August 3, 2018
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August 15, 2018
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May 12, 2022
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October 17, 2018
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February 18, 2022 (Final data collection date for primary outcome measure)
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Antibody titers against meningococcal serogroups A, C, Y, and W [ Time Frame: Before the first vaccination and 30 days after the last vaccination in second year of life (Dose 3 of MenACYW conjugate vaccine and Dose 4 of Menveo®) ]
- Meningococcal serogroups A, C, Y, and W antibody titers ≥1:8 measured by hSBA, assessed at 30 days after the last vaccination in the second year of life with MenACYW conjugate vaccine or Menveo® in Mexico (Group 1 and Group 2)
- Meningococcal serogroups A, C, Y, and W antibody titers ≥1:8 measured by hSBA assessed at 30 days after the last vaccination in the second year of life with MenACYW conjugate vaccine in the Russian Federation (Group 3)
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Antibody titers against meningococcal serogroups A, C, Y, and W [ Time Frame: Day 0 (pre-vaccination ) and Day 30 after the last vaccination in second year of life (Dose 3 of MenACYW conjugate vaccine and Dose 4 of Menveo®) ] Titers are measured by serum bactericidal assay using human complement (hSBA), and expressed as geometric mean titers (GMTs)
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- Antibody titers against meningococcal serogroups A, C, Y, and W after infant series vaccination [ Time Frame: Before the first vaccination,30 days after the last vaccination of the infant series and 30 days after the last vaccination in the second year of life (Dose 2 of MenACYW conjugate vaccine and Dose 3 of Menveo®) ]
- Meningococcal serogroups A, C, Y, and W antibody titers measured by hSBA, before the first vaccination (Visit 1) and 30 days after the last vaccination of the infant series and 30 days after the last vaccination in the second year of life with MenACYW conjugate vaccine or Menveo® (Dose 2 of MenACYW conjugate vaccine and Dose 3 of Menveo®) in Mexico (Group 1 and Group 2) (vaccine seroresponse)
- Meningococcal serogroups A, C, Y, and W antibody titers measured by hSBA, before the first vaccination (Visit 1) and 30 days after the last vaccination of the infant series and 30 days after the last vaccination in the second year of life with MenACYW conjugate vaccine (Dose 2 of MenACYW conjugate vaccine) in the Russian Federation (Group 3) (vaccine seroresponse)
- Anti-pertussis (pertussis toxoid [PT], filamentous hemagglutinin [FHA] antibody concentrations (all groups) [ Time Frame: D0 (before the first vaccinations with Hexacima® and RotaTeq®), 30 days after the 12-months vaccinations with M-M-R®II, Prevnar 13®, and Hexacima® ]
- Anti-rotavirus serum IgA antibody concentrations before first vaccination (group 1 and 2) [ Time Frame: D0 (before the first vaccinations with Hexacima® and RotaTeq®) ]
- Anti-pneumococcal antibody concentrations after vaccinations (group 1 and 2) [ Time Frame: 30 days after the 6-months vaccinations with Prevnar 13® and RotaTeq® ]
Anti-pneumococcal antibody concentrations for serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F will be measured
- Anti-rotavirus serum IgA antibody concentrations with ≥ 3-fold and ≥4-fold rise over baseline after vaccinations (group 1 and 2) [ Time Frame: 30 days after the 6-months vaccinations with Prevnar 13® and RotaTeq® ]
- Anti-measles antibody concentrations ≥ 255 mIU/mL after vaccinations (all groups) [ Time Frame: 30 days after the 12-months vaccinations with M-M-R®II, Prevnar 13®, and Hexacima® ]
- Anti-mumps antibody concentrations ≥ 10 mumps antibody units/mL after vaccinations (all groups) [ Time Frame: 30 days after the 12-months vaccinations with M-M-R®II, Prevnar 13®, and Hexacima® ]
- Anti-rubella antibody concentrations ≥ 10 IU/mL after vaccinations (all groups) [ Time Frame: 30 days after the 12-months vaccinations with M-M-R®II, Prevnar 13®, and Hexacima® ]
- Anti-tetanus antibody concentrations ≥ 0.1 IU / mL and 1.0 IU / mL after vaccinations (all groups) [ Time Frame: 30 days after the 6-months vaccinations with Pentaxim® and ENGERIX-B® and the 12-months vaccinations with M-M-R®II, Prevnar 13®, and Hexacima® ]
- Anti-diphtheria antibody concentrations ≥ 0.1 IU / mL and 1.0 IU / mL after vaccinations (all groups) [ Time Frame: 30 days after the 6-months vaccinations with Pentaxim® and ENGERIX-B® and the 12-months vaccinations with M-M-R®II, Prevnar 13®, and Hexacima® ]
- Anti-poliovirus types 1, 2, and 3 antibody titers ≥ 1:8 after vaccinations (all groups) [ Time Frame: 30 days after the 6-months vaccinations with Pentaxim® and ENGERIX-B® and the 12-months vaccinations with M-M-R®II, Prevnar 13®, and Hexacima® ]
- Anti polyribosyl-ribitol phosphate (PRP) antibody concentrations ≥ 0.15 and ≥ 1.0 µg/mL after vaccinations (all groups) [ Time Frame: 30 days after the 6-months vaccinations with Pentaxim® and ENGERIX-B® and the 12-months vaccinations with M-M-R®II, Prevnar 13®, and Hexacima® ]
- IgG antibodies against hepatitis B surface antigen (anti-HB) at concentrations ≥ 10 milli-international units (mIU) / mL and 100 mIU / mL after vaccinations (all groups) [ Time Frame: 30 days after the 6-months vaccinations with Pentaxim® and ENGERIX-B® and the 12-months vaccinations with M-M-R®II, Prevnar 13®, and Hexacima® ]
- hSBA meningococcal serogroups A, C, Y, and W antibody titers (group 1, 2 and 3) [ Time Frame: D0, 30 days after the 6-month vaccination with MenACYW conjugate vaccine and 30 days after the 12-month vaccination with MenACYW or with Menveo ]
- Antibody titers above pre-defined thresholds against meningococcal serogroups A, C, Y, and W measured by hSBA (group 1, 2 and 3) [ Time Frame: D0, 30 days after 6-month vaccination with MenACYW conjugate vaccine (gr 1 and 3) and with Menveo (gr 2) and 30 days after the 12-month vaccination with MenACYW conjugate vaccine or Menveo ]
- Titer distribution and reverse cumulative distribution curves (RCDCs) (group 1, 2 and 3) [ Time Frame: D0, 30 days after 6-month vaccination with MenACYW conjugate vaccine (gr 1 and 3) and with Menveo (gr 2) and 30 days after the 12-month vaccination with MenACYW conjugate vaccine or Menveo ]
- hSBA meningococcal serogroups A, C, Y, and W vaccine seroresponse [ Time Frame: D0, 30 days after 6-month vaccination with MenACYW conjugate vaccine (gr 1 and 3) and with Menveo (gr 2) and 30 days after the 12-month vaccination with MenACYW conjugate vaccine or Menveo ]
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- Antibody titers against meningococcal serogroups A, C, Y, and W after infant series vaccination [ Time Frame: Day 0 (pre-vaccination) and Day 30 after the last vaccination of the infant series (Dose 2 of MenACYW conjugate vaccine and Dose 3 of Menveo®) ]
Titers are expressed as GMTs
- Number of participants with Solicited injection site reactions and systemic reactions [ Time Frame: Within 7 days after any injection ]
Injection site reactions: pain, erythema, and swelling; Systemic reactions: fever, vomiting, crying abnormal, drowsiness, appetite lost, and irritability
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Not Provided
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Not Provided
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Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the Russian Federation and Mexico
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Safety and Immunogenicity of a 3-Dose Schedule of an Investigational Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers
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Primary Objective:
- To describe the vaccine seroprotection (antibody titer≥1:8) to the antigens (meningococcal serogroups A, C, Y, and W) present in MenACYW conjugate vaccine or Menveo® measured by serum bactericidal assay using human complement (hSBA), for Groups 1 and 2 when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers in Mexico
- To describe the vaccine seroprotection (antibody titer≥1:8) to the antigens (meningococcal serogroups A, C, Y, and W) present in MenACYW conjugate vaccine measured by hSBA, for Group 3, when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers in the Russian Federation
Secondary Objective:
- To describe hSBA vaccine seroresponse to the antigens (meningococcal serogroups A, C, Y, and W) 30 days after the last vaccination of the infant series, when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers in Mexico and Russian Federation (RF)
- To describe immunogenicity profile of routine pediatric vaccines when administered concomitantly with MenACYW conjugate vaccine or Menveo®; or when administered alone
- To describe hSBA antibody responses against meningococcal serogroups A, C, Y, and W when MenACYW conjugate vaccine and Menveo® are administered concomitantly with routine pediatric vaccines in Mexico and RF
- To describe antibody titers to the antigens present in MenACYW conjugate vaccine and Menveo®, before the first vaccination and 30 days after the last vaccination of the infant series and in the second year of life, when administered concomitantly with routine pediatric vaccines in a subset of subjects in Mexico and RF
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Study duration per participant is approximately 12 months
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Interventional
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Phase 3
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Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention
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Healthy Volunteers (Meningococcal Infection)
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- Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
Pharmaceutical form: Liquid solution Route of administration : Intramuscular
- Biological: Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine
Pharmaceutical form: Lyophilized powder combined with liquid component Route of administration : Intramuscular
Other Name: Menveo®
- Biological: Measles, Mumps, and Rubella Virus Vaccine Live
Pharmaceutical form: Lyophilized live virus vaccine Route of administration : Subcutaneous
- Biological: Pneumococcal 13-valent Conjugate Vaccine
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Other Name: Prevnar 13®
- Biological: Diphtheria, Tetanus, Pertussis (Acellular, Component) Poliomyelitis (inactivated) Vaccine, and Haemophilus influenza type b Conjugate Vaccine
Pharmaceutical form: Powder and suspension for injection Route of administration: Intramuscular
Other Name: Hexacima®
- Biological: Hepatitis B Vaccine
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Other Name: ENGERIX-B®
- Biological: Rotavirus Vaccine, Live, Pentavalent
Pharmaceutical form: Oral solution Route of administration: Oral
Other Name: RotaTeq®
- Biological: Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated), and Haemophilus influenzae type b conjugate vaccine
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
Other Name: Pentaxim®
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- Experimental: Group 1 (Mexico)
MenACYW conjugate vaccine at 2, 6, and 12 months of age + routine pediatric vaccines at 2, 4, 6, and 12 months of age
Interventions:
- Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
- Biological: Measles, Mumps, and Rubella Virus Vaccine Live
- Biological: Pneumococcal 13-valent Conjugate Vaccine
- Biological: Rotavirus Vaccine, Live, Pentavalent
- Biological: Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated), and Haemophilus influenzae type b conjugate vaccine
- Active Comparator: Group 2 (Mexico)
Menveo® at 2, 4, 6, and 12 months of age + routine pediatric vaccines at 2, 4, 6, and 12 months of age
Interventions:
- Biological: Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine
- Biological: Measles, Mumps, and Rubella Virus Vaccine Live
- Biological: Pneumococcal 13-valent Conjugate Vaccine
- Biological: Rotavirus Vaccine, Live, Pentavalent
- Biological: Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated), and Haemophilus influenzae type b conjugate vaccine
- Experimental: Group 3 (Russian Federation)
MenACYW conjugate vaccine at 3, 6, and 12 months of age + routine pediatric vaccines at 2, 3, 4.5, 6, and 12 months of age
Interventions:
- Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
- Biological: Measles, Mumps, and Rubella Virus Vaccine Live
- Biological: Pneumococcal 13-valent Conjugate Vaccine
- Biological: Diphtheria, Tetanus, Pertussis (Acellular, Component) Poliomyelitis (inactivated) Vaccine, and Haemophilus influenza type b Conjugate Vaccine
- Biological: Hepatitis B Vaccine
- Group 4 (Russian Federation)
Routine pediatric vaccines at 2, 3, 4, 5, 6, and 12 months of age
Interventions:
- Biological: Measles, Mumps, and Rubella Virus Vaccine Live
- Biological: Pneumococcal 13-valent Conjugate Vaccine
- Biological: Diphtheria, Tetanus, Pertussis (Acellular, Component) Poliomyelitis (inactivated) Vaccine, and Haemophilus influenza type b Conjugate Vaccine
- Biological: Hepatitis B Vaccine
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Not Provided
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Completed
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525
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825
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February 18, 2022
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February 18, 2022 (Final data collection date for primary outcome measure)
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Inclusion criteria :
An individual must fulfill all of the following criteria in order to be eligible for trial enrollment:
Exclusion criteria:
An individual fulfilling any of the following criteria is to be excluded from trial enrollment:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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Sexes Eligible for Study: |
All |
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2 Months to 12 Months (Child)
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Yes
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Contact information is only displayed when the study is recruiting subjects
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Mexico, Russian Federation
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NCT03630705
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MET33 U1111-1183-6409 ( Registry Identifier: ICTRP )
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No
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Studies a U.S. FDA-regulated Drug Product: |
Yes |
Studies a U.S. FDA-regulated Device Product: |
No |
Product Manufactured in and Exported from the U.S.: |
Yes |
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Plan to Share IPD: |
Yes |
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 |
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Sanofi ( Sanofi Pasteur, a Sanofi Company )
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Same as current
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Sanofi Pasteur, a Sanofi Company
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Same as current
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Not Provided
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Study Director: |
Clinical Sciences & Operations |
Sanofi |
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Sanofi
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March 2022
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