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CompletedNCT05794230Updated Jan 21, 2026

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 interventional study of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine and Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine in Meningococcal Immunisation and Healthy Volunteers, sponsored by Sanofi Pasteur, a Sanofi Company. Completed at 15 sites in 2 countries. Open to participants aged 6 Weeks to 6 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-21.

Sponsored by Sanofi Pasteur, a Sanofi Company · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
1,528
Allocation
Randomized
Ages
6 Weeks to 6 Months
Sex
All
01

Study 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 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.

02

Conditions studied

  • Meningococcal Immunisation
  • Healthy Volunteers
03

In context

Lead sponsor

Sanofi Pasteur, a Sanofi Company is the lead sponsor of 366 studies on the registry; 4 are open to participants now.

Of its 94 completed or terminated interventional studies of FDA-regulated products, 73 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Weeks to 6 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

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
  • 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.

Exclusion criteria

Exclusion Criteria:

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.
  • 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.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,528 participants (actual)

Study arms

  • Experimental
    Groups 1a, 1b and 1c Cohort Ia (India)

    2 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

    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

  • Active comparator
    Group 2 Cohort Ia (India)

    2 injections of Menactra vaccine: at 9 months of age and second dose at 16 months of age + co-administered routine pediatric vaccines

    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

  • Experimental
    Groups 3 Cohort Ib (RSA)

    2 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

    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

  • Active comparator
    Group 4 Cohort Ib (RSA)

    2 injections of Menactra vaccine: at 9 months of age and second dose between 12 and 16 months of age + co-administered routine pediatric vaccines

    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

  • Experimental
    Groups 5a and 5b Cohort IIa (India)

    3 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

    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

  • Other
    Group 6 Cohort IIa (India)

    routine pediatric vaccines only

    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

  • Experimental
    Group 7 Cohort IIb (RSA)

    3 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

    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

  • Other
    Group 8 Cohort IIb (RSA)

    routine pediatric vaccines only

    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

Interventions

  • BiologicalMeningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine

    Liquid solution - intramuscular

    Also known as: MenACYW conjugate vaccine - MenQuadfi™

  • BiologicalMeningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine

    Liquid solution - intramuscular

    Also known as: Menactra®

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

    Oral suspension - oral

    Also known as: BIOPOLIO® B1/3

  • BiologicalPneumoccocal Vaccine

    Suspension for injection - intramuscular

    Also known as: Prevnar 13®

  • BiologicalMeasles, Mumps, and Rubella Vaccine live (MMR)

    Lyophilized powder for injection - subcutaneous

    Also known as: TRESIVAC® PFS

  • BiologicalDTwP-HepB-Hib-IPV vaccine

    Suspension - intramuscular

    Also known as: EasySix™

  • BiologicalDTaP-IPV-Hib-HepB vaccine

    Liquid solution - intramuscular

    Also known as: Hexaxim®

  • BiologicalHepatitis A vaccine

    Lyophilized powder for injection - subcutaneous

    Also known as: Biovac®-A

  • BiologicalRotavirus vaccine

    Oral solution - oral

    Also known as: RotaTeq®

  • BiologicalTyphoid conjugate vaccine (TCV)

    Suspension for injection - intramuscular

    Also known as: Typbar TCV®

  • BiologicalMeasles vaccine

    Freeze-dried powder for reconstitution and injection - subcutaneous

    Also known as: MeasBio®

  • BiologicalVaricella vaccine live

    Sterile powder and diluent for injection - subcutaneous

    Also known as: VARIPED®

  • BiologicalVaricella vaccine live

    Lyophilized powder for injection - subcutaneous

    Also known as: ONVARA®

  • BiologicalMeasles, Mumps, and Rubella Vaccine live (MMR)

    Lyophilized powder for injection - subcutaneous

    Also known as: OMZYTA®

  • BiologicalHepatitis A vaccine

    Suspension for injection - intramuscular

    Also known as: Avaxim® 80 U Pediatric

06

What researchers measure

Primary outcomes

  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

    Time frame: 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

    Time frame: 30 days after the booster vaccination

Secondary outcomes

  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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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 \[PRN\])

    Time frame: 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 \[PRN\])

    Time frame: 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

    Time frame: -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

    Time frame: -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

    Time frame: - 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)

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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 \[PRN\])

    Time frame: 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 \[PRN\])

    Time frame: 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

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

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

    Unsolicited (spontaneously reported) systemic AEs

    Time frame: 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

    Time frame: Within 7 days post-vaccination

  21. Number of participants reporting unsolicited AEs

    Unsolicited AEs

    Time frame: Up to Day 31 post-vaccination

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

    SAEs

    Time frame: From Day 1 to Month 18

07

Study locations

15 sites
  • Investigational Site Number : 3560006
    Chennai, 603203, India
  • Investigational Site Number : 3560007
    Hyderabad, 500018, India
  • Investigational Site Number : 3560016
    Kanpur, 208002, India
  • Investigational Site Number : 3560009
    Kolkata, 700017, India
  • Investigational Site Number : 3560011
    Manipal, 576104, India
  • Investigational Site Number : 3560013
    Mysore, 570001, India
  • Investigational Site Number : 3560004
    Mysore, 570004, India
  • Investigational Site Number : 3560003
    New Delhi, 110002, India
  • Investigational Site Number : 3560002
    Pune, 411011, India
  • Investigational Site Number : 3560001
    Pune, 411043, India
  • Investigational Site Number : 7100002
    Cape Town, 7505, South Africa
  • Investigational Site Number : 7100003
    Cape Town, 7937, South Africa
  • Investigational Site Number : 7100006
    George, 6530, South Africa
  • Investigational Site Number : 7100005
    Johannesburg, 2013, South Africa
  • Investigational Site Number : 7100001
    Middelburg, 1055, South Africa
08

References and documents

Individual participant data

Plan to share: 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

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05794230
Lead sponsor
Sanofi Pasteur, a Sanofi Company
Responsible party
Sponsor
First posted
Apr 3, 2023
Start date
Mar 27, 2023
Primary completion
Nov 15, 2025
Completion
Nov 15, 2025
Last update
Jan 21, 2026

Study contacts

Clinical Sciences & Operations
study director · Sanofi Pasteur, a Sanofi Company

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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