Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Toddlers

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02955797
• Date of registration: 03/11/2016
• Prospective Registration: Yes
• Primary sponsor: Sanofi Pasteur, a Sanofi Company
• Public title: Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Toddlers
• Scientific title: Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Toddlers 12 to 23 Months of Age.
• Date of first enrolment: February 24, 2017
• Target sample size: 918
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02955797
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Finland, Germany, Hungary, Spain

Contacts

• Name: Medical Director
• Affiliation: Sanofi Pasteur SA

Key inclusion & exclusion criteria

Inclusion Criteria:

- Aged 12 to 23 months on the day of the first study visit.

- Participants had received all recommended standard-of-care non-meningococcal
vaccinations according to his/her age as per local regulations.

- Informed consent form (ICF) had been signed and dated by the parent/legally acceptable
representative.

- Participant and parent/legally acceptable representative were able to attend all
scheduled visits and complied with all trial procedures.

- Covered by health insurance if required by local regulations.

- Participants had received any meningococcal vaccine in the second year of life (i.e.,
from 12 months of age).

- For Inclusion in Groups 1 and 2: Participants must not had received any vaccination
against meningococcal disease with either a trial vaccine or a licensed meningococcal
vaccine (i.e., polyvalent, polysaccharide, or Conjugate meningococcal vaccine
containing serogroups A, C, W, Y, B; or any monovalent or bivalent meningococcal
vaccine).

- For Inclusion in Groups 3 and 4: Participants must had previously received at least 1
dose of licensed monovalent meningococcal C Conjugate (MenC) vaccine during infancy
(i.e., before 12 months of age).

Exclusion Criteria:

- Participation in the 4 weeks preceding the 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 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 study investigational vaccines.
This exception included monovalent pandemic influenza vaccines and multivalent
influenza vaccines.

- Receipt of immune globulins, blood or blood-derived products in the past 3 months.

- For Groups 1 and 2 only: Vaccination against meningococcal disease with either a trial
vaccine or a licensed meningococcal vaccine (i.e., polyvalent, polysaccharide, or
Conjugate meningococcal vaccine containing serogroups A, C, W, Y, B; or any monovalent
or bivalent meningococcal vaccine).

- For Groups 3 and 4 only: Vaccination against meningococcal disease with either a trial
vaccine or a licensed meningococcal vaccine (i.e., polyvalent, polysaccharide, or
Conjugate meningococcal vaccine containing serogroups A, C, W, Y, B; or any monovalent
B meningococcal vaccine), except licensed monovalent meningococcal C Conjugate (MenC)
vaccination received during infancy.

- 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 (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).

- Known systemic hypersensitivity to any of the vaccine components, or history of a
life-threatening reaction to the vaccines used in the trial or to a vaccine containing
any of the same substances.

- Personal history of an Arthus-like reaction after vaccination with a tetanus
toxoid-containing vaccine.

- Personal history of Guillain-Barré Syndrome.

- Verbal report of thrombocytopenia, as reported by the parent/legally acceptable
representative contraindicating intramuscular vaccination in the Investigator's
opinion.

- Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion,
contraindicating intramuscular vaccination in the Investigator's opinion.

- Chronic illness that, in the opinion of the Investigator, is at a stage where it might
interfere with trial 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.



Age minimum: 12 Months
Age maximum: 23 Months
Gender: All

Health Condition(s) or Problem(s) studied

Meningitis

Meningococcal Infections

Meningococcal Meningitis

Intervention(s)

Biological: Meningococcal polysaccharide groups A, C, W-135 and Y Conjugate vaccine

Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine

Primary Outcome(s)

Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® in Meningococcal Vaccine Naïve Toddlers [Time Frame: Day 30 (post-vaccination)]

Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 1:8 Against Meningococcal Serogroups A, C, Y, and W in Toddlers Who Either Were Meningococcal Vaccine Naïve or Had Received Monovalent MenC Vaccination During Infancy [Time Frame: Day 30 (post-vaccination)]

Secondary Outcome(s)

Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® in Toddlers Who Had Received Monovalent MenC Vaccination During Infancy [Time Frame: Day 30 (post-vaccination)]

Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W in Toddlers Who Either Were Meningococcal Vaccine Naïve or Had Received Monovalent MenC Vaccination During Infancy [Time Frame: Day 30 (post-vaccination)]

Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® in Vaccine Naive Toddlers [Time Frame: Day 30 (post-vaccination)]

Secondary ID(s)

MET51

U1111-1161-2935

2016-000749-30

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 09/06/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02955797