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

NCT ID: NCT00310856

Last Updated: 2018-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 175 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2006-11-30

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.

Conditions

Meningococcal Meningitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

MenACWY-CRM_6-12 M

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)

Group Type: EXPERIMENTAL

MenACWY-CRM

Intervention Type: BIOLOGICAL

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.

DTaP-Hib-IPV

Intervention Type: BIOLOGICAL

PC7

Intervention Type: BIOLOGICAL

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

Intervention Type: BIOLOGICAL

Varicella

Intervention Type: BIOLOGICAL

MenACWY-CRM_12 M

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)

Group Type: EXPERIMENTAL

MenACWY-CRM

Intervention Type: BIOLOGICAL

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.

DTaP-Hib-IPV

Intervention Type: BIOLOGICAL

PC7

Intervention Type: BIOLOGICAL

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

Intervention Type: BIOLOGICAL

Varicella

Intervention Type: BIOLOGICAL

MenC-CRM_12 M_MenACWY-CRM_18 M

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)

Group Type: EXPERIMENTAL

MenACWY-CRM

Intervention Type: BIOLOGICAL

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

Intervention Type: BIOLOGICAL

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

Intervention Type: BIOLOGICAL

PC7

Intervention Type: BIOLOGICAL

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

Intervention Type: BIOLOGICAL

Varicella

Intervention Type: BIOLOGICAL

Interventions

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.

Intervention Type: BIOLOGICAL

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.

Intervention Type: BIOLOGICAL

DTaP-Hib-IPV

Intervention Type: BIOLOGICAL

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.

Intervention Type: BIOLOGICAL

MMR

Intervention Type: BIOLOGICAL

Varicella

Intervention Type: BIOLOGICAL

Other Intervention Names

Meningococcal ACWY conjugate vaccine; Meningococcal C conjugate vaccine; Combined vaccine containing diphtheria, tetanus, pertussis, Haemophilus influenzae type B and inactivated polio virus; Pentacel; Heptavalent conjugate pneumococcal; Prevnar; Measles, mumps and rubella

Eligibility Criteria

Inclusion Criteria

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.

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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novartis Vaccines

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott Halperin, Dr.

Role: PRINCIPAL_INVESTIGATOR

Novartis Vaccines & Diagnostics

Francisco Diaz-Mitoma, Dr.

Role: PRINCIPAL_INVESTIGATOR

Novartis Vaccines

Locations

Children's Hospital of Eastern Ontario Research Institute

Ottawa, Ontario, Canada

Herridge Community Health Clinic

Ottawa, Ontario, Canada

Clinical Trials Research Center, Department of Pediatrics, Dalhousie University, IWK Health Center

Halifax, , Canada

Countries

Canada

Other Identifiers

V59P9

Identifier Type: -

Identifier Source: org_study_id