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

NCT05794230
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Phase
Phase 3
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Recruitment status
Completed
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Participants
1,528
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Lead sponsor
Sanofi Pasteur, a Sanofi Company
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Start date
2023-03-27
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Number of sites
15
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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.
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Short title
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
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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
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 3
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Study type
Interventional
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Completion date
2025-11-15
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First posted
2023-04-03
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Registry last updated
2026-01-21
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Primary completion date
2025-11-15
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Start date
2023-03-27
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Actual participants
1,528
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Participants
1,528
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Participant count basis
Actual
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Protocol amendments
6
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Randomisation ratio
1:1
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Number of sites
15
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Sanofi Pasteur, a Sanofi Company
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05794230
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ClinicalTrials.gov ID
NCT05794230
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
No masking
Sources for study design
clinicaltrials.gov

  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

    Timeframe: 30 days after the second vaccination

    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

  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

    Timeframe: 30 days after the booster vaccination

    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

  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

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

    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

  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

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

    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

  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

    Timeframe: Baseline; Before and 30 days after each vaccination

    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

  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

    Timeframe: Baseline; Before and 30 days after each vaccination

    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

  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

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

    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

  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

    Timeframe: Baseline; Before and 30 days after each vaccination

    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

  7. GMCs of Ab against the antigens of age-recommended vaccines in infants and toddlers 6 weeks to 15 months of age

    Timeframe: Baseline

    The following Ab concentrations will be measured: \- Anti-pertussis Ab concentrations (pertussis toxin \[PT\], filamentous hemagglutinin \[FHA\]), fimbriae types 2, 3 \[FIM\], and pertactin \[PRN\])

  8. GMCR of Ab against the antigens of age-recommended vaccines in infants and toddlers 6 weeks to 15 months of age

    Timeframe: Baseline

    The following Ab concentrations will be measured: \- Anti-pertussis Ab concentrations (pertussis toxin \[PT\], filamentous hemagglutinin \[FHA\], fimbriae types 2, 3 \[FIM\], and pertactin \[PRN\])

  9. GMCs/GMTs of Ab against the antigens of age-recommended vaccines in infants and toddlers 6 weeks to 15 months of age

    Timeframe: -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

    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

  10. GMCRs/GMTRs of Ab against the antigens of age-recommended vaccines in infants and toddlers 6 weeks to 15 months of age

    Timeframe: -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

    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

  11. Percentage of participants with Ab concentrations/titers met the predefined criteria in infants and toddlers 6 weeks to 15 months of age

    Timeframe: - 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

    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

  12. Percentage of participants with Ab concentrations/titers met the predefined criteria in infants and toddlers 6 weeks to 15 months of age

    Timeframe: 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

    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)

  13. GMCs/GMTs of Ab against the antigens of age-recommended vaccines in infants and toddlers 6 months to 16 months of age

    Timeframe: 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

    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

  14. GMCRs/GMTRs of Ab against the antigens of age-recommended vaccines in infants and toddlers 6 months to 16 months of age

    Timeframe: 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

    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

  15. Percentage of participants with Ab concentrations/titers met the predefined criteria in infants and toddlers 6 months to 16 months of age

    Timeframe: 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

    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)

  16. GMCs of Ab against the antigens of age-recommended vaccines in infants and toddlers 6 months to 16 months of age

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

    The following Ab concentrations will be measured: \- Anti-pertussis Ab concentrations (pertussis toxin \[PT\], filamentous hemagglutinin \[FHA\], fimbriae types 2, 3 \[FIM\], and pertactin \[PRN\])

  17. GMCR of Ab against the antigens of age-recommended vaccines in infants and toddlers 6 months to 16 months of age

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

    The following Ab concentrations will be measured: \- Anti-pertussis Ab concentrations (pertussis toxin \[PT\], filamentous hemagglutinin \[FHA\], fimbriae types 2, 3 \[FIM\], and pertactin \[PRN\])

  18. Percentage of participants with Ab concentrations/titers met the predefined criteria in infants and toddlers 6 months to 16 months of age

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

    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

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

    Timeframe: Within 30 minutes post-vaccination

    Unsolicited (spontaneously reported) systemic AEs

  20. Percentage of participants reporting solicited injection site and systemic reactions

    Timeframe: Within 7 days post-vaccination

    Solicited injection site reactions: \- tenderness, erythema, swelling Solicited systemic reactions: \- fever, vomiting, crying abnormal, drowsiness, appetite lost, irritability

  21. Number of participants reporting unsolicited AEs

    Timeframe: Up to Day 31 post-vaccination

    Unsolicited AEs

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

    Timeframe: From Day 1 to Month 18

    SAEs

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Children
Minimum age
6 Weeks
Maximum age
6 Months
Healthy volunteers
Yes

  • 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.

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.

Sources for eligibility
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  • Investigational Site Number : 3560006Chennai, India
  • Investigational Site Number : 3560007Hyderabad, India
  • Investigational Site Number : 3560016Kanpur, India
  • Investigational Site Number : 3560009Kolkata, India
  • Investigational Site Number : 3560011Manipal, India
  • Investigational Site Number : 3560013Mysore, India
  • Investigational Site Number : 3560004Mysore, India
  • Investigational Site Number : 3560003New Delhi, India
  • Investigational Site Number : 3560002Pune, India
  • Investigational Site Number : 3560001Pune, India
  • Investigational Site Number : 7100002Cape Town, South Africa
  • Investigational Site Number : 7100003Cape Town, South Africa
  • Investigational Site Number : 7100006George, South Africa
  • Investigational Site Number : 7100005Johannesburg, South Africa
  • Investigational Site Number : 7100001Middelburg, South Africa
Sources for sites
clinicaltrials.gov

Other registry identifiers

  • U1111-1225-0926
Sources for references
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Related records

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