Meningococcal Meningitis Clinical Trial
Official title:
A Phase 2, Partially Randomized, Open Label, Multicenter Study to Evaluate the Safety and Immunogenicity After One or Two Doses of Novartis (Formerly Chiron) Meningococcal ACWY Conjugate Vaccine Administered to Healthy Infants and Young Children
NCT number | NCT00310856 |
Other study ID # | V59P9 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | June 2005 |
Est. completion date | November 2006 |
Verified date | September 2018 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To assess the immunogenicity of Novartis (formerly Chiron) Meningococcal ACWY conjugate vaccine (MenACWY) when administered as a two-dose schedule at 6 and 12 months of age.
Status | Completed |
Enrollment | 175 |
Est. completion date | November 2006 |
Est. primary completion date | November 2006 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Months to 12 Months |
Eligibility |
Inclusion Criteria: Inclusion criteria for Groups I (MenACWY-CRM_6-12 M) and II (MenACWY-CRM_12 M) Subjects eligible for enrollment in the study were healthy infants: 1. who were 6 months old and who were born after full-term pregnancy with an estimated gestational age of 37 weeks or greater and a birth weight 2.5 kg or greater; 2. who previously received two doses of PC7 and DTaP-Hib-IPV vaccines; 3. for whom a parent/legal guardian gave written informed consent, after the nature of the study was explained; 4. who were available for all the visits scheduled in the study; 5. who were in good health as determined by medical history, physical examination, and clinical judgment of the investigator. Inclusion criteria for Group III (MenC-CRM_12 M_MenACWY-CRM_18 M) Subjects eligible for enrollment in the study were healthy infants: 1. who were 12 months old; 2. who previously received three doses of DTaP-Hib-IPV (Pentacel) vaccines; 3. for whom a parent/legal guardian gave written informed consent, after the nature of the study was explained; 4. who were available for all the visits scheduled in the study; 5. who were in good health as determined by medical history, physical examination, and clinical judgment of the investigator. Exclusion criteria: Subjects were not to be included in this study if: 1. their parents/legal guardians were unwilling or unable to give written informed consent to participate in the study; 2. they previously received any meningococcal vaccine; 3. they had a previously ascertained or suspected disease caused by Neisseria meningitidis (N meningitidis); 4. they had a history of any anaphylactic shock, asthma, urticaria, or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component; 5. they had experienced significant acute or chronic infection within the previous 7 days or had experienced fever (38.0ºC or greater) within the previous 3 days; 6. they had any present or suspected serious acute disease (e.g., leukemia, lymphomas), or chronic disease (e.g., with signs of cardiac failure, renal failure, severe malnutrition, or insulin-dependent diabetes), or progressive neurological disease, or a genetic anomaly/known cytogenic disorders (e.g., Down's syndrome), or who had a diagnosed cardiac defect or abnormality of hemodynamic significance (e.g., ventricular septal defect, patent ductus arteriosus, or atrial septal defect); 7. they had a known or suspected autoimmune disease or impairment /alteration of immune function resulting from use of (for example): - any immunosuppressive therapy since birth; - immunostimulants since birth; - any systemic corticosteroid administered for more than 5 days or in a daily dose of greater than 1 mg/kg/day prednisone or equivalent for 5 days or less in the previous 30 days; 8. they had a suspected or known HIV infection or HIV-related disease; 9. they had received parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 90 days and were expected to receive it for the full length of the study; 10. they had a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time; 11. they had a history of seizure disorder: - febrile seizure; - any other seizure disorder; 12. they had taken systemic antibiotics (either oral or parenteral) within the previous 14 days (EXCEPTION: subjects who had received an oral or parenteral ß-lactam antibiotic [e.g.: penicillin, amoxicillin, ceftriaxone, cefuroxime or cephalexin] could have been enrolled 7 days following the last dose); 13. their parents/legal guardians were planning to leave the area of the study center before the end of the study period; 14. they had any condition which, in the opinion of the investigator, might have interfered with the evaluation of the study objectives. |
Country | Name | City | State |
---|---|---|---|
Canada | Clinical Trials Research Center, Department of Pediatrics, Dalhousie University, IWK Health Center | Halifax | |
Canada | Children's Hospital of Eastern Ontario Research Institute | Ottawa | Ontario |
Canada | Herridge Community Health Clinic | Ottawa | Ontario |
Lead Sponsor | Collaborator |
---|---|
Novartis Vaccines |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Subjects With hSBA Titers =1:4 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Immunogenicity was measured as the percentage of subjects with hSBA titers =1:4 against meningococcal serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), before vaccination and 1 month after 2-dose schedule of MenACWY-CRM administered at 6 and 12 months of age (MenACWY-CRM_6-12 M group) or 1-dose schedule administered at 12 months (MenACWY-CRM_12 M group) | Before and 1 month after 2-dose or 1-dose schedule | |
Secondary | Geometric Mean hSBA Titers Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | The immune response was measured as the hSBA geometric mean titers (GMTs) against meningococcal serogroups A, C, W and Y, before vaccination and 1 month after 2-dose schedule of MenACWY-CRM administered at 6 and 12 months of age (MenACWY-CRM_6-12 M group) or 1-dose schedule administered at 12 months of age (MenACWY-CRM_12 M group) | Before and 1 month after 2-dose or 1-dose schedule | |
Secondary | Percentage of Subjects With hSBA Titers =1:8 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Immunogenicity was measured as the percentage of subjects with hSBA titers =1:8 against meningococcal serogroups A, C, W and Y, before vaccination and 1 month after 2-dose schedule of MenACWY-CRM administered at 6 and 12 months of age (MenACWY-CRM_6-12 M group) or 1-dose schedule administered at 12 months of age (MenACWY-CRM_12 M) | Before and 1 month after 2-dose or 1-dose schedule | |
Secondary | Percentage of Subjects With hSBA Titers =1:4 or =1:8 Against Meningococcal Serogroup C After One Vaccination of MenC-CRM Administered at 12 Months of Age | Immunogenicity was measured as the percentage of subjects who achieved hSBA titers =1:4 or =1:8 against meningococcal serogroup C, before and 1 month after one vaccination of MenC-CRM administered concomitantly with Prevnar at 12 months of age | Before and 1 month after MenC-CRM vaccination at 12 months | |
Secondary | Geometric Mean hSBA Titers Against Meningococcal Serogroup C After One Vaccination of MenC-CRM Administered at 12 Months of Age | The immune response was measured as the hSBA GMT against meningococcal serogroup C, before and 1 month after one vaccination of MenC-CRM administered concomitantly with Prevnar at 12 months of age | Before and 1 month after MenC-CRM vaccination at 12 months | |
Secondary | Percentage of Subjects With hSBA Titers =1:4 or =1:8 Against Meningococcal Serogroup A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age | Immunogenicity was measured as the percentage of subjects who achieved hSBA titers =1:4 or =1:8 against meningococcal serogroups A, W and Y, before and 1 month after one vaccination of MenACWY-CRM administered concomitantly with Pentacel at 18 months of age | Before and 1 month after MenACWY-CRM vaccination at 18 months | |
Secondary | hSBA GMTs Against Meningococcal Serogroups A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age | The immune response was measured as the hSBA GMTs against meningococcal serogroups A, W and Y, before and 1 month after one vaccination of MenACWY-CRM administered concomitantly with Pentacel at 18 months of age | Before and 1 month after MenACWY-CRM vaccination at 18 months | |
Secondary | Percentage of Subjects With hSBA Titers =1:4 or =1:8 Against Meningococcal Serogroup C After MenACWY-CRM Vaccination Administered at 18 Months of Age, Following One Vaccination of MenC-CRM at 12 Months of Age | Booster response was measured as the percentage of subjects who achieved hSBA titers =1:4 or =1:8 against meningococcal serogroup C, before and 1 month after MenACWY-CRM vaccination administered at 18 months of age, following one vaccination of MenC-CRM at 12 months of age | Before and 1 month after MenACWY-CRM vaccination at 18 months | |
Secondary | hSBA GMT Against Meningococcal Serogroup C After MenACWY-CRM Vaccination Administered at 18 Months of Age, Following One Vaccination of MenC-CRM at 12 Months of Age | Booster response was measured as the hSBA GMT against meningococcal serogroup C, before and 1 month after MenACWY-CRM vaccination administered at 18 months of age, following one vaccination of MenC-CRM at 12 months of age | Before and 1 month after MenACWY-CRM vaccination at 18 months | |
Secondary | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | The safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 through day 7 following any vaccination of MenACWY-CRM, MenC-CRM and concomitant vaccination | From day 1 through day 7 after any vaccination |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01424644 -
A Phase 4, Placebo-Controlled, Randomized Study to Evaluate the Immunogenicity and Safety of HPV and Tdap When Administered With MenACWY in Adolescents
|
Phase 4 | |
Completed |
NCT01434680 -
Evaluating the Comparative Safety and Immunogenicity of Three Lots of Novartis Meningococcal C Conjugate Vaccine in Healthy Toddlers
|
Phase 2 | |
Completed |
NCT00384397 -
A Study of 2 Doses of Menactra®, a Meningococcal Conjugate Vaccine in Healthy Toddlers
|
Phase 3 | |
Completed |
NCT01453348 -
Study to Evaluate the Safety and Immunogenicity of Combined Hepatitis A/B Vaccine With MenACWY-CRM Conjugate Vaccine
|
Phase 3 | |
Completed |
NCT01214837 -
Safety and Immunogenicity of 2 or 3 Doses of MenACWY Conjugate Vaccine in Healthy Infants and the Effects of a Booster Dose of MenACWY Administered in the Second Year of Life
|
Phase 3 | |
Completed |
NCT00874549 -
Exploratory Trial to Evaluate the Safety and Immunogenicity of Menactra® and Menomune® Vaccines in Subjects ≥ 56 Years
|
Phase 1/Phase 2 | |
Completed |
NCT00355121 -
Study of Menactra® in Children Aged 4 to 6 Years When Administered Concomitantly With a Fifth Dose of DAPTACEL®
|
Phase 2 | |
Completed |
NCT02591290 -
Immunogenicity and Safety of Two-Dose Series of Menactra® in Japanese Healthy Adult Subjects
|
Phase 4 | |
Completed |
NCT01717638 -
Persistence of Antibody Levels and Response to Fifth or Third Meningococcal B Recombinant Vaccine in 4-year Old Healthy Children Who Previously Participated in Study V72P12E1
|
Phase 3 | |
Completed |
NCT01466387 -
A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Select Travel Vaccines When Administered Concomitantly With MenACWY in Adults
|
Phase 3 | |
Completed |
NCT01482052 -
Safety Study of Group A, C, Y & W-135 Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine for Meningitis
|
Phase 1 | |
Completed |
NCT01239043 -
Antibody Persistence and Response to Re-vaccination With Either Menactra® or Menomune® 3 Years After Initial Vaccination
|
Phase 2 | |
Completed |
NCT00994695 -
Safety, Immunogenicity and Reactogenicity Trial of Mencevax ACW135 Vaccine
|
Phase 2 | |
Completed |
NCT01732627 -
Study of a Quadrivalent Meningococcal Conjugate Vaccine in Subjects Aged 56 and Older
|
Phase 2 | |
Completed |
NCT01478347 -
A Phase 3b Study to Assess the Safety of Novartis Meningococcal B Recombinant Vaccine When Administered in Healthy At-risk Adults
|
Phase 3 | |
Completed |
NCT00483574 -
Study of the Safety of Menactra® Vaccine When Administered With Other Pediatric Vaccines to Healthy Toddlers
|
Phase 3 | |
Completed |
NCT00474487 -
A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Healthy Adults
|
Phase 3 | |
Completed |
NCT03205358 -
Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Toddlers
|
Phase 2 | |
Not yet recruiting |
NCT06226714 -
A Clinical Trial of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector) in 18-59 Year Olds
|
Phase 3 | |
Completed |
NCT00667602 -
Safety and Immunogenicity Evaluation After One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants and Toddlers
|
Phase 3 |