Safety and Immunogenicity of Meningococcal ACWY Conjugate Versus Polysaccharide Vaccine in Children 2 to 10 Years of Age

• Conditions: ovartis Meningococcal ACWY Conjugate Vaccine is intended for prevention of meningitis and septicemia caused by Neisseria meningitidis A, C, W-135 and Y.; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2014-003514-91-Outside-EU/EEA
• Lead Sponsor: ovartis Vaccines and Diagnostics S.r.l.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-30
• Last Update Posted: 27 October 2014

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

1. 2-10 years of age inclusive whose parents or legal guardians have given written informed consent at the time of enrollment;
2. available for all visits and telephone calls (parents or legal guardians) scheduled for the study;
3. in good health as determined by:
• medical history,
• physical assessment,
• clinical judgment of the investigator;
4. up to date with primary course and booster vaccines [BCG, and 4 doses of diphtheria-tetanus-pertussis vaccine (DTP), oral polio vaccine (OPV) or inactivated polio vaccine (IPV), H. influenzae type b vaccine (Hib), measles-mumps-rubella vaccine (MMR) and hepatitis A or B,
according to the Argentinean vaccine calendar and subject age].
Are the trial subjects under 18? yes
Number of subjects for this age range: 1500
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. whose parent or legal guardian is unwilling or unable to give written informed consent to participate in the study;
2. whose parent or legal guardian is perceived to be unreliable or unavailable for the duration of the study period;
3. who had a previous or suspected disease caused by N. meningitidis;
4. who had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis infection within 60 days prior to enrollment;
5. who have previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s) (licensed or investigational);
6. who have received any investigational agents or vaccines within 90 days prior to enrollment or who expect to receive an investigational agent or vaccine prior to the completion of the study;
7. who have received any licensed vaccines within one month prior to enrollment or for whom receipt of a licensed vaccine is anticipated within one month after vaccination (Exception: Influenza vaccine may be administered up to 15 days prior to study vaccination and no less
than 15 days after study vaccination);
8. who have received a live viral vaccine within 60 days prior to enrollment;
9. who have experienced, within the 7 days prior to enrollment, significant acute or chronic infection (for example requiring systemic antibiotic treatment or antiviral therapy) or have experienced fever (defined as axillary temperature =38°C) within 3 days prior to
enrollment;
10. who have any serious acute, chronic or progressive disease (e.g., any history of neoplasm, cancer, diabetes, cardiac disease, autoimmune disease, Human Immunodeficiency Virus (HIV) infection or Acquired Immune Deficiency Syndrome (AIDS), or blood dyscrasias, with signs
of cardiac or renal failure or severe malnutrition). (Exception: Subjects with mild asthma are eligible for enrollment. Subjects with moderate or severe asthma requiring routine use of inhaled or systemic
corticosteroids are not eligible for enrollment);
11. who have epilepsy or any progressive neurological disease;
12. who have a history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine component;
13. who have a known or suspected impairment/alteration of immune
function, either congenital or acquired or resulting from (for example):
• receipt of immunosuppressive therapy within 30 days prior to enrollment (any systemic corticosteroid administered for more than 5 days, or in a daily dose >1 mg/kg/day prednisone or equivalent during any of 30 days prior to enrollment, or cancer chemotherapy),
• receipt of immunostimulants,
• receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 90 days prior to enrollment and for the full length of the study,
• Common childhood exanthematous diseases (varicella, mumps, measles, rubella) occurring 6 weeks prior to vaccination;
14. who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;
15. who have Down's syndrome or other known cytogenic disorders;
16. whose families are planning to leave the area of the study site before the end of the study period;
17. who have any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified