Healthy Volunteers Clinical Trial
— MEQ00064Official 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: - Cohort I: Infants and toddlers 6 months to 16 months of age - Cohort II: Infants and toddlers 6 weeks to 15 months of age In Cohort I, eligible participants will be randomized in a 1:1 ratio to receive 2 intramuscular (IM) injections (1+1 vaccination schedule) of either MenACYW conjugate vaccine (Groups 1 and 3) or Menactra vaccine (Groups 2 and 4), co-administered with routine pediatric vaccines. In Cohort II, eligible participants will be randomized in a 2:1 ratio to receive either 3 IM injections (2+1 vaccination schedule) of MenACYW conjugate vaccine co-administered with routine pediatric vaccines (Groups 5 and 7) or routine pediatric vaccines only (Groups 6 and 8). The primary objectives of this study are: - To demonstrate the non-inferiority of immunogenicity of 2 doses of MenACYW conjugate vaccine compared to 2 doses of Menactra® vaccine in infants and toddlers 6 months to 16 months of age in terms of serum bactericidal assay using human complement (hSBA) seroprotection (titers ≥ 1:8) in India and the Republic of South Africa (RSA) - To demonstrate the vaccine immune sufficiency of 3 doses of MenACYW conjugate vaccine in infants and toddlers 6 weeks to 15 months of age in terms of hSBA seroprotection (titers ≥ 1:8) in India and the RSA The secondary objectives of this study are: - To describe the antibody titers to the meningococcal serogroups A, C, Y, and W: - before and 30 days post primary series of MenACYW conjugate vaccine and before and 30 days post booster dose of MenACYW conjugate vaccine in infants and toddlers 6 weeks to 15 months of age in India and the RSA when administered concomitantly with other age-recommended vaccines. - before and after 30 days post each dose of MenACYW conjugate vaccine or Menactra vaccine in infants and toddlers 6 months to 16 months of age in India and the RSA when administered concomitantly with other age-recommended vaccines. - To describe the antibody responses against the antigens of the other age-recommended vaccines when administered concomitantly with MenACYW conjugate vaccine: - in infants and toddlers 6 weeks to 15 months of age in India and the RSA. - in infants and toddlers 6 months to 16 months of age in India and the RSA. The duration of each participant's active participation in the study will be approximately 10 to 11 months for Cohort I and 13,5 to 14,5 months for Cohort II.
| Status | Recruiting |
| Enrollment | 1528 |
| Est. completion date | September 8, 2025 |
| Est. primary completion date | September 8, 2025 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 6 Weeks to 6 Months |
| Eligibility | Inclusion Criteria: - Cohort I: 6 months of age (180 to 209 days of age) on the day of the first study visit - Cohort II: 6-8 weeks of age (42 to 62 days of age) on the day of the first study visit - Healthy infants as determined by medical history, physical examination, and judgment of the Investigator - Cohort I: Z-score = 2 SD on the Weight-for-age table of the WHO Child Growth Standards. - Cohort II: Born at full term of pregnancy (= 37 weeks) and with a birth weight = 2.5 kg. - Participant and parent/ legally acceptable representative (LAR) are able to attend all scheduled visits and to comply with all study procedures Exclusion Criteria: - Participation at the time of study enrollment (or in the 4 weeks preceding the first study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure. - Receipt of any vaccine in the 4 weeks preceding the first study vaccination (except for Bacille Calmette-Guérin [BCG], birth dose OPV and birth dose of HepB vaccine) or planned receipt of any vaccine in the 4 weeks following each study vaccination except for the following vaccinations, which may be received at least 2 weeks before or 2 weeks after any study vaccination. This exception includes monovalent pandemic influenza vaccines, multivalent influenza vaccines, any COVID-19 vaccines, and administration of OPV on National Immunization Day in India. - Previous vaccination against meningococcal disease with either the study vaccine or another vaccine (ie, mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal B serogroup-containing vaccine). - For Cohort II - Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis (other than birth dose of OPV), Hepatitis A, measles, mumps, rubella, varicella; and of Hib, Streptococcus pneumoniae, and/or RV infection or disease. - For Cohort II - Previous vaccination with more than 1 dose of HepB vaccine. - Receipt of immune globulins, blood, or blood-derived products in the past 3 months. - Known or suspected congenital or acquired immunodeficiency*; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months). *Note: Participants with a history of HIV but without evident severe immunosuppression can be included. - Family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated. - Individuals with active tuberculosis. - History of meningococcal infection, confirmed either clinically, serologically, or microbiologically. - At high risk for meningococcal infection during the study (specifically, but not limited to, participants with persistent complement deficiency, with anatomic or functional asplenia, or participants travelling to countries with high endemic or epidemic disease). - History of intussusception. - History of any neurologic disorders, including any seizures and progressive neurologic disorders. - History of Guillain-Barré syndrome (GBS). - Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the study or to a vaccine containing any of the same substances, including neomycin, gelatin, and yeast. - Verbal report of thrombocytopenia, as reported by the parent/LAR, contraindicating IM vaccination in the Investigator's opinion. - Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination in the Investigator's opinion. - Chronic illness (including, but not limited to, cardiac disorders, congenital heart disease, chronic lung disease, renal disorders, auto-immune disorders, diabetes, psychomotor diseases, and known congenital or genetic diseases) that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion. - Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature = 38.0 C). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided. - Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw. - Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study. |
| Country | Name | City | State |
|---|---|---|---|
| India | Investigational Site Number : 3560006 | Chennai | |
| India | Investigational Site Number : 3560007 | Hyderabad | |
| India | Investigational Site Number : 3560016 | Kanpur | |
| India | Investigational Site Number : 3560009 | Kolkata | |
| India | Investigational Site Number : 3560011 | Manipal | |
| India | Investigational Site Number : 3560004 | Mysore | |
| India | Investigational Site Number : 3560013 | Mysore | |
| India | Investigational Site Number : 3560003 | New Delhi | |
| India | Investigational Site Number : 3560001 | Pune | |
| India | Investigational Site Number : 3560002 | Pune | |
| South Africa | Investigational Site Number : 7100002 | Cape Town | |
| South Africa | Investigational Site Number : 7100003 | Cape Town | |
| South Africa | Investigational Site Number : 7100006 | George | |
| South Africa | Investigational Site Number : 7100005 | Johannesburg | |
| South Africa | Investigational Site Number : 7100001 | Middelburg |
| Lead Sponsor | Collaborator |
|---|---|
| Sanofi Pasteur, a Sanofi Company |
India, South Africa,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of participants with anti-meningococcal serogroups A, C, Y, W antibody titers above predefined thresholds after 2 doses of MenACYW conjugate vaccine compared to 2 doses of Menactra® vaccine in infants and toddlers 6 months to 16 months of age | Antibody (Ab) titers against meningococcal serogroups A, C, Y, and W will be measured in infants and toddlers 6 months to 16 months of age ([Group 1 + Group 3] versus [Group 2 + Group 4])
The following threshold values will be considered: = 1:8 |
30 days after the second vaccination | |
| Primary | Percentage of participants with anti-meningococcal serogroups A, C, Y, W Ab titers above predefined thresholds after 3 doses of MenACYW conjugate vaccine in infants and toddlers 6 weeks to 15 months of age | Ab titers against meningococcal serogroups A, C, Y, and W will be measured in infants and toddlers 6 months to 15 months of age (Group 5 + Group 7)
The following threshold values will be considered: = 1:8 |
30 days after the booster vaccination | |
| Secondary | Geometric Mean Titers (GMTs) of Ab against meningococcal serogroups A, C, Y, and W when MenACYW conjugate vaccine administered concomitantly with other age-recommended vaccine in infants 6 weeks to 15 months of age | Ab titers against meningococcal serogroups A, C, Y, and W will be measured Group 5 versus Group 6 in India Group 7 versus Group 8 in RSA Group 5 + Group 7 versus Group 6 + Group 8 | Baseline; 30 days after primary series of vaccination; Before and 30 days after booster vaccination | |
| Secondary | Geometric Mean Titers Ratio (GMTR) of Ab against meningococcal serogroups A, C, Y, and W when MenACYW conjugate vaccine administered concomitantly with other age-recommended vaccine in infants 6 weeks to 15 months of age | Ab titers against meningococcal serogroups A, C, Y, and W will be measured Group 5 versus Group 6 in India Group 7 versus Group 8 in RSA Group 5 + Group 7 versus Group 6 + Group 8 | Baseline; 30 days after primary series of vaccination; Before and 30 days after booster vaccination | |
| Secondary | GMTs of Ab against meningococcal serogroups A, C, Y, and W when MenACYW conjugate vaccine or Menactra vaccine when administered concomitantly with other age-recommended vaccines in infants and toddlers 6 months to 16 months of age | Ab titers after vaccination with MenACYW conjugate vaccine or Menetra® will be measured Group 1 versus Group 2 in India Group 3 versus Group 4 in the RSA Group 1 + Group 3 versus Group 2 + Group 4 | Baseline; Before and 30 days after each vaccination | |
| Secondary | GMTR of Ab against meningococcal serogroups A, C, Y, and W when MenACYW conjugate vaccine or Menactra vaccine when administered concomitantly with other age-recommended vaccines in infants and toddlers 6 months to 16 months of age | Ab titers after vaccination with MenACYW conjugate vaccine or Menetra® will be measured Group 1 versus Group 2 in India Group 3 versus Group 4 in the RSA Group 1 + Group 3 versus Group 2 + Group 4 | Baseline; Before and 30 days after each vaccination | |
| Secondary | Percentage of participants with anti-meningococcal serogroups A, C, Y, and W Ab titers met the predefined criteria when MenACYW conjugate vaccine administered concomitantly with other age-recommended vaccine in infants 6 weeks to 15 months of age | Ab titers against meningococcal serogroups A, C, Y, and W will be measured
hSBA titer = 1:4 and = 1:8 hSBA titer = 4-fold rise from pre-vaccination to post-vaccination hSBA vaccine seroresponse |
Baseline; 30 days after primary series of vaccination; Before and 30 days after booster vaccination | |
| Secondary | Percentage of participants with anti-meningococcal serogroups A, C, Y, and W Ab titers met the predefined criteria when MenACYW conjugate vaccine administered concomitantly with other age-recommended vaccine in infants and toddlers 6 to 16 months of age | Ab titers after vaccination with MenACYW conjugate vaccine or Menetra® will be measured
hSBA titer = 1:4 and = 1:8 hSBA titer = 4-fold rise from pre-vaccination to post-vaccination hSBA vaccine seroresponse |
Baseline; Before and 30 days after each vaccination | |
| Secondary | GMCs of Ab against the antigens of age-recommended vaccines in infants and toddlers 6 weeks to 15 months of age GMCR of Ab against the antigens of age-recommended vaccines in infants and toddlers 6 weeks to 15 months of age | The following Ab concentrations will be measured:
- Anti-pertussis Ab concentrations (pertussis toxoid [PT], filamentous hemagglutinin [FHA]), fimbriae types 2, 3 [FIM], and pertactin [PRN]) |
Baseline | |
| Secondary | GMCR of Ab against the antigens of age-recommended vaccines in infants and toddlers 6 weeks to 15 months of age | The following Ab concentrations will be measured:
- Anti-pertussis Ab concentrations (pertussis toxoid [PT], filamentous hemagglutinin [FHA], fimbriae types 2, 3 [FIM], and pertactin [PRN]) |
Baseline | |
| Secondary | GMCs/GMTs of Ab against the antigens of age-recommended vaccines in infants and toddlers 6 weeks to 15 months of age | The following Ab concentrations/titers will be measured:
against the antigens of DTwP-HepB-Hib/DTaP-IPV-Hib-HepB against the antigens of PCV13 against the antigens of RV (serum RV immunoglobulin [Ig]A) against the antigens of measles, mumps and rubella against the antigens of varicella vaccine |
30 days after: -Dose 3 of DTwP-HepB-Hib-IPV/DTaP-IPV-Hib-HepB -primary series of PCV13 -booster dose of PCV13 -Dose 2 of measles, mumps and rubella (after Dose 1 in RSA) -first dose of varicella vaccine; Before and 30 days after primary series of RV | |
| Secondary | GMCRs/GMTRs of Ab against the antigens of age-recommended vaccines in infants and toddlers 6 weeks to 15 months of age | The following Ab concentrations/titers will be measured:
against the antigens of DTwP-HepB-Hib-IPV/DTaP-IPV-Hib-HepB against the antigens of PCV13 against the antigens of RV (serum RV immunoglobulin [Ig]A) against the antigens of measles, mumps and rubella against the antigens of varicella vaccine |
30days after-primary series of DTwP-HepB-Hib-IPV/DTaP-IPV-Hib-HepB-primary series of PCV13 -Dose2 of measles,mumps,rubella(after Dose1 in RSA)-Dose1 of varicella vaccine;30days at least after booster dose of PCV13;Before&30days after primary series of RV | |
| Secondary | Percentage of participants with Ab concentrations/titers met the predefined criteria in infants and toddlers 6 weeks to 15 months of age | The following Ab concentrations/titers will be measured:
Anti-tetanus Ab = 0.01 International Units (IU)/milliliter (mL) and = 0.1 IU/mL Anti-diphtheria Ab = 0.01 IU/mL and = 0.1 IU/mL Anti-polyribosyl-ribitol phosphate (PRP) Ab = 0.15 micrograms (µg)/mL and = 1.0 µg/mL Pertussis vaccine seroresponse for anti-PT, and anti-PT, anti-FHA, anti-FIM, and anti-PRN Anti-hepatitis B surface antigen (HBsAg) Ab = 10 mIU/mL and = 100 mIU/mL Anti-poliovirus types 1, 2, and 3 Ab titers = 1:8 Anti-pneumococcal Ab = 0.35 µg/mL |
- 30 days after dose 3 of DTwP-HepB-Hib/DTaP-IPV-Hib-HepB - 30 days after primary series of PCV13 and 30 days after the booster dose of PCV13 | |
| Secondary | Percentage of participants with Ab concentrations/titers met the predefined criteria in infants and toddlers 6 weeks to 15 months of age | The following Ab concentrations/titers will be measured:
Anti-RV seroresponse Anti-measles Ab concentrations (serostatus cutoff: 255 mIU/mL) Anti-mumps Ab concentrations (serostatus cutoff: 10 Mumps antibody units/mL) Anti-rubella Ab concentrations (serostatus cutoff: 10 IU/mL) Anti-varicella Ab concentrations (serostatus cutoff: 5gpELISA unit/mL) |
30 days after: -primary series of RV -Dose 2 of measles, mumps and rubella (after Dose 1 in the RSA) -first dose of varicella vaccine | |
| Secondary | GMCs/GMTs of Ab against the antigens of age-recommended vaccines in infants and toddlers 6 months to 16 months of age | The following Ab concentrations will be measured:
against the antigens of varicella against the antigens of PCV13 against the antigens of measles, mumps and rubella against the antigens of DTwP-HepB-Hib-IPV |
30 days after:-first dose of varicella vaccine -the booster dose of PCV13 -after Dose 2 of measles, mumps and rubella (after Dose 1 in the RSA) -after booster dose of DTwP-HepB-Hib-IPV | |
| Secondary | GMCRs/GMTRs of Ab against the antigens of age-recommended vaccines in infants and toddlers 6 months to 16 months of age | The following Ab concentrations/titers will be measured:
against the antigen of varicella against the antigens of PCV13 against the antigens of measles, mumps and rubella against the antigens of DTwP-HepB-Hib-IPV |
30 days after:-first dose of varicella vaccine -the booster dose of PCV13 -after Dose 2 of measles, mumps and rubella (after Dose 1 in the RSA -after booster dose of DTwP-HepB-Hib-IPV | |
| Secondary | Percentage of participants with Ab concentrations/titers met the predefined criteria in infants and toddlers 6 months to 16 months of age | The following Ab concentrations/titers will be measured:
anti-pneumococcal Ab concentrations = 0.35 µg/mL anti-measles Ab concentrations (serostatus cutoff: 255 mIU/mL) anti-mumps Ab concentrations (serostatus cutoff: 10 Mumps antibody units/mL) anti-rubella Ab concentrations (serostatus cutoff: 10 IU/mL) anti-varicella Ab concentrations (serostatus cutoff: 5gpELISA unit/mL) |
30 days after :-the booster dose of PCV13 -Dose 2 of measles, mumps and rubella (after Dose 1 in the RSA) -first dose of varicella vaccine | |
| Secondary | GMCs of Ab against the antigens of age-recommended vaccines in infants and toddlers 6 months to 16 months of age | The following Ab concentrations will be measured:
- Anti-pertussis Ab concentrations (pertussis toxoid [PT], filamentous hemagglutinin [FHA], fimbriae types 2, 3 [FIM], and pertactin [PRN]) |
Pre-booster dose vaccination of DTwP-HepB-Hib-IPV | |
| Secondary | GMCR of Ab against the antigens of age-recommended vaccines in infants and toddlers 6 months to 16 months of age | The following Ab concentrations will be measured:
- Anti-pertussis Ab concentrations (pertussis toxoid [PT], filamentous hemagglutinin [FHA], fimbriae types 2, 3 [FIM], and pertactin [PRN]) |
Pre-booster dose vaccination of DTwP-HepB-Hib-IPV | |
| Secondary | Percentage of participants with Ab concentrations/titers met the predefined criteria in infants and toddlers 6 months to 16 months of age | The following Ab concentrations/titers will be measured:
anti-tetanus Ab concentrations = 0.01 IU/mL, = 0.1 IU/mL and = 1.0 IU/mL anti-diphtheria Ab concentrations = 0.01 IU/mL, and = 0.1 IU/mL anti-PRP Ab concentrations = 0.15 µg)/mL and = 1.0 µg/mL pertussis vaccine seroresponse for anti-PT, anti-FHA, anti-FIM, and anti-PRN anti-HBsAg Ab concentrations = 10 mIU/mL and = 100 mIU/mL anti-poliovirus types 1, 2, and 3 Ab titers = 1:8 |
30 days after booster dose of DTwP-HepB-Hib-IPV | |
| Secondary | Number of participants reporting immediate adverse events (AEs) | Unsolicited (spontaneously reported) systemic AEs | Within 30 minutes post-vaccination | |
| Secondary | Percentage of participants reporting solicited injection site and systemic reactions | Solicited injection site reactions:
- tenderness, erythema, swelling Solicited systemic reactions: - fever, vomiting, crying abnormal, drowsiness, appetite lost, irritability |
Within 7 days post-vaccination | |
| Secondary | Number of participants reporting unsolicited AEs | Unsolicited AEs | Up to Day 31 post-vaccination | |
| Secondary | Number of participants reporting serious adverse events (SAEs) | SAEs | From Day 1 to Month 18 |
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