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Meningococcal Polysaccharide Diphtheria Toxoid Conjugate: Menactra

Phase 3

Meningitis | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Aug 19, 2016

Success Probability

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment957

FDA Designations

No designations recorded

Clinical trial landscape

Meningococcal Polysaccharide Diphtheria Toxoid Conjugate: Menactra · 2 trials · 2 indications

Phase 3 1Phase 2 1
NCT01359449Study of Two Doses of Menactra® or One Dose of Monovalent Meningococcal Group C Vaccine With Routine ImmunizationsMeningitis
COMPLETED123 Analytics
PHASE3COMPLETED
Study of Two Doses of Menactra® or One Dose of Monovalent Meningococcal Group C Vaccine With Routine Immunizations
Meningitis
NCT01359449123
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Study Endpoints

Primary Endpoints

Geometric Mean Titers of Serum Bovine Albumin Baby Rabbit Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.
28 days post-vaccination

Immunogenicity tests were performed at 19 months of age in Menactra Vaccine Group after Menactra® vaccination and performed at 13 months and 19 months of age in the Menjugate Vaccine Group after Menjugate® vaccination

Number of Participants With Serum Bovine Albumin Baby Rabbit Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.
28 days post-vaccination

Immunogenicity tests were performed at 19 months of age in Menactra Vaccine Group after Menactra® vaccination and performed at 13 months and 19 months of age in the Menjugate Vaccine Group after Menjugate® vaccination

Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®
Day 28 post-vaccination

Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC)

Secondary Endpoints

Geometric Mean Titers of Serum Bovine Albumin Human Complement Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.
28 days post-vaccination
Number of Participants With Serum Bovine Albumin Human Complement Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.
28 days post-vaccination
Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age.
28 days post-vaccination
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Menactra® Vaccine GroupEXPERIMENTALMeningococcal vaccine naive participants will receive Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate vaccine (Menactra®) at 12 months of age and at 18 months of age concomitantly with routine vaccines administered as per provincial schedule
Menjugate® Vaccine GroupACTIVE_COMPARATORMeningococcal vaccine naive participants will receive MenC vaccine (Menjugate) given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
Meningococcal vaccine GroupEXPERIMENTALParticipants must have received Menactra vaccine 4 to 6 years prior to enrollment

Interventions

NameTypeDescription
Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate: Menactra®BIOLOGICAL0.5 mL, Intramuscular
Meningococcal Group C Conjugate vaccine: MenCBIOLOGICAL0.5 mL, Intramuscular
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Eligibility Criteria

Age Range12 Months to 18 Months
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Aged 12 months (365 to 400 days) on the day of inclusion * Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg * Informed consent form has been signed and dated by the parent(s) or other legally authorized representative * Subject and parent/legal repr...

Countries:CanadaUnited States
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