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
MET33
2 other identifiers
interventional
525
2 countries
11
Brief Summary
Primary Objective:
- 1.To describe the vaccine seroprotection (antibody titer greater than or equal to \[\>=\] 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.
- 2.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.
- 3.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).
- 4.To describe immunogenicity profile of routine pediatric vaccines when administered concomitantly with MenACYW Conjugate vaccine or Menveo®; or when administered alone.
- 5.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.
- 6.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 participants in Mexico and RF.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2018
Typical duration for phase_3
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2018
CompletedFirst Posted
Study publicly available on registry
August 15, 2018
CompletedStudy Start
First participant enrolled
October 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 18, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 18, 2022
CompletedResults Posted
Study results publicly available
October 19, 2023
CompletedOctober 19, 2023
September 1, 2023
3.3 years
August 3, 2018
September 6, 2023
September 26, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 1:8 Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by serum bactericidal assay using human complement (hSBA) assay. Group 3 data were presented separately.
30 days after the last vaccination at the age of 12 months (i.e., at the age of 13 months)
Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate Vaccine: Group 3
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay.
30 days after the last vaccination at the age of 12 months (i.e., at the age of 13 months)
Secondary Outcomes (44)
Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
30 days after the last vaccination at the age of 6 months of the infant series (i.e., at the age of 7 months)
Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate Vaccine: Group 3 (up to the Infant Age of 6 Months)
30 days after the last vaccination at the age of 6 months of the infant series (i.e., at the age of 7 months)
Geometric Mean Concentration of Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA) Antibodies Before Vaccination With Hexacima® Vaccine Administered Along With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Day 0 (before the first vaccination with Hexacima® vaccine) of the infant series (i.e., at the age of 2 months)
Geometric Mean Concentrations of Anti-rotavirus Serum Immunoglobulin A (IgA) Antibodies Before and After RotaTeq® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Day 0 (before the first vaccination with RotaTeq® vaccine at the age of 2 months) and 30 days after the vaccination with RotaTeq® vaccine at the age of 6 months of the infant series (i.e., at the age of 7 months)
Geometric Mean Concentration of Anti-pneumococcal Antibodies After Prevnar 13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
30 days after the vaccination with Prevnar 13® vaccine at the age of 6 months of the infant series (i.e., at the age of 7 months)
- +39 more secondary outcomes
Study Arms (4)
Group 1: MenACYW Conjugate Vaccine (Mexico)
EXPERIMENTALParticipants aged 2 months (at the time of enrollment) received Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus toxoid (MenACYW) Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and measles, mumps, rubella (MMR®II) vaccine at the age of Month 12.
Group 2: Menveo® (Mexico)
ACTIVE COMPARATORParticipants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
Group 3: MenACYW Conjugate Vaccine (Russian Federation)
EXPERIMENTALParticipants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
Group 4: Routine Pediatric Vaccines (Russian Federation)
OTHERParticipants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
Interventions
Pharmaceutical form: Liquid solution Route of administration : Intramuscular
Pharmaceutical form: Lyophilized powder combined with liquid component Route of administration : Intramuscular
Pharmaceutical form: Lyophilized live virus vaccine Route of administration : Subcutaneous
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Pharmaceutical form: Powder and suspension for injection Route of administration: Intramuscular
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Pharmaceutical form: Oral solution Route of administration: Oral
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
Eligibility Criteria
You may qualify if:
- An individual must fulfill all of the following criteria in order to be eligible for trial enrollment:
- Infants 2 months of age (60 to 89 days of age) on the day of the first study visit.\*
- Born after a full-term pregnancy, with an estimated gestation age \>= 37 weeks and a birth weight \>= 2.5 kilograms.
- Informed consent form has been signed and dated by the parent(s) or guardian(s), as required by local regulations.†
- Participant and parent/guardian were able to attend all scheduled visits and to comply with all trial procedures.
- In good health as determined by medical history and physical assessment.
- For the Russian Federation: The participant's parents were able to verbally report or provide written documentation that the participant's mother was hepatitis B antigen negative during pregnancy with the participant.
- \* "2 months" means from the 2nd month after birth to the day before the 3rd month after birth (2 months to 2 months 29 days); "60 days" means from the 60th day after birth to the day before the 90th day after birth (60 to 89 days).
- † In the Russian Federation, as per local regulations, only the participant's parent(s) were entitled to sign an informed consent form. A child under the responsibility of a guardian would not be included in the study.
You may not qualify if:
- An individual fulfilling any of the following criteria was to be excluded from trial enrollment:
- Participation at the time of study enrollment or in the 4 weeks preceding the first trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
- Receipt of any vaccine in the 4 weeks preceding the first trial vaccination or planned receipt of any vaccine in the 4 weeks before and/or following any trial vaccination except for influenza vaccination, which may be received at a gap of at least 2 weeks before or 2 weeks after any study vaccination. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.
- Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (i.e., meningitis polysaccharide or meningitis Conjugate vaccine containing serogroups A, C, Y, or W; or meningococcal B serogroup-containing vaccine).
- Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type b (Hib), poliovirus, rotavirus, Streptococcus pneumoniae, measles, mumps, rubella, and / or varicella.
- For Mexico: More than 1 previous dose of hepatitis B vaccine.
- Receipt of immune globulins, blood or blood-derived products since birth.
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks) since birth.
- Family history of congenital or hereditary immunodeficiency until the immune competence of the potential vaccine recipient is demonstrated.
- Individuals with blood dyscrasias, leukemia, lymphoma of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems.
- Individuals with active tuberculosis.
- History of any Neisseria meningitidis infection, confirmed either clinically, serologically, or microbiologically.
- History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, hepatitis A, measles, mumps, rubella, Haemophilus influenzae type b, Streptococcus pneumoniae, and /or rotavirus infection / disease.
- At high risk for meningococcal infection during the trial (specifically, but not limited to, participants with persistent complement deficiency, with anatomic or functional asplenia, or participants traveling to countries with high endemic or epidemic disease).
- History of intussusception.
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Investigational Site Number :4840001
Acapulco de Juárez, Guerrero, 39670, Mexico
Investigational Site Number :4840002
Mexico City, Mexico City, 04530, Mexico
Investigational Site Number :4840003
Tlaltizapán, Morelos, 62770, Mexico
Investigational Site Number :6431018
Gatchina, Leningradskaya Oblast', 188300, Russia
Investigational Site Number :6431008
Krasnodar, 350015, Russia
Investigational Site Number :6431004
Perm, 614066, Russia
Investigational Site Number :6431007
Saint Petersburg, 191025, Russia
Investigational Site Number :6431010
Saint Petersburg, 196084, Russia
Investigational Site Number :6431001
Saint Petersburg, 197022, Russia
Investigational Site Number :6431006
Samara, 443079, Russia
Investigational Site Number :6431002
Yekaterinburg, 620028, Russia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Trial Transparency Team
- Organization
- Sanofi Pasteur
Study Officials
- STUDY DIRECTOR
Clinical Sciences & Operations
Sanofi
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2018
First Posted
August 15, 2018
Study Start
October 17, 2018
Primary Completion
February 18, 2022
Study Completion
February 18, 2022
Last Updated
October 19, 2023
Results First Posted
October 19, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will share
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