AzTrials
AzTrials

Meningococcal ImmunisationPhase 3NCT05794230

Study of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Given With Routine Pediatric Vaccines in Healthy Infants and Toddlers in India and the Republic of South Africa

A Phase 3 study testing Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine, Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine and Oral bivalent types 1 and 3; Poliomyelitis Vaccine (OPV) in people with Meningococcal Immunisation and Healthy Volunteers, run by Sanofi Pasteur, a Sanofi Company at 15 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 6 weeks to 6 monthsHealthy volunteers can take part
What is being tested?
Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine, Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine and Oral bivalent types 1 and 3; Poliomyelitis Vaccine (OPV)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,528 participants
Where
15 sitesin 2 countries
Study dates
27 Mar 2023to 15 Nov 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 weeks to 6 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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
  • Participant and parent/ legally acceptable representative (LAR) are able to attend all scheduled visits and to comply with all study procedures
  • 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.

Who cannot join

  • Participants are excluded from the study if any of the following criteria apply:
  • 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.
Show all 23Show fewer
  • 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 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.
  • Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw.
  • 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.
  • Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study.

Trial locations and contacts

15 sites in 2 countries.

15 sites in 2 countries

India10 sites

  • Investigational Site Number : 3560006

    Chennai, 603203

  • Investigational Site Number : 3560007

    Hyderabad, 500018

  • Investigational Site Number : 3560016

    Kanpur, 208002

  • Investigational Site Number : 3560009

    Kolkata, 700017

  • Investigational Site Number : 3560011

    Manipal, 576104

  • Investigational Site Number : 3560013

    Mysore, 570001

  • Investigational Site Number : 3560004

    Mysore, 570004

  • Investigational Site Number : 3560003

    New Delhi, 110002

  • Investigational Site Number : 3560002

    Pune, 411011

  • Investigational Site Number : 3560001

    Pune, 411043

Other trials in India

South Africa5 sites

  • Investigational Site Number : 7100002

    Cape Town, 7505

  • Investigational Site Number : 7100003

    Cape Town, 7937

  • Investigational Site Number : 7100006

    George, 6530

  • Investigational Site Number : 7100005

    Johannesburg, 2013

  • Investigational Site Number : 7100001

    Middelburg, 1055

Other trials in South Africa

About this study

Official title: Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in India and the Republic of South Africa

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:

Read more
  • Cohort I: Infants and toddlers 6 months to 16 months of age (Cohort I)
  • Cohort II: Infants and toddlers 6 weeks to 15 months of age (Cohort II) 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 (Cohort I) 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 (Cohort II) 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 (Cohort II) 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 (Cohort I) 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 (Cohort II) in India and the RSA.
  • in infants and toddlers 6 months to 16 months of age (Cohort I) in India and the RSA.
  • To describe the safety profile of MenACYW conjugate vaccine and that of licensed Menactra vaccine in infants and toddlers 6 months to 16 months of age (Cohort I) in India and the RSA when administered concomitantly with other age-recommended vaccines.
  • To describe the safety profile of MenACYW conjugate vaccine in infants and toddlers 6 weeks to 15 months of age (Cohort II) in India and the RSA when administered concomitantly with other age-recommended vaccines.
  • To describe the safety profile of age-recommended vaccines:
  • in infants 6 weeks to 15 months of age (Cohort II) in India and the RSA when administered concomitantly with MenACYW conjugate vaccine.
  • in infants and toddlers 6 months to 16 months of age (Cohort I) in India and the RSA when administered concomitantly with MenACYW conjugate vaccine.

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.

Read the detailed 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.

Being tested
Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine, Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine, Oral bivalent types 1 and 3; Poliomyelitis Vaccine (OPV), Pneumoccocal Vaccine, Measles, Mumps, and Rubella Vaccine live (MMR)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate VaccineBiological

    Also called MenACYW conjugate vaccine - MenQuadfi™

    Liquid solution - intramuscular

  • Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate VaccineBiological

    Also called Menactra®

    Liquid solution - intramuscular

  • Oral bivalent types 1 and 3; Poliomyelitis Vaccine (OPV)Biological

    Also called BIOPOLIO® B1/3

    Oral suspension - oral

  • Pneumoccocal VaccineBiological

    Also called Prevnar 13®

    Suspension for injection - intramuscular

  • Measles, Mumps, and Rubella Vaccine live (MMR)Biological

    Also called TRESIVAC® PFS

    Lyophilized powder for injection - subcutaneous

  • DTwP-HepB-Hib-IPV vaccineBiological

    Also called EasySix™

    Suspension - intramuscular

  • DTaP-IPV-Hib-HepB vaccineBiological

    Also called Hexaxim®

    Liquid solution - intramuscular

  • Hepatitis A vaccineBiological

    Also called Biovac®-A

    Lyophilized powder for injection - subcutaneous

  • Rotavirus vaccineBiological

    Also called RotaTeq®

    Oral solution - oral

  • Typhoid conjugate vaccine (TCV)Biological

    Also called Typbar TCV®

    Suspension for injection - intramuscular

  • Measles vaccineBiological

    Also called MeasBio®

    Freeze-dried powder for reconstitution and injection - subcutaneous

  • Varicella vaccine liveBiological

    Also called VARIPED®

    Sterile powder and diluent for injection - subcutaneous

  • Varicella vaccine liveBiological

    Also called ONVARA®

    Lyophilized powder for injection - subcutaneous

  • Measles, Mumps, and Rubella Vaccine live (MMR)Biological

    Also called OMZYTA®

    Lyophilized powder for injection - subcutaneous

  • Hepatitis A vaccineBiological

    Also called Avaxim® 80 U Pediatric

    Suspension for injection - intramuscular

Study groups in NCT05794230
Study groupRoleWhat they receive
Groups 1a, 1b and 1c Cohort Ia (India)Experimental2 injections of MenACYW conjugate vaccine: at 6 months of age and second dose at 12 months of age (group 1a) or at 15 months of age (group 1b) or at 16 months of age (group 1c) + co-administered routine pediatric vaccines
Receives: Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine; Biological: Pneumoccocal Vaccine; Biological: Measles, Mumps, and Rubella Vaccine live (MMR); Biological: DTwP-HepB-Hib-IPV vaccine; Biological: Hepatitis A vaccine; Biological: Rotavirus vaccine; Biological: Typhoid conjugate vaccine (TCV); Biological: Varicella vaccine live
Group 2 Cohort Ia (India)Active comparator2 injections of Menactra vaccine: at 9 months of age and second dose at 16 months of age + co-administered routine pediatric vaccines
Receives: Biological: Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine; Biological: Pneumoccocal Vaccine; Biological: Measles, Mumps, and Rubella Vaccine live (MMR); Biological: DTwP-HepB-Hib-IPV vaccine; Biological: Hepatitis A vaccine; Biological: Rotavirus vaccine; Biological: Typhoid conjugate vaccine (TCV); Biological: Varicella vaccine live
Groups 3 Cohort Ib (RSA)Experimental2 injections of MenACYW conjugate vaccine: at 6 months of age and second dose between 12 and 16 months of age + co-administered routine pediatric vaccines
Receives: Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine; Biological: Oral bivalent types 1 and 3; Poliomyelitis Vaccine (OPV); Biological: Pneumoccocal Vaccine; Biological: DTaP-IPV-Hib-HepB vaccine; Biological: Rotavirus vaccine; Biological: Measles vaccine; Biological: Varicella vaccine live; Biological: Measles, Mumps, and Rubella Vaccine live (MMR); Biological: Hepatitis A vaccine
Group 4 Cohort Ib (RSA)Active comparator2 injections of Menactra vaccine: at 9 months of age and second dose between 12 and 16 months of age + co-administered routine pediatric vaccines
Receives: Biological: Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine; Biological: Oral bivalent types 1 and 3; Poliomyelitis Vaccine (OPV); Biological: Pneumoccocal Vaccine; Biological: DTaP-IPV-Hib-HepB vaccine; Biological: Rotavirus vaccine; Biological: Measles vaccine; Biological: Varicella vaccine live; Biological: Measles, Mumps, and Rubella Vaccine live (MMR); Biological: Hepatitis A vaccine
Groups 5a and 5b Cohort IIa (India)Experimental3 injections of MenACYW conjugate vaccine: at 6-8 weeks of age and second dose at 14-16 weeks of age with a booster dose administered at 12 months of age (group 5a) or at 15 months of age (group 5b) + co-administered routine pediatric vaccines
Receives: Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine; Biological: Pneumoccocal Vaccine; Biological: Measles, Mumps, and Rubella Vaccine live (MMR); Biological: DTwP-HepB-Hib-IPV vaccine; Biological: Hepatitis A vaccine; Biological: Rotavirus vaccine; Biological: Typhoid conjugate vaccine (TCV); Biological: Varicella vaccine live
Group 6 Cohort IIa (India)Otherroutine pediatric vaccines only
Receives: Biological: Pneumoccocal Vaccine; Biological: Measles, Mumps, and Rubella Vaccine live (MMR); Biological: DTwP-HepB-Hib-IPV vaccine; Biological: Hepatitis A vaccine; Biological: Rotavirus vaccine; Biological: Typhoid conjugate vaccine (TCV); Biological: Varicella vaccine live
Group 7 Cohort IIb (RSA)Experimental3 injections of MenACYW conjugate vaccine: at 6-8 weeks of age and second dose at 14-16 weeks of age with a booster dose administered between 12 and 15 months of age + co-administered routine pediatric vaccines
Receives: Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine; Biological: Oral bivalent types 1 and 3; Poliomyelitis Vaccine (OPV); Biological: Pneumoccocal Vaccine; Biological: DTaP-IPV-Hib-HepB vaccine; Biological: Rotavirus vaccine; Biological: Measles vaccine; Biological: Varicella vaccine live; Biological: Measles, Mumps, and Rubella Vaccine live (MMR); Biological: Hepatitis A vaccine
Group 8 Cohort IIb (RSA)Otherroutine pediatric vaccines only
Receives: Biological: Oral bivalent types 1 and 3; Poliomyelitis Vaccine (OPV); Biological: Pneumoccocal Vaccine; Biological: DTaP-IPV-Hib-HepB vaccine; Biological: Rotavirus vaccine; Biological: Measles vaccine; Biological: Varicella vaccine live; Biological: Measles, Mumps, and Rubella Vaccine live (MMR); Biological: Hepatitis A vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 30 days after the second vaccination

  2. 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

    Measured: 30 days after the booster vaccination

Secondary outcomes (22)

  1. 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

    Measured: Baseline; 30 days after primary series of vaccination; Before and 30 days after booster vaccination

  2. 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

    Measured: Baseline; 30 days after primary series of vaccination; Before and 30 days after booster vaccination

  3. 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

    Measured: Baseline; Before and 30 days after each vaccination

  4. 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

    Measured: Baseline; Before and 30 days after each vaccination

  5. 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

    Measured: Baseline; 30 days after primary series of vaccination; Before and 30 days after booster vaccination

  6. 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

    Measured: Baseline; Before and 30 days after each vaccination

  7. GMCs 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 toxin [PT], filamentous hemagglutinin [FHA]), fimbriae types 2, 3 [FIM], and pertactin [PRN])

    Measured: Baseline

  8. 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 toxin [PT], filamentous hemagglutinin [FHA], fimbriae types 2, 3 [FIM], and pertactin [PRN])

    Measured: Baseline

  9. 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

    Measured: -30 days after:-Dose3 of DTwP-HepB-Hib-IPV/DTaP-IPV-Hib-HepB;-1ry series of PCV13;-measles,mumps & rubella: Dose1 in RSA;Dose2 in India;-1st dose of varicella vaccine -30 days at least after booster dose of PCV13 -Before & 30 days after 1ry series of RV

  10. 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

    Measured: -30days after:-1ry series of DTwP-HepB-Hib-IPV/DTaP-IPV-Hib-HepB;-1ry series of PCV13;-measles,mumps & rubella:Dose1 in RSA;Dose2 in India;-1st dose of varicella vaccine -30days at least after booster dose of PCV13 -Before&30 days after 1ry series of RV

  11. 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), ≥ 0.1 IU/mL and > 1.0 IU/mL
    • Anti-diphtheria Ab ≥ 0.01 IU/mL, ≥ 0.1 IU/mL and > 1.0 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 and ≥ 1.0 μg/mL

    Measured: - 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

  12. 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)

    Measured: 30 days after: - Primary series of RV - Dose 1 of measles, mumps and rubella in RSA - Dose 2 of measles, mumps and rubella in India - first dose of varicella vaccine

  13. 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

    Measured: 30 days after: - first dose of varicella vaccine - the booster dose of PCV13 - Dose 1 of measles, mumps and rubella in RSA - Dose 2 of measles, mumps and rubella in India - after booster dose of DTwP-HepB-Hib-IPV

  14. 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

    Measured: 30 days after: - first dose of varicella vaccine - the booster dose of PCV13 - Dose 1 of measles, mumps and rubella in RSA - Dose 2 of measles, mumps and rubella in India - after booster dose of DTwP-HepB-Hib-IPV

  15. 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 and ≥ 1.0 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)

    Measured: 30 days after: - the booster dose of PCV13 - Dose 1 of measles, mumps and rubella in RSA - Dose 2 of measles, mumps and rubella in India - first dose of varicella vaccine

  16. 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 toxin [PT], filamentous hemagglutinin [FHA], fimbriae types 2, 3 [FIM], and pertactin [PRN])

    Measured: Pre-booster dose vaccination of DTwP-HepB-Hib-IPV

  17. 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 toxin [PT], filamentous hemagglutinin [FHA], fimbriae types 2, 3 [FIM], and pertactin [PRN])

    Measured: Pre-booster dose vaccination of DTwP-HepB-Hib-IPV

  18. 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

    Measured: 30 days after booster dose of DTwP-HepB-Hib-IPV

  19. Number of participants reporting immediate adverse events (AEs)

    Unsolicited (spontaneously reported) systemic AEs

    Measured: Within 30 minutes post-vaccination

  20. 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

    Measured: Within 7 days post-vaccination

  21. Number of participants reporting unsolicited AEs

    Unsolicited AEs

    Measured: Up to Day 31 post-vaccination

  22. Number of participants reporting serious adverse events (SAEs)

    SAEs

    Measured: From Day 1 to Month 18

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2023
  2. Study start27 Mar 2023
  3. Primary completion15 Nov 2025
  4. Study completion15 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Cohort I: Infants and toddlers 6 months to 16 months of age. Eligible participants are randomized in a 1:1 ratio to receive 2 injections of either MenACYW conjugate vaccine (Groups 1 and 3) or Menactra vaccine (Groups 2 and 4), co-administered with routine pediatric vaccines. Cohort II: Infants and toddlers 6 weeks to 15 months of age. Eligible participants are randomized in a 2:1 ratio to receive either 3 injections of MenACYW conjugate vaccine co-administered with routine pediatric vaccines (Groups 5 and 7), or routine pediatric vaccines only (Groups 6 and 8).
Masking
None (open label)
Enrolment
1,528 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05794230
Sponsor's protocol ID
MEQ00064
Other IDs
U1111-1225-0926
Status last verified
Jan 2026
First submitted
20 Mar 2023
Last updated
21 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine, Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine and Oral bivalent types 1 and 3; Poliomyelitis Vaccine (OPV) in people with Meningococcal Immunisation and Healthy Volunteers, run by Sanofi Pasteur, a Sanofi Company at 15 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in India, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 30 days after the second vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05794230.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.

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