safety and immunogenicity of 4 doses of MenACWY conjugate vaccine, administered concomitantly with routine vaccines, among infants aged 2 months

• Conditions: Prophylaxis against Neisseria meningitidis serogroups A, C, W, and Y; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2014-005061-72-Outside-EU/EEA
• Lead Sponsor: ovartis Vaccines and Diagnostics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-27
• Last Update Posted: 1 December 2014

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 520

Inclusion Criteria

1) Two month-old infants (aged 55 – 89 days). Babies must have been born after a full-term pregnancy with an estimated gestational age = 37 weeks and a birth weight = 2.5 kg.
2) Documented written informed consent has been provided by the parent/legal representative after the nature of the study has been explained.
3) Parent/legal representative are available for all visits scheduled in the study.
4) Subjects are in good health as determined by :
a) medical history
b) physical assessment
c) clinical judgment of the investigator
Are the trial subjects under 18? yes
Number of subjects for this age range: 520
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) Subjects who previously received any meningococcal vaccines or vaccines against diphtheria, tetanus, pertussis, polio (IPV or OPV), H. influenzae type b (Hib) or pneumococcus. Exceptions: prior doses HBV vaccination (one or two doses) are permitted.
2) Subjects who have a previous confirmed or suspected disease caused by N. meningitidis, C. diphtheriae, C. tetani, poliovirus, Hepatitis B, Hib, pneumococcus or B. pertussis (history of laboratory confirmed, or clinical condition of paroxysmal cough for a period of longer than or equal to 2 weeks associated with apnea or whooping).
3) Subjects who have had household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis, B. pertussis, Hib, C. diphtheriae, polio, or pneumococcal infection at any time since birth.
4) Subjects who have a history of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component.
5) Subjects who have any serious acute or chronic disease, neurological disease including seizures, congenital defects, or cytogenic disorders (e.g., Down syndrome).
6) Subjects who have a known or suspected autoimmune disease or persistent impairment/alteration of immune function.
7) Subjects who have a suspected or known HIV infection or were born to a mother known to be HIV positive.
8) Subjects who have ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation (including Hepatitis B immune globulin).
9) Subjects who have a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
10) Subjects who with their parents/legal representatives are planning to leave the area of the study site before the end of the study period.
11) Subjects who have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
12) Subjects who have received any investigational agents or vaccines since birth or who expect to receive an investigational agent or vaccine prior to the completion of the study.
13) Subjects who are relatives of site research staff working on this study.

Study & Design

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