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

Novartis

Status and phase: Completed; Phase 2

Conditions: Meningococcal Meningitis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00310856

V59P9

Details and patient eligibility

About

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.

Enrollment: 175 patients

Sex: All

Ages: 6 to 12 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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175 participants in 3 patient groups

MenACWY-CRM_6-12 M

Experimental group

Description:

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)

Treatment:

Biological: MMR

Biological: MenACWY-CRM

Biological: DTaP-Hib-IPV

Biological: Varicella

Biological: PC7

MenACWY-CRM_12 M

Experimental group

Description:

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)

Treatment:

Biological: MMR

Biological: MenACWY-CRM

Biological: DTaP-Hib-IPV

Biological: Varicella

Biological: PC7

MenC-CRM_12 M_MenACWY-CRM_18 M

Experimental group

Description:

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)

Treatment:

Biological: MMR

Biological: MenACWY-CRM

Biological: MenC-CRM

Biological: DTaP-Hib-IPV

Biological: Varicella

Biological: PC7