Immunogenicity and Safety of a Meningococcal Conjugate Vaccine Given Concomitantly With Other Vaccines in Toddlers
2 other identifiers
interventional
1,183
4 countries
37
Brief Summary
This Phase III, open-label, randomized, parallel-group, active-controlled, multicenter study was conducted to assess the immunogenicity and safety of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine when administered alone and in combination with other pediatric vaccines in healthy toddlers in South Korea, Thailand, the Russian Federation, and Mexico. Primary Objective:
- To describe the immunogenicity profile of MenACYW Conjugate vaccine administered alone or concomitantly with licensed pediatric vaccine(s) (measles-mumps-rubella vaccine \[MMR\] + Varicella, diphtheria, tetanus, acellular pertussis, hepatitis B, poliomyelitis, and Haemophilus influenzae type-b Conjugate vaccine \[DTaP-IPV-HB-Hib\], or pneumococcal Conjugate vaccine \[PCV13\]). Secondary Objective:
- To describe the immunogenicity profile of licensed pediatric vaccine(s) (MMR + Varicella, DTaP-IPV-HB-Hib, or PCV13) when administered alone or concomitantly with MenACYW Conjugate vaccine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2016
37 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
Study Start
First participant enrolled
November 7, 2016
CompletedFirst Submitted
Initial submission to the registry
June 28, 2017
CompletedFirst Posted
Study publicly available on registry
July 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 19, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 19, 2018
CompletedResults Posted
Study results publicly available
June 9, 2020
CompletedApril 5, 2022
March 1, 2022
1.7 years
June 28, 2017
May 20, 2020
March 24, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W Antibodies Following Injection With MenACYW Conjugate Vaccine Administered Alone or Concomitantly With Other Pediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by serum bactericidal assay using human complement (hSBA) assay. Data for this outcome measure was planned to reported for the combined population of Groups 1 and 10, Groups 2 and 11.
Day 0 and Day 30 post-vaccination
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Injection With MenACYW Conjugate Vaccine Administered Alone or With Other Pediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Data for this outcome measure was planned to be reported for the combined population of Groups 1 and 10, Groups 2 and 11.
Day 0 and Day 30 post-vaccination
Percentage of Participants With >=4-Fold Rise in Antibody Titers Against Meningococcal Serogroups A, C, Y, and W Following Injection With MenACYW Conjugate Vaccine Administered Alone or With Other Pediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Data for this outcome measure was planned to be reported for the combined population of Groups 1 and 10, Groups 2 and 11.
Day 0 up to Day 30 post-vaccination
Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y, and W Following Injection With MenACYW Conjugate Vaccine Administered Alone or Concomitantly With Pediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11
The hSBA vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers \>=1:16 for participants with pre-vaccination titers \<1:8 or at least a 4-fold increase in post-vaccination hSBA titers from pre- to post-vaccination, for participants with pre-vaccination titers \>=1:8. Data for this outcome measure was planned to be reported for the combined population of Groups 1 and 10, Groups 2 and 11.
Day 30 post-vaccination
Secondary Outcomes (12)
Geometric Mean Titers of MMR-Varicella Antibodies Following Injection With MMR-Varicella Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 1, 3, 10, and 12
Day 0 and Day 30 post-vaccination
Percentage of Participants With Immune Response Following Injection With MMR-Varicella Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 1, 3, 10, and 12
Day 0 and Day 30 post-vaccination
Geometric Mean Titers of Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA) Antibodies Following Injection With DTaP-IPV-HB-Hib Vaccine Administrated Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 4 and 6
Day 0 and Day 30 post-vaccination
Geometric Mean Titers of DTaP-IPV-HB-Hib Antibodies Following Injection With DTaP-IPV-HB-Hib Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 4 and 6
Day 0 (for tetanus only) and Day 30 post-vaccination
Percentage of Participants With Immune Response Following Injection With DTaP-IPV-HB-Hib Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 4 and 6
Day 0 (tetanus only) and Day 30 post-vaccination
- +7 more secondary outcomes
Study Arms (12)
South Korea(Group1):MenACYW Conjugate + MMR+ Varicella Vaccine
EXPERIMENTALHealthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine, MMR vaccine, and varicella vaccine on Day 0.
South Korea (Group 2): MenACYW Conjugate Vaccine
EXPERIMENTALHealthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
South Korea (Group 3): MMR + Varicella Vaccine
ACTIVE COMPARATORHealthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MMR vaccine and varicella vaccine on Day 0.
Thailand (Group 10):MenACYW Conjugate +MMR+Varicella Vaccine
EXPERIMENTALHealthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine, MMR vaccine, and varicella vaccine on Day 0.
Thailand (Group 11):MenACYW Conjugate Vaccine
EXPERIMENTALHealthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
Thailand (Group 12): MMR + Varicella Vaccine
ACTIVE COMPARATORHealthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MMR vaccine and varicella vaccine on Day 0.
Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine
EXPERIMENTALHealthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine and diphtheria, tetanus, acellular pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type-b (DTaP-IPV-HB-Hib) vaccine on Day 0.
Mexico (Group 5): MenACYW Conjugate Vaccine
EXPERIMENTALHealthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine
ACTIVE COMPARATORHealthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of DTaP-IPV-HB-Hib vaccine on Day 0.
Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine
EXPERIMENTALHealthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of MenACYW Conjugate vaccine and pneumococcal Conjugate vaccine (PCV13) on Day 0.
Russian Federation (Group 8): MenACYW Conjugate Vaccine
EXPERIMENTALHealthy, meningococcal-vaccine naïve toddlers (aged 12 to 14 months or 16 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
Russian Federation (Group 9): PCV13 Vaccine
ACTIVE COMPARATORHealthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of PCV13 vaccine on Day 0.
Interventions
Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine; 0.5 milliliter (mL), Intramuscular
Measles, Mumps, and Rubella Virus Vaccine Live; 0.5 mL, Subcutaneous
Varicella Virus Vaccine Live; 0.5 mL, Subcutaneous
Diphtheria, Tetanus, Pertussis (acellular component), Hepatitis B, Poliomyelitis (inactivated), and Haemophilus influenzae type-b conjugate vaccine (adsorbed); 0.5 mL, Intramuscular
Pneumococcal 13-valent Conjugate Vaccine; 0.5 mL, Intramuscular
Eligibility Criteria
You may qualify if:
- For South Korea: Korean males and females aged 12 to 23 months on the day of the first study visit.
- For Mexico: Males and females aged 12 to 23 months on the day of the first study visit.
- For the Russian Federation: Males and females aged 12 to 14 months or 16 to 23 months on the day of the first study visit (eligible for enrollment to MenACYW Conjugate vaccine group) or 15 to 23 months on the day of the first study visit (eligible for enrollment to the MenACYW Conjugate vaccine positive(+) PCV13 group or the PCV13 group).
- For Thailand: Thai males and females aged 12 to 23 months on the day of the first study visit
- Participants had received all recommended standard of care vaccinations according to their age as per local regulations\*.
- For the Russian Federation only, participants aged 15 to 23 months on the day of the first study visit (eligible for enrollment to MenACYW Conjugate vaccine+PCV13 group or the PCV13 group) must not had received the third PCV13 vaccination corresponding to his or her age as per the country's National Immunization Program (NIP). The 2nd dose of PCV13 must had been administered at least 4 weeks before the 3rd dose of PCV13 was administered in the study.
- For Thailand, participants must not have received the any dose of MMR or V vaccination.
- Informed consent form was signed and dated by the parent(s) or guardian if allowed by local regulations (and by independent witnesses if required by local regulations)†.
- Participant and parent/guardian were able to attend all scheduled visits and to comply with all trial procedures.
- †In the Russian Federation, as per local regulations, only the participant's parent(s) are entitled to sign an informed consent form. A child under the responsibility of a guardian were not included in the study.
You may not qualify if:
- Participation 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 (28 days) preceding the first trial vaccination or planned receipt of any vaccine prior to Visit 2 except for influenza vaccination, which may be received at least 2 weeks before or after the study investigational vaccines. 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., mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal B vaccine).
- For participants enrolled at sites in the Russian Federation: previous vaccination with the third dose of PCV13 in participants 15 to 23 months of age (eligible for MenACYW Conjugate vaccine+PCV13 group or the PCV13).
- For participants enrolled at sites in Mexico: known history of seizures, or uncontrolled neurologic disorder (including epilepsy); or encephalopathy of unknown etiology occurring within 7 days following previous vaccination with pertussis containing vaccine; previous vaccination with DTaP-IPV-HB-Hib or DTaP-containing vaccine at 12 to 23 months of age.
- For participants enrolled at sites in South Korea and Thailand: known history of seizures, cerebral injury, or encephalopathy; previous vaccination with MMR or Varicella at 12 to 23 months of age.
- 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).
- History of meningococcal infection, confirmed either clinically, serologically, or microbiologically.
- At high risk for meningococcal infection during the trial, according to the Investigator's judgment (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).
- Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances.
- Verbal report of thrombocytopenia, as reported by the parent/guardian, contraindicating intramuscular (IM) vaccination by the Investigator's judgment.
- Personal history of Guillain-Barré syndrome (GBS).
- Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine.
- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
Unknown Facility
Acapulco, 39670, Mexico
Unknown Facility
Mexico City, 04530, Mexico
Unknown Facility
Tlaltizapán, 62770, Mexico
Unknown Facility
Barnaul, 656054, Russia
Unknown Facility
Kazan', 420012, Russia
Unknown Facility
Krasnodar, 350015, Russia
Unknown Facility
Moscow, 119296, Russia
Unknown Facility
Murmansk, 183031, Russia
Unknown Facility
Novosibirsk, 630102, Russia
Unknown Facility
Perm, 614066, Russia
Unknown Facility
Saint Petersburg, 191025, Russia
Unknown Facility
Saint Petersburg, 197022, Russia
Unknown Facility
Saint Petersburg, 197101, Russia
Unknown Facility
Samara, 443079, Russia
Unknown Facility
Smolensk, 214014, Russia
Unknown Facility
Tomsk, 634050, Russia
Unknown Facility
Yekaterinburg, 620028, Russia
Unknown Facility
Ansan, 425-707, South Korea
Unknown Facility
Anyang, 431-070, South Korea
Unknown Facility
Daegu, 41931, South Korea
Unknown Facility
Daejeon, South Korea
Unknown Facility
Gwangju, 61469, South Korea
Unknown Facility
Ilsan, 10444, South Korea
Unknown Facility
Incheon, 400-700, South Korea
Unknown Facility
Jeju City, 63241, South Korea
Unknown Facility
Seoul, 02053, South Korea
Unknown Facility
Seoul, 05278, South Korea
Unknown Facility
Seoul, 100-380, South Korea
Unknown Facility
Seoul, 130-702, South Korea
Unknown Facility
Seoul, 132-703, South Korea
Unknown Facility
Seoul, 139-709, South Korea
Unknown Facility
Seoul, 158-710, South Korea
Unknown Facility
Suwon, 442-723, South Korea
Unknown Facility
Wŏnju, 162, South Korea
Unknown Facility
Yangsan, 626-770, South Korea
Unknown Facility
Pathum Wan, Bangkok, 10330, Thailand
Unknown Facility
Rajthevi, Bangkok, 10400, Thailand
Related Publications (1)
Dhingra MS, Namazova-Baranova L, Arredondo-Garcia JL, Kim KH, Limkittikul K, Jantarabenjakul W, Perminova O, Kobashi IAR, Bae CW, Ojeda J, Park J, Chansinghakul D, B'Chir S, Neveu D, Bonaparte M, Jordanov E. Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine administered concomitantly with other paediatric vaccines in toddlers: a phase III randomised study. Epidemiol Infect. 2021 Apr 5;149:e90. doi: 10.1017/S0950268821000698.
PMID: 33814028DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Trial Transparency Team
- Organization
- Sanofi Pasteur
Study Officials
- STUDY DIRECTOR
Medical Director
Sanofi Pasteur, a Sanofi Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The study had an open-label design; however, as per the protocol, the laboratory technicians who were responsible for performing the serological testing remained blinded to the participants' group allocations throughout the study to avoid any bias.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2017
First Posted
July 2, 2017
Study Start
November 7, 2016
Primary Completion
July 19, 2018
Study Completion
July 19, 2018
Last Updated
April 5, 2022
Results First Posted
June 9, 2020
Record last verified: 2022-03
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