Immunogenicity and Safety of MenACWY in Infants (6 & 12 Months)

Phase 2

Completed

Conditions: Meningococcal Meningitis

Interventions: Biological: MenACWY-CRM
Biological: DTaP-Hib-IPV
Biological: MenC-CRM
Biological: PC7
Biological: MMR
Biological: Varicella

Registration Number: NCT00310856

Lead Sponsor: Novartis Vaccines

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 175

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:

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;
who previously received two doses of PC7 and DTaP-Hib-IPV vaccines;
for whom a parent/legal guardian gave written informed consent, after the nature of the study was explained;
who were available for all the visits scheduled in the study;
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:

who were 12 months old;
who previously received three doses of DTaP-Hib-IPV (Pentacel) vaccines;
for whom a parent/legal guardian gave written informed consent, after the nature of the study was explained;
who were available for all the visits scheduled in the study;
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:

their parents/legal guardians were unwilling or unable to give written informed consent to participate in the study;
they previously received any meningococcal vaccine;
they had a previously ascertained or suspected disease caused by Neisseria meningitidis (N meningitidis);
they had a history of any anaphylactic shock, asthma, urticaria, or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component;
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;
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);
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;
they had a suspected or known HIV infection or HIV-related disease;
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;
they had a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;
they had a history of seizure disorder:
- febrile seizure;
- any other seizure disorder;
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);
their parents/legal guardians were planning to leave the area of the study center before the end of the study period;
they had any condition which, in the opinion of the investigator, might have interfered with the evaluation of the study objectives.

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MenACWY-CRM_6-12 M	MenACWY-CRM	Subjects received 2 doses of MenACWY-CRM (1 dose at 6 and 12 months of age). Subjects also received routine vaccines: 2 doses of PC7 (1 dose at 6 and 12 months of age), 1 dose of DTaP-Hib-IPV (at 6 months of age) and 1 dose of MMR+Varicella (at 13 months of age)
MenACWY-CRM_6-12 M	PC7	Subjects received 2 doses of MenACWY-CRM (1 dose at 6 and 12 months of age). Subjects also received routine vaccines: 2 doses of PC7 (1 dose at 6 and 12 months of age), 1 dose of DTaP-Hib-IPV (at 6 months of age) and 1 dose of MMR+Varicella (at 13 months of age)
MenACWY-CRM_6-12 M	MMR	Subjects received 2 doses of MenACWY-CRM (1 dose at 6 and 12 months of age). Subjects also received routine vaccines: 2 doses of PC7 (1 dose at 6 and 12 months of age), 1 dose of DTaP-Hib-IPV (at 6 months of age) and 1 dose of MMR+Varicella (at 13 months of age)
MenACWY-CRM_6-12 M	Varicella	Subjects received 2 doses of MenACWY-CRM (1 dose at 6 and 12 months of age). Subjects also received routine vaccines: 2 doses of PC7 (1 dose at 6 and 12 months of age), 1 dose of DTaP-Hib-IPV (at 6 months of age) and 1 dose of MMR+Varicella (at 13 months of age)
MenACWY-CRM_12 M	DTaP-Hib-IPV	Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (1 dose at 6 and 12 months of age), 1 dose of DTaP-Hib-IPV (at 6 months of age) and 1 dose of MMR+Varicella (at 13 months of age)
MenACWY-CRM_12 M	PC7	Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (1 dose at 6 and 12 months of age), 1 dose of DTaP-Hib-IPV (at 6 months of age) and 1 dose of MMR+Varicella (at 13 months of age)
MenC-CRM_12 M_MenACWY-CRM_18 M	MenC-CRM	Subjects received 1 dose of MenC-CRM (at 12 months of age) and 1 dose of MenACWY-CRM (at 18 months of age). Subjects also received routine vaccines: 1 dose of PCV7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)
MenC-CRM_12 M_MenACWY-CRM_18 M	PC7	Subjects received 1 dose of MenC-CRM (at 12 months of age) and 1 dose of MenACWY-CRM (at 18 months of age). Subjects also received routine vaccines: 1 dose of PCV7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)
MenACWY-CRM_6-12 M	DTaP-Hib-IPV	Subjects received 2 doses of MenACWY-CRM (1 dose at 6 and 12 months of age). Subjects also received routine vaccines: 2 doses of PC7 (1 dose at 6 and 12 months of age), 1 dose of DTaP-Hib-IPV (at 6 months of age) and 1 dose of MMR+Varicella (at 13 months of age)
MenC-CRM_12 M_MenACWY-CRM_18 M	MenACWY-CRM	Subjects received 1 dose of MenC-CRM (at 12 months of age) and 1 dose of MenACWY-CRM (at 18 months of age). Subjects also received routine vaccines: 1 dose of PCV7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)
MenACWY-CRM_12 M	MenACWY-CRM	Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (1 dose at 6 and 12 months of age), 1 dose of DTaP-Hib-IPV (at 6 months of age) and 1 dose of MMR+Varicella (at 13 months of age)
MenACWY-CRM_12 M	Varicella	Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (1 dose at 6 and 12 months of age), 1 dose of DTaP-Hib-IPV (at 6 months of age) and 1 dose of MMR+Varicella (at 13 months of age)
MenC-CRM_12 M_MenACWY-CRM_18 M	MMR	Subjects received 1 dose of MenC-CRM (at 12 months of age) and 1 dose of MenACWY-CRM (at 18 months of age). Subjects also received routine vaccines: 1 dose of PCV7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)
MenACWY-CRM_12 M	MMR	Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (1 dose at 6 and 12 months of age), 1 dose of DTaP-Hib-IPV (at 6 months of age) and 1 dose of MMR+Varicella (at 13 months of age)
MenC-CRM_12 M_MenACWY-CRM_18 M	DTaP-Hib-IPV	Subjects received 1 dose of MenC-CRM (at 12 months of age) and 1 dose of MenACWY-CRM (at 18 months of age). Subjects also received routine vaccines: 1 dose of PCV7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)
MenC-CRM_12 M_MenACWY-CRM_18 M	Varicella	Subjects received 1 dose of MenC-CRM (at 12 months of age) and 1 dose of MenACWY-CRM (at 18 months of age). Subjects also received routine vaccines: 1 dose of PCV7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)

Primary Outcome Measures

Name	Time	Method
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	Before and 1 month after 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)

Secondary Outcome Measures

Name	Time	Method
Geometric Mean hSBA Titers Against Meningococcal Serogroup C After One Vaccination of MenC-CRM Administered at 12 Months of Age	Before and 1 month after MenC-CRM vaccination at 12 months	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
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	Before and 1 month after MenACWY-CRM vaccination at 18 months	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
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	Before and 1 month after 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)
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	Before and 1 month after MenC-CRM vaccination at 12 months	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
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination	From day 1 through day 7 after any 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
Geometric Mean hSBA Titers Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule	Before and 1 month after 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)
hSBA GMTs Against Meningococcal Serogroups A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age	Before and 1 month after MenACWY-CRM vaccination at 18 months	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
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	Before and 1 month after MenACWY-CRM vaccination at 18 months	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
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	Before and 1 month after MenACWY-CRM vaccination at 18 months	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

Trial Locations

Locations (3): Herridge Community Health Clinic
🇨🇦
Ottawa, Ontario, Canada
Children's Hospital of Eastern Ontario Research Institute
🇨🇦
Ottawa, Ontario, Canada
Clinical Trials Research Center, Department of Pediatrics, Dalhousie University, IWK Health Center
🇨🇦
Halifax, Canada