A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Infants

• Conditions: Meningococcal disease causes high rates of morbidity and mortality even among patients who receive early antibiotic treatment.; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2014-004605-33-Outside-EU/EEA
• Lead Sponsor: ovartis Vaccines & Diagnostics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-17
• Last Update Posted: 24 November 2014

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 4500

Inclusion Criteria

Individuals eligible to be enrolled in the study were those:
1. who were healthy 2-month-old male or female infants (55 – 89 days, inclusive), who were born after full term pregnancy with an estimated gestational age = 37 weeks and a birth weight = 2.5 kg;
2. for whom a parent/legal representative had given written informed consent after the nature of the study had been explained;
3. who were available for all the visits scheduled in the study;
4. who were in good health as determined by:
a. medical history
b. physical assessment
c. clinical judgment of the investigator
Informed consent was obtained for all the subjects before enrollment into the study.
Are the trial subjects under 18? yes
Number of subjects for this age range: 4545
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

Individuals not eligible to be enrolled were those:
1. whose parent/legal representative was unwilling or unable to give written informed consent to participate in the study;
2. who had previously received any meningococcal vaccine;
3. who had received prior vaccination with D, T, P (acellular or whole cell), IPV or OPV, H. influenzae type b (Hib) or Pneumococcus (a single prior dose of BCG or HBV was not a reason for exclusion);
4. who had 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 longer than or equal to 2 weeks associated with apnea or whooping);
5. who had household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis (serogroups A, C, W135, or Y), B. pertussis, Hib, C. diphtheriae, Polio, or pneumococcal infection at any time since birth;
6. who had a history of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component;
7. who had experienced significant acute or chronic infection within the previous 7 days or have experienced fever (rectal temperature = 38.0°C [100.4°F]) within the previous 3 days;
8. who had any present or suspected serious acute (e.g. leukemia, lymphomas), or chronic disease (e.g., with signs of cardiac disease, renal failure, severe malnutrition, or insulin dependent diabetes), or progressive neurological disease, or a genetic anomaly/known cytogenetic disorders (e.g., Down’s syndrome);
9. who had a known or suspected autoimmune disease or persistent impairment/alteration of immune function resulting from (for example):
a. receipt of any immunosuppressive therapy at any time since birth
b. receipt of immunostimulants at any time since birth
c. receipt of any systemic corticosteroid since birth;
10. who had a suspected or known HIV infection or HIV related disease;
11. who had ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation;
12. who had a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;
13. who had any history of seizure (one febrile seizure is not a reason for exclusion);
14. who had received oral or parenteral antibiotic treatment in the 7 days prior to the scheduled blood draw;
15. who with their parents/legal representatives were planning to leave the area of the study site before the end of the study period;
16. with any condition which, in the opinion of the investigator, might have interfered with the evaluation of the study objectives;
17. who had taken any antipyretic medication in the previous 6 hours.
18. who had 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.

Study & Design

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