Study of Two Doses of Menactra® or One Dose of Monovalent Meningococcal Group C Vaccine With Routine Immunizations
This study has been completed.
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01359449
First received: May 23, 2011
Last updated: February 11, 2013
Last verified: February 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Meningitis Meningococcal Infection |
Biological: Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate: Menactra® Biological: Meningococcal Group C Conjugate vaccine: MenC |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| 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 |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Antibody titers against meningococcal serogroups (A, C, Y, and W 135) [ Time Frame: Pre and 28 Days post-vaccination ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]Solicited Injection site Tenderness, Erythema and Swelling: Solicited Systemic: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability,
| Enrollment: | 123 |
| Study Start Date: | May 2011 |
| Study Completion Date: | November 2012 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Meningococcal vaccine naive (Group 1)
Menactra vaccine given at 12 months of age and at 18 months of age concomitantly with routine vaccines administered as per provincial schedule
|
Biological: Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate: Menactra®
0.5 mL, Intramuscular
Other Name: Menactra®
|
|
Active Comparator: Meningococcal vaccine naive (Group 2)
MenC vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
|
Biological: Meningococcal Group C Conjugate vaccine: MenC
0.5 mL, Intramuscular
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 12 Months to 18 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT01359449 History of Changes |
| Other Study ID Numbers: | MTA73, U1111-1117-7073 |
| Study First Received: | May 23, 2011 |
| Last Updated: | February 11, 2013 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Sanofi:
|
Meningitis Meningococcal Infection Menactra® MenC |
Additional relevant MeSH terms:
|
Meningitis Meningococcal Infections Central Nervous System Infections Central Nervous System Diseases |
Nervous System Diseases Neisseriaceae Infections Gram-Negative Bacterial Infections Bacterial Infections |
ClinicalTrials.gov processed this record on May 22, 2013