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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date September 2018
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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.

Study Design


Intervention

Biological:
MenACWY-CRM
Subjects received the full dose (0.5 mL) of MenACWY-CRM, obtained by extemporaneous mixing of lyophilized MenA powder component and the MenCWY suspension, administered by IM injection into the anterolateral area of the right thigh.
MenC-CRM
One dose (0.5 mL) of MenC-CRM was obtained by extemporaneous mixing just before injection of the lyophilized MenC component and a saline solvent, administered by IM injection into the arm region.
DTaP-Hib-IPV

PC7
One dose (0.5 mL) of PC7, supplied in pre-filled syringe, administered by IM injection into the anterolateral area of the left thigh.
MMR

Varicella


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Novartis Vaccines

Country where clinical trial is conducted

Canada, 

Outcome

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
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