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 (MEQ00064)
November 29, 2023 updated by: Sanofi Pasteur, a Sanofi Company
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
- Biological: Oral bivalent types 1 and 3; Poliomyelitis Vaccine (OPV)
- Biological: Pneumoccocal Vaccine
- Biological: DTaP-IPV-Hib-HepB vaccine
- Biological: Rotavirus vaccine
- Biological: Typhoid conjugate vaccine (TCV)
- Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
- Biological: Measles, Mumps, and Rubella Vaccine live (MMR) - TRESIVAC®
- Biological: DTwP-HepB-Hib-IPV vaccine
- Biological: Hepatitis A vaccine - HAPIBEV™
- Biological: Varicella vaccine live - VARIPED®
- Biological: Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
- Biological: Measles vaccine - MeasBio®
- Biological: Varicella vaccine live - Onvara
- Biological: Measles, Mumps, and Rubella Vaccine live (MMR) - OMZYTA®
- Biological: Hepatitis A vaccine - Avaxim 80 U
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.
Study Type
Interventional
Enrollment (Estimated)
1528
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Trial Transparency email recommended (Toll free number for US & Canada)
- Phone Number: option 6 800-633-1610
- Email: Contact-US@sanofi.com
Study Locations
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Chennai, India, 603203
- Recruiting
- Investigational Site Number : 3560006
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Hyderabad, India, 500018
- Recruiting
- Investigational Site Number : 3560007
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Kanpur, India, 208002
- Recruiting
- Investigational Site Number : 3560016
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Kolkata, India, 700017
- Recruiting
- Investigational Site Number : 3560009
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Manipal, India, 576104
- Recruiting
- Investigational Site Number : 3560011
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Mysore, India, 570001
- Recruiting
- Investigational Site Number : 3560013
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Mysore, India, 570004
- Recruiting
- Investigational Site Number : 3560004
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New Delhi, India, 110002
- Recruiting
- Investigational Site Number : 3560003
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Pune, India, 411011
- Recruiting
- Investigational Site Number : 3560002
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Pune, India, 411043
- Recruiting
- Investigational Site Number : 3560001
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Cape Town, South Africa, 7505
- Recruiting
- Investigational Site Number : 7100002
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Cape Town, South Africa, 7937
- Recruiting
- Investigational Site Number : 7100003
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George, South Africa, 6530
- Recruiting
- Investigational Site Number : 7100006
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Johannesburg, South Africa, 2013
- Recruiting
- Investigational Site Number : 7100005
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Middelburg, South Africa, 1055
- Recruiting
- Investigational Site Number : 7100001
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 6 months (Child)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Cohort I: 6 months of age (180 to 209 days of age) on the day of the first study visit
- Cohort II: 6-8 weeks of age (42 to 62 days of age) on the day of the first study visit
- Healthy infants as determined by medical history, physical examination, and judgment of the Investigator
- Cohort I: Z-score ≥ 2 SD on the Weight-for-age table of the WHO Child Growth Standards.
- Cohort II: Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg.
- Participant and parent/ legally acceptable representative (LAR) are able to attend all scheduled visits and to comply with all study procedures
Exclusion Criteria:
- Participation at the time of study enrollment (or in the 4 weeks preceding the first study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
- Receipt of any vaccine in the 4 weeks preceding the first study vaccination (except for Bacille Calmette-Guérin [BCG], birth dose OPV and birth dose of HepB vaccine) or planned receipt of any vaccine in the 4 weeks following each study vaccination except for the following vaccinations, which may be received at least 2 weeks before or 2 weeks after any study vaccination. This exception includes monovalent pandemic influenza vaccines, multivalent influenza vaccines, any COVID-19 vaccines, and administration of OPV on National Immunization Day in India.
- Previous vaccination against meningococcal disease with either the study vaccine or another vaccine (ie, mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal B serogroup-containing vaccine).
- For Cohort II - Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis (other than birth dose of OPV), Hepatitis A, measles, mumps, rubella, varicella; and of Hib, Streptococcus pneumoniae, and/or RV infection or disease.
- For Cohort II - Previous vaccination with more than 1 dose of HepB vaccine.
- Receipt of immune globulins, blood, or blood-derived products in the past 3 months.
Known or suspected congenital or acquired immunodeficiency*; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
*Note: Participants with a history of HIV but without evident severe immunosuppression can be included.
- Family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
- Individuals with active tuberculosis.
- History of meningococcal infection, confirmed either clinically, serologically, or microbiologically.
- At high risk for meningococcal infection during the study (specifically, but not limited to, participants with persistent complement deficiency, with anatomic or functional asplenia, or participants travelling to countries with high endemic or epidemic disease).
- History of intussusception.
- History of any neurologic disorders, including any seizures and progressive neurologic disorders.
- History of Guillain-Barré syndrome (GBS).
- Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the study or to a vaccine containing any of the same substances, including neomycin, gelatin, and yeast.
- Verbal report of thrombocytopenia, as reported by the parent/LAR, contraindicating IM vaccination in the Investigator's opinion.
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination in the Investigator's opinion.
- Chronic illness (including, but not limited to, cardiac disorders, congenital heart disease, chronic lung disease, renal disorders, auto-immune disorders, diabetes, psychomotor diseases, and known congenital or genetic diseases) that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion.
- Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0 C). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
- Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw.
- Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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
|
Suspension for injection - intramuscular
Other Names:
Oral solution - oral
Other Names:
Suspension for injection - intramuscular
Other Names:
Liquid solution - intramuscular
Other Names:
Lyophilized powder for injection - subcutaneous
Other Names:
Suspension - intramuscular
Other Names:
Suspension for injection - intramuscular
Other Names:
Sterile powder and diluent for injection - subcutaneous
Other Names:
|
|
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
|
Suspension for injection - intramuscular
Other Names:
Oral solution - oral
Other Names:
Suspension for injection - intramuscular
Other Names:
Lyophilized powder for injection - subcutaneous
Other Names:
Suspension - intramuscular
Other Names:
Suspension for injection - intramuscular
Other Names:
Sterile powder and diluent for injection - subcutaneous
Other Names:
Liquid solution - intramuscular
Other Names:
|
|
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
|
Oral suspension - oral
Other Names:
Suspension for injection - intramuscular
Other Names:
Liquid solution - intramuscular
Other Names:
Oral solution - oral
Other Names:
Liquid solution - intramuscular
Other Names:
Freeze-dried powder for reconstitution and injection - subcutaneous
Other Names:
Lyophilized powder for injection - subcutaneous
Other Names:
Lyophilized powder for injection - subcutaneous
Other Names:
Suspension for injection - intramuscular
Other Names:
|
|
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
|
Oral suspension - oral
Other Names:
Suspension for injection - intramuscular
Other Names:
Liquid solution - intramuscular
Other Names:
Oral solution - oral
Other Names:
Liquid solution - intramuscular
Other Names:
Freeze-dried powder for reconstitution and injection - subcutaneous
Other Names:
Lyophilized powder for injection - subcutaneous
Other Names:
Lyophilized powder for injection - subcutaneous
Other Names:
Suspension for injection - intramuscular
Other Names:
|
|
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
|
Suspension for injection - intramuscular
Other Names:
Oral solution - oral
Other Names:
Suspension for injection - intramuscular
Other Names:
Liquid solution - intramuscular
Other Names:
Lyophilized powder for injection - subcutaneous
Other Names:
Suspension - intramuscular
Other Names:
Suspension for injection - intramuscular
Other Names:
Sterile powder and diluent for injection - subcutaneous
Other Names:
|
|
Other: Group 6 Cohort IIa (India)
routine pediatric vaccines only
|
Suspension for injection - intramuscular
Other Names:
Oral solution - oral
Other Names:
Suspension for injection - intramuscular
Other Names:
Lyophilized powder for injection - subcutaneous
Other Names:
Suspension - intramuscular
Other Names:
Suspension for injection - intramuscular
Other Names:
Sterile powder and diluent for injection - subcutaneous
Other Names:
|
|
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
|
Oral suspension - oral
Other Names:
Suspension for injection - intramuscular
Other Names:
Liquid solution - intramuscular
Other Names:
Oral solution - oral
Other Names:
Liquid solution - intramuscular
Other Names:
Freeze-dried powder for reconstitution and injection - subcutaneous
Other Names:
Lyophilized powder for injection - subcutaneous
Other Names:
Lyophilized powder for injection - subcutaneous
Other Names:
Suspension for injection - intramuscular
Other Names:
|
|
Other: Group 8 Cohort IIb (RSA)
routine pediatric vaccines only
|
Oral suspension - oral
Other Names:
Suspension for injection - intramuscular
Other Names:
Liquid solution - intramuscular
Other Names:
Oral solution - oral
Other Names:
Freeze-dried powder for reconstitution and injection - subcutaneous
Other Names:
Lyophilized powder for injection - subcutaneous
Other Names:
Lyophilized powder for injection - subcutaneous
Other Names:
Suspension for injection - intramuscular
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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
|
|
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
Time Frame: 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 |
30 days after the booster vaccination
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
Time Frame: 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
|
Baseline; 30 days after primary series of vaccination; Before and 30 days after booster vaccination
|
|
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
Time Frame: 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
|
Baseline; 30 days after primary series of vaccination; Before and 30 days after booster vaccination
|
|
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
Time Frame: 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
|
Baseline; Before and 30 days after each vaccination
|
|
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
Time Frame: 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
|
Baseline; Before and 30 days after each vaccination
|
|
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
Time Frame: 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
|
Baseline; 30 days after primary series of vaccination; Before and 30 days after booster vaccination
|
|
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
Time Frame: Baseline; Before and 30 days after each vaccination
|
Ab titers after vaccination with MenACYW conjugate vaccine or Menetra® will be measured
|
Baseline; Before and 30 days after each vaccination
|
|
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
Time Frame: Baseline
|
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
|
|
GMCR of Ab against the antigens of age-recommended vaccines in infants and toddlers 6 weeks to 15 months of age
Time Frame: Baseline
|
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
|
|
GMCs/GMTs of Ab against the antigens of age-recommended vaccines in infants and toddlers 6 weeks to 15 months of age
Time Frame: 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
|
The following Ab concentrations/titers will be measured:
|
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
|
|
GMCRs/GMTRs of Ab against the antigens of age-recommended vaccines in infants and toddlers 6 weeks to 15 months of age
Time Frame: 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
|
The following Ab concentrations/titers will be measured:
|
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
|
|
Percentage of participants with Ab concentrations/titers met the predefined criteria in infants and toddlers 6 weeks to 15 months of age
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
|
The following Ab concentrations/titers will be 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
|
|
Percentage of participants with Ab concentrations/titers met the predefined criteria in infants and toddlers 6 weeks to 15 months of age
Time Frame: 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
|
The following Ab concentrations/titers will be measured:
|
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
|
|
GMCs/GMTs of Ab against the antigens of age-recommended vaccines in infants and toddlers 6 months to 16 months of age
Time Frame: 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
|
The following Ab concentrations will be measured:
|
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
|
|
GMCRs/GMTRs of Ab against the antigens of age-recommended vaccines in infants and toddlers 6 months to 16 months of age
Time Frame: 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
|
The following Ab concentrations/titers will be measured:
|
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
|
|
Percentage of participants with Ab concentrations/titers met the predefined criteria in infants and toddlers 6 months to 16 months of age
Time Frame: 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
|
The following Ab concentrations/titers will be measured:
|
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
|
|
GMCs of Ab against the antigens of age-recommended vaccines in infants and toddlers 6 months to 16 months of age
Time Frame: Pre-booster dose vaccination of DTwP-HepB-Hib-IPV
|
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
|
|
GMCR of Ab against the antigens of age-recommended vaccines in infants and toddlers 6 months to 16 months of age
Time Frame: Pre-booster dose vaccination of DTwP-HepB-Hib-IPV
|
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
|
|
Percentage of participants with Ab concentrations/titers met the predefined criteria in infants and toddlers 6 months to 16 months of age
Time Frame: 30 days after booster dose of DTwP-HepB-Hib-IPV
|
The following Ab concentrations/titers will be measured:
|
30 days after booster dose of DTwP-HepB-Hib-IPV
|
|
Number of participants reporting immediate adverse events (AEs)
Time Frame: Within 30 minutes post-vaccination
|
Unsolicited (spontaneously reported) systemic AEs
|
Within 30 minutes post-vaccination
|
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Percentage of participants reporting solicited injection site and systemic reactions
Time Frame: Within 7 days post-vaccination
|
Solicited injection site reactions: - tenderness, erythema, swelling Solicited systemic reactions: - fever, vomiting, crying abnormal, drowsiness, appetite lost, irritability |
Within 7 days post-vaccination
|
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Number of participants reporting unsolicited AEs
Time Frame: Up to Day 31 post-vaccination
|
Unsolicited AEs
|
Up to Day 31 post-vaccination
|
|
Number of participants reporting serious adverse events (SAEs)
Time Frame: From Day 1 to Month 18
|
SAEs
|
From Day 1 to Month 18
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Clinical Sciences & Operations, Sanofi Pasteur, a Sanofi Company
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 27, 2023
Primary Completion (Estimated)
September 8, 2025
Study Completion (Estimated)
September 8, 2025
Study Registration Dates
First Submitted
March 20, 2023
First Submitted That Met QC Criteria
March 20, 2023
First Posted (Actual)
April 3, 2023
Study Record Updates
Last Update Posted (Estimated)
December 5, 2023
Last Update Submitted That Met QC Criteria
November 29, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MEQ00064
- U1111-1225-0926 (Registry Identifier: ICTRP)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy Volunteers
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AstraZenecaCompletedHealthy Elderly Volunteers | Healthy Young VolunteersUnited States
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Syndax PharmaceuticalsCompletedHealthy Volunteers | Volunteers | Normal Volunteers | Human VolunteersUnited States
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Syndax PharmaceuticalsCompletedHealthy Volunteers | Volunteers | Normal Volunteers | Human VolunteersUnited States
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University Hospital, Clermont-FerrandUnite de Nutrition Humaine UMR 1019- INRAE; Unite MetaGenoPolis INRAE; France...CompletedHealthy Volunteers | Frail VolunteersFrance
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Galera Therapeutics, Inc.CelerionCompletedHealthy | Healthy VolunteersUnited States
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Newcastle UniversityCompletedGI Glycaemic Index Healthy Volunteers | GL Glycaemic Load Healthy VolunteersUnited Kingdom
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Galera Therapeutics, Inc.Syneos HealthCompleted
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Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
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Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
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PMV Pharmaceuticals, IncRecruitingHealthy VolunteersUnited States
Clinical Trials on Oral bivalent types 1 and 3; Poliomyelitis Vaccine (OPV)
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PATHBeijing Bio-Institute Biological Products Co., Ltd., formerly Beijing TiantanBioCompleted
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PATHBio Farma, IndonesiaNot yet recruitingPoliomyelitisBangladesh
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Guangxi Zhuang Autonomous Region Center for Disease...Air Force Military Medical University, China; Beijing Tiantan Biological Products...Completed
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Cancer Institute and Hospital, Chinese Academy...Guangxi Center for Disease Control and Prevention; National Institute for the...Completed
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PATHBill and Melinda Gates Foundation; Centers for Disease Control and Prevention; PT Bio Farma and other collaboratorsRecruiting
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Sanofi Pasteur, a Sanofi CompanyCompletedHepatitis B | Pertussis | Tetanus | Diphtheria | InfluenzaPhilippines
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PATHBill and Melinda Gates Foundation; Centers for Disease Control and Prevention; PT Bio Farma and other collaboratorsRecruiting
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Institute of Medical Biology, Chinese Academy of...Guangxi Center for Disease Control and PreventionCompleted
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Tampere UniversityCompletedType 1 Diabetes | Prediabetic State | Enterovirus Infection
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Merck Sharp & Dohme LLCCompletedGastroenteritis | Rotavirus Infections