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Study of Two Doses of Menactra® or One Dose of Monovalent Meningococcal Group C Vaccine With Routine Immunizations

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ClinicalTrials.gov Identifier: NCT01359449
Recruitment Status : Completed
First Posted : May 24, 2011
Results First Posted : May 24, 2013
Last Update Posted : August 19, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE May 23, 2011
First Posted Date  ICMJE May 24, 2011
Results First Submitted Date  ICMJE April 4, 2013
Results First Posted Date  ICMJE May 24, 2013
Last Update Posted Date August 19, 2016
Study Start Date  ICMJE May 2011
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2013)
  • 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. [ Time Frame: 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. [ Time Frame: 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
Original Primary Outcome Measures  ICMJE
 (submitted: May 23, 2011)
  • Antibody titers against meningococcal serogroups (A, C, Y, and W 135) [ Time Frame: Pre and 28 Days post-vaccination ]
    Antibody titers measured by serum bactericidal assay (SBA) prior to the first Menactra® vaccination and 28 days after the second Menactra® vaccination.
  • Antibody titers at ≥1:8 against meningococcal serogroups (A, C, Y, and W 135) [ Time Frame: Pre and 28 Days post-vaccination ]
    Antibody titers measured by serum bactericidal assay using baby rabbit complement (SBA) prior to the first Menactra® vaccination and 28 days after the second Menactra® vaccination
Change History Complete list of historical versions of study NCT01359449 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2016)
  • 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. [ Time Frame: 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 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. [ Time Frame: 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
  • 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. [ Time Frame: 28 days post-vaccination ]
    Immunogenicity tests were performed at 18 and 19 months of age, respectively, before and after Pediacel® vaccination in the Menactra vaccine group
  • Summary of Participants With Booster Response for Pediacel® Vaccine Antigens After Vaccination With Pediacel® Vaccine (Menactra Vaccine Group) [ Time Frame: 28 days post-vaccination ]
    Pediacel vaccine administered only to the Menactra Vaccine Group. Booster response was defined as subjects with pre-dose titers < 4xLLOQ and have a 4-fold rise rate; or subjects with pre-dose titers ≥ 4xLLOQ and have a 2-fold rise rate
  • Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction 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 [ Time Frame: Day 0 up to Day 7 post-vaccination ]
    Solicited Injection site: Tenderness, Erythema and Swelling: Solicited Systemic: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 reactions defined as: Tenderness - Cries when injected limb is moved, or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 50 mm; Fever - > 39.5°C; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal - > 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Appetite lost - Refuses ≥ 3 feeds/meals or refuses most feeds/meals, and Irritability - Inconsolable.
  • Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age [ Time Frame: Day 0 up to Day 7 post-vaccination ]
    Solicited Injection site: Tenderness, Erythema and Swelling: Solicited Systemic: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 reactions defined as: Tenderness - Cries when injected limb is moved, or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 50 mm; Fever - > 39.5°C; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal - > 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Appetite lost - Refuses ≥ 3 feeds/meals or refuses most feeds/meals, and Irritability - Inconsolable.
  • Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Any of the Study Vaccination [ Time Frame: Day 0 up to Day 7 post-vaccination ]
    Solicited Injection site: Tenderness, Erythema and Swelling: Solicited Systemic: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability
Original Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2011)
Occurrence and intensity of solicited injection site and systemic reactions and unsolicited adverse event s occurring after each Menactra® or MenC vaccination [ Time Frame: Day 0 up to 6 months post-vaccination ]
Solicited Injection site Tenderness, Erythema and Swelling: Solicited Systemic: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability,
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Two Doses of Menactra® or One Dose of Monovalent Meningococcal Group C Vaccine With Routine Immunizations
Official Title  ICMJE Safety and Immunogenicity of Two Doses of Menactra® (Meningococcal [Groups A, C, Y, and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) or One Dose of Monovalent Meningococcal Group C Conjugate Vaccine Administered Concomitantly With Routine Immunizations Between 12 and 18 Months of Age in Canada
Brief Summary

The purpose for this study is to demonstrate the safety and immunogenicity of two doses of Menactra® administered between 12 and 18 months of age and concomitantly with routine immunization with two different provincial schedule

Primary Objectives:

  • To describe the immunogenicity of Menactra® administered concomitantly with routine immunizations at 12 and 18 months in naïve or Menjugate-primed (MenC-primed) infants (measured by serum bactericidal assay using baby rabbit complement [SBA-BR])
  • To describe the immunogenicity of MenC administered concomitantly with routine immunizations at 12 months of age (measured by SBA-BR)

Secondary Objectives:

Safety

  • To describe the safety profile of Menactra® and MenC vaccines after each dose when given concomitantly with routine immunization.

Immunogenicity

  • To describe the immunogenicity of both vaccines using serum bactericidal assay using human complement [SBA-HC]
  • To describe the immunogenicity of Pediacel administered at 18 months.
Detailed Description Participants depending on their groups will receive either two doses of Menactra vaccine concomitantly with the routinely recommended vaccines or one dose of MenC vaccine concomitantly with the routinely recommended vaccines and will be monitored for safety and immunogenicity. The duration of each subject's participation in the trial will be approximately 7 months.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Meningitis
  • Meningococcal Infection
Intervention  ICMJE
  • Biological: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate: Menactra®
    0.5 mL, Intramuscular
    Other Name: Menactra®
  • Biological: Meningococcal Group C Conjugate vaccine: MenC
    0.5 mL, Intramuscular
    Other Names:
    • Menjugate
    • MenC
Study Arms  ICMJE
  • Experimental: Menactra® Vaccine Group
    Meningococcal 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
    Intervention: Biological: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate: Menactra®
  • Active Comparator: Menjugate® Vaccine Group
    Meningococcal vaccine naive participants will receive MenC vaccine (Menjugate) given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
    Intervention: Biological: Meningococcal Group C Conjugate vaccine: MenC
Publications * Noya F, McCormack D, Reynolds DL, Neame D, Oster P. Safety and immunogenicity of two doses of quadrivalent meningococcal conjugate vaccine or one dose of meningococcal group C conjugate vaccine, both administered concomitantly with routine immunization to 12- to 18-month-old children. Can J Infect Dis Med Microbiol. 2014 Jul;25(4):211-6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 15, 2011)
123
Original Estimated Enrollment  ICMJE
 (submitted: May 23, 2011)
180
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 representative are able to attend all scheduled visits and to comply with all trial procedures
  • Group 1: Subject has received 3 primary vaccination doses of Pediacel as per routine immunization schedule
  • Group 3: Subject has received two doses of MenC vaccine at approximately 2 and 4 months of age as per Alberta immunization schedule.

Exclusion Criteria:

  • Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination
  • Planned participation in another clinical trial during the present trial period
  • Receipt of any vaccine in the 4 weeks preceding the first trial vaccination, except for influenza vaccination(s), which may be received at least two weeks before study vaccines
  • Planned receipt of any vaccine in the 4 weeks following any trial vaccination
  • Previous vaccination against Meningococcal disease OR
  • Subject has previously received only one dose of MenC vaccine, or more than two doses of MenC vaccine, or two doses of MenC vaccine with the most recent dose received in the past 6 months
  • Receipt of blood or blood-derived products in the past 3 months which might interfere with assessment of the immune response
  • 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)
  • Personal or maternal seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C, as reported by the parent/legal representative
  • History of documented invasive meningococcal disease
  • At high risk for meningococcal disease during the trial
  • 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
  • History of contraindication to receipt of pertussis-containing vaccine
  • Thrombocytopenia, as reported by the parent/legal representative, contraindicating intramuscular vaccination
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
  • History of seizures
  • Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
  • History of Guillain-Barré Syndrome.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Months to 18 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01359449
Other Study ID Numbers  ICMJE MTA73
U1111-1117-7073 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi ( Sanofi Pasteur, a Sanofi Company )
Study Sponsor  ICMJE Sanofi Pasteur, a Sanofi Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Dierctor Sanofi Pasteur SA
PRS Account Sanofi
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP