pre-vaccination to post-vaccination
hSBA vaccine seroresponse
Baseline; 30 days after primary series of vaccination; Before and 30 days after booster vaccination
Secondary Percentage of participants with anti-meningococcal serogroups A, C, Y, and W Ab titers met the predefined criteria when MenACYW conjugate vaccine administered concomitantly with other age-recommended vaccine in infants and toddlers 6 to 16 months of age Ab titers after vaccination with MenACYW conjugate vaccine or Menetra® will be measured
hSBA titer = 1:4 and = 1:8
hSBA titer = 4-fold rise from pre-vaccination to post-vaccination
hSBA vaccine seroresponse
Baseline; Before and 30 days after each vaccination
Secondary GMCs of Ab against the antigens of age-recommended vaccines in infants and toddlers 6 weeks to 15 months of age GMCR of Ab against the antigens of age-recommended vaccines in infants and toddlers 6 weeks to 15 months of age The following Ab concentrations will be measured:
- Anti-pertussis Ab concentrations (pertussis toxoid [PT], filamentous hemagglutinin [FHA]), fimbriae types 2, 3 [FIM], and pertactin [PRN])
Baseline
Secondary GMCR of Ab against the antigens of age-recommended vaccines in infants and toddlers 6 weeks to 15 months of age The following Ab concentrations will be measured:
- Anti-pertussis Ab concentrations (pertussis toxoid [PT], filamentous hemagglutinin [FHA], fimbriae types 2, 3 [FIM], and pertactin [PRN])
Baseline
Secondary GMCs/GMTs of Ab against the antigens of age-recommended vaccines in infants and toddlers 6 weeks to 15 months of age The following Ab concentrations/titers will be measured:
against the antigens of DTwP-HepB-Hib/DTaP-IPV-Hib-HepB
against the antigens of PCV13
against the antigens of RV (serum RV immunoglobulin [Ig]A)
against the antigens of measles, mumps and rubella
against the antigens of varicella vaccine
30 days after: -Dose 3 of DTwP-HepB-Hib-IPV/DTaP-IPV-Hib-HepB -primary series of PCV13 -booster dose of PCV13 -Dose 2 of measles, mumps and rubella (after Dose 1 in RSA) -first dose of varicella vaccine; Before and 30 days after primary series of RV
Secondary GMCRs/GMTRs of Ab against the antigens of age-recommended vaccines in infants and toddlers 6 weeks to 15 months of age The following Ab concentrations/titers will be measured:
against the antigens of DTwP-HepB-Hib-IPV/DTaP-IPV-Hib-HepB
against the antigens of PCV13
against the antigens of RV (serum RV immunoglobulin [Ig]A)
against the antigens of measles, mumps and rubella
against the antigens of varicella vaccine
30days after-primary series of DTwP-HepB-Hib-IPV/DTaP-IPV-Hib-HepB-primary series of PCV13 -Dose2 of measles,mumps,rubella(after Dose1 in RSA)-Dose1 of varicella vaccine;30days at least after booster dose of PCV13;Before&30days after primary series of RV
Secondary Percentage of participants with Ab concentrations/titers met the predefined criteria in infants and toddlers 6 weeks to 15 months of age The following Ab concentrations/titers will be measured:
Anti-tetanus Ab = 0.01 International Units (IU)/milliliter (mL) and = 0.1 IU/mL
Anti-diphtheria Ab = 0.01 IU/mL and = 0.1 IU/mL
Anti-polyribosyl-ribitol phosphate (PRP) Ab = 0.15 micrograms (µg)/mL and = 1.0 µg/mL
Pertussis vaccine seroresponse for anti-PT, and anti-PT, anti-FHA, anti-FIM, and anti-PRN
Anti-hepatitis B surface antigen (HBsAg) Ab = 10 mIU/mL and = 100 mIU/mL
Anti-poliovirus types 1, 2, and 3 Ab titers = 1:8
Anti-pneumococcal Ab = 0.35 µg/mL
- 30 days after dose 3 of DTwP-HepB-Hib/DTaP-IPV-Hib-HepB - 30 days after primary series of PCV13 and 30 days after the booster dose of PCV13
Secondary Percentage of participants with Ab concentrations/titers met the predefined criteria in infants and toddlers 6 weeks to 15 months of age The following Ab concentrations/titers will be measured:
Anti-RV seroresponse
Anti-measles Ab concentrations (serostatus cutoff: 255 mIU/mL)
Anti-mumps Ab concentrations (serostatus cutoff: 10 Mumps antibody units/mL)
Anti-rubella Ab concentrations (serostatus cutoff: 10 IU/mL)
Anti-varicella Ab concentrations (serostatus cutoff: 5gpELISA unit/mL)
30 days after: -primary series of RV -Dose 2 of measles, mumps and rubella (after Dose 1 in the RSA) -first dose of varicella vaccine
Secondary GMCs/GMTs of Ab against the antigens of age-recommended vaccines in infants and toddlers 6 months to 16 months of age The following Ab concentrations will be measured:
against the antigens of varicella
against the antigens of PCV13
against the antigens of measles, mumps and rubella
against the antigens of DTwP-HepB-Hib-IPV
30 days after:-first dose of varicella vaccine -the booster dose of PCV13 -after Dose 2 of measles, mumps and rubella (after Dose 1 in the RSA) -after booster dose of DTwP-HepB-Hib-IPV
Secondary GMCRs/GMTRs of Ab against the antigens of age-recommended vaccines in infants and toddlers 6 months to 16 months of age The following Ab concentrations/titers will be measured:
against the antigen of varicella
against the antigens of PCV13
against the antigens of measles, mumps and rubella
against the antigens of DTwP-HepB-Hib-IPV
30 days after:-first dose of varicella vaccine -the booster dose of PCV13 -after Dose 2 of measles, mumps and rubella (after Dose 1 in the RSA -after booster dose of DTwP-HepB-Hib-IPV
Secondary Percentage of participants with Ab concentrations/titers met the predefined criteria in infants and toddlers 6 months to 16 months of age The following Ab concentrations/titers will be measured:
anti-pneumococcal Ab concentrations = 0.35 µg/mL
anti-measles Ab concentrations (serostatus cutoff: 255 mIU/mL)
anti-mumps Ab concentrations (serostatus cutoff: 10 Mumps antibody units/mL)
anti-rubella Ab concentrations (serostatus cutoff: 10 IU/mL)
anti-varicella Ab concentrations (serostatus cutoff: 5gpELISA unit/mL)
30 days after :-the booster dose of PCV13 -Dose 2 of measles, mumps and rubella (after Dose 1 in the RSA) -first dose of varicella vaccine
Secondary GMCs of Ab against the antigens of age-recommended vaccines in infants and toddlers 6 months to 16 months of age The following Ab concentrations will be measured:
- Anti-pertussis Ab concentrations (pertussis toxoid [PT], filamentous hemagglutinin [FHA], fimbriae types 2, 3 [FIM], and pertactin [PRN])
Pre-booster dose vaccination of DTwP-HepB-Hib-IPV
Secondary GMCR of Ab against the antigens of age-recommended vaccines in infants and toddlers 6 months to 16 months of age The following Ab concentrations will be measured:
- Anti-pertussis Ab concentrations (pertussis toxoid [PT], filamentous hemagglutinin [FHA], fimbriae types 2, 3 [FIM], and pertactin [PRN])
Pre-booster dose vaccination of DTwP-HepB-Hib-IPV
Secondary Percentage of participants with Ab concentrations/titers met the predefined criteria in infants and toddlers 6 months to 16 months of age The following Ab concentrations/titers will be measured:
anti-tetanus Ab concentrations = 0.01 IU/mL, = 0.1 IU/mL and = 1.0 IU/mL
anti-diphtheria Ab concentrations = 0.01 IU/mL, and = 0.1 IU/mL
anti-PRP Ab concentrations = 0.15 µg)/mL and = 1.0 µg/mL
pertussis vaccine seroresponse for anti-PT, anti-FHA, anti-FIM, and anti-PRN
anti-HBsAg Ab concentrations = 10 mIU/mL and = 100 mIU/mL
anti-poliovirus types 1, 2, and 3 Ab titers = 1:8
30 days after booster dose of DTwP-HepB-Hib-IPV
Secondary Number of participants reporting immediate adverse events (AEs) Unsolicited (spontaneously reported) systemic AEs Within 30 minutes post-vaccination
Secondary Percentage of participants reporting solicited injection site and systemic reactions Solicited injection site reactions:
- tenderness, erythema, swelling
Solicited systemic reactions:
- fever, vomiting, crying abnormal, drowsiness, appetite lost, irritability
Within 7 days post-vaccination
Secondary Number of participants reporting unsolicited AEs Unsolicited AEs Up to Day 31 post-vaccination
Secondary Number of participants reporting serious adverse events (SAEs) SAEs From Day 1 to Month 18
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