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

Primary Purpose

Meningitis, Meningococcal Infection

Status

Completed

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate: Menactra®

Meningococcal Group C Conjugate vaccine: MenC

About this trial

This is an interventional prevention trial for Meningitis focused on measuring Meningitis, Meningococcal Infection, Menactra®, MenC

Eligibility Criteria

12 Months - 18 Months (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Menactra® Vaccine Group

Menjugate® Vaccine Group

Arm Description

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

Meningococcal vaccine naive participants will receive MenC vaccine (Menjugate) given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

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.

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.

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)

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

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

Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Any of the Study Vaccination

Solicited Injection site: Tenderness, Erythema and Swelling: Solicited Systemic: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability

Full Information

NCT ID

NCT01359449

First Posted

May 23, 2011

Last Updated

July 20, 2016

Sponsor

Sanofi Pasteur, a Sanofi Company

1. Study Identification

Unique Protocol Identification Number

NCT01359449

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Completed

Study Start Date

May 2011 (undefined)

Primary Completion Date

July 2012 (Actual)

Study Completion Date

November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi Pasteur, a Sanofi Company

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Meningitis, Meningococcal Infection

Keywords

Meningitis, Meningococcal Infection, Menactra®, MenC

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

123 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Menactra® Vaccine Group

Arm Type

Experimental

Arm Description

Arm Title

Menjugate® Vaccine Group

Arm Type

Active Comparator

Arm Description

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 Type

Biological

Intervention Name(s)

Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate: Menactra®

Other Intervention Name(s)

Menactra®

Intervention Description

0.5 mL, Intramuscular

Intervention Type

Biological

Intervention Name(s)

Meningococcal Group C Conjugate vaccine: MenC

Other Intervention Name(s)

Menjugate, MenC

Intervention Description

0.5 mL, Intramuscular

Primary Outcome Measure Information:

Title

Description

Time Frame

28 days post-vaccination

Title

Description

Time Frame

28 days post-vaccination

Secondary Outcome Measure Information:

Title

Description

Time Frame

28 days post-vaccination

Title

Description

Time Frame

28 days post-vaccination

Title

Description

Immunogenicity tests were performed at 18 and 19 months of age, respectively, before and after Pediacel® vaccination in the Menactra vaccine group

Time Frame

28 days post-vaccination

Title

Summary of Participants With Booster Response for Pediacel® Vaccine Antigens After Vaccination With Pediacel® Vaccine (Menactra Vaccine Group)

Description

Time Frame

28 days post-vaccination

Title

Description

Time Frame

Day 0 up to Day 7 post-vaccination

Title

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

Description

Time Frame

Day 0 up to Day 7 post-vaccination

Title

Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Any of the Study Vaccination

Description

Solicited Injection site: Tenderness, Erythema and Swelling: Solicited Systemic: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability

Time Frame

Day 0 up to Day 7 post-vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Months

Maximum Age & Unit of Time

18 Months

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Dierctor

Organizational Affiliation

Sanofi Pasteur SA

Official's Role

Study Director

Facility Information:

City

Pierrefonds

State/Province

Quebec

ZIP/Postal Code

H9H 4Y6

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

25285126

Citation

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. doi: 10.1155/2014/237560.

Results Reference

result

Links:

URL

http://www.sanofipasteur.com

Description

Related Info

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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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