Clinical trial NCT00310856: Immunogenicity and Safety of MenACWY in Infants (6 & 12 Months)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Meningococcal Meningitis
Keywords: meningitis
children
vaccine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-04-05
Enrollment: 175
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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 β-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.

Primary outcomes:
measure: 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
timeFrame: Before and 1 month after 2-dose or 1-dose schedule
Secondary outcomes:
measure: Geometric Mean hSBA Titers Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule
timeFrame: Before and 1 month after 2-dose or 1-dose schedule
measure: 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
timeFrame: Before and 1 month after 2-dose or 1-dose schedule
measure: 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
timeFrame: Before and 1 month after MenC-CRM vaccination at 12 months
measure: Geometric Mean hSBA Titers Against Meningococcal Serogroup C After One Vaccination of MenC-CRM Administered at 12 Months of Age
timeFrame: Before and 1 month after MenC-CRM vaccination at 12 months
measure: 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
timeFrame: Before and 1 month after MenACWY-CRM vaccination at 18 months
measure: hSBA GMTs Against Meningococcal Serogroups A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age
timeFrame: Before and 1 month after MenACWY-CRM vaccination at 18 months
measure: 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
timeFrame: Before and 1 month after MenACWY-CRM vaccination at 18 months
measure: 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
timeFrame: Before and 1 month after MenACWY-CRM vaccination at 18 months
measure: Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination
timeFrame: From day 1 through day 7 after any vaccination
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario Research Institute
state: Ontario
city: Ottawa
country: Canada
facility: Herridge Community Health Clinic
state: Ontario
city: Halifax
country: Canada
facility: Clinical Trials Research Center, Department of Pediatrics, Dalhousie University, IWK Health Center
Study officials:
affiliation: Novartis Vaccines & Diagnostics
name: Scott Halperin, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Novartis Vaccines
name: Francisco Diaz-Mitoma, Dr.
role: PRINCIPAL_INVESTIGATOR
References: