Safety and Immunogenicity of 2 or 3 Doses of MenACWY Conjugate Vaccine in Healthy Infants and the Effects of a Booster Dose of MenACWY Administered in the Second Year of Life

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

• Registration Number: EUCTR2014-004577-16-Outside-EU/EEA
• Lead Sponsor: ovartis Vaccines and Diagnostics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-07
• Last Update Posted: 10 November 2014

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 750

Inclusion Criteria

Infants of both genders in good general health were eligible for this
study. The parents/legal representatives had to provide written informed consent and be available for all study visits.
Are the trial subjects under 18? yes
Number of subjects for this age range: 750
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. Any individual who previously received any meningococcal vaccine or any vaccine against D, T, P, inactivated poliovirus vaccine (IPV) or oral polio vaccine (OPV), Hinfluenzae type b (Hib) or pneumococcus. Prior doses of BCG vaccine (1 dose) and/or HBV (up to 2) were permitted.
2. Any individual 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 of longer than or equal to 2 weeks associated with apnea or whooping).
3. Any individual who had household contact with and/or intimate exposure to an individual with laboratory confirmed N meningitidis (serogroups A, C, W, or Y), B pertussis, Hib, C diphtheriae, polio, or pneumococcal infection at any time since birth.
4. Any individual with a history of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component.
5. Any individual who had any present or suspected serious acute (eg, leukemia, lymphomas), or chronic disease (eg, with signs of cardiac disease, renal failure, severe malnutrition, or insulin dependent diabetes), or progressive neurological disease, or a genetic anomaly/known cytogenic disorders (eg, Down’s syndrome).
6. Any individual 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 any immunostimulants at any time since birth,
c. receipt of any systemic corticosteroids since birth.
7. Any individual who had suspected or known HIV infection or HIV related disease.
8. Any individual who had received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation (including Hepatitis B immune globulin).
9. Any individual who had a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
10. Any individual who had any history of seizure.
11. Any individual who with their parents/legal representatives were planning to leave the area of the study site before the end of the study period.
12. Any individual who had any condition which, in the opinion of the investigator, might have interfered with the evaluation of the study objectives.
13. Any individual who had received any investigational agents since birth or who expected to receive an investigational agent prior to the completion of the study (this includes all experimental preparations, including, for example, experimental feeding formulas).
14. Other vaccinations were not to be administered 28 days prior to visit 1 (age 2 months) through study termination except for vaccines that were specified in the study protocol. Influenza vaccines could be administered up to 15 days prior to study vaccines being administered and at least 15 days after study vaccinations had been administered.
15. Any individuals who were relatives of the research staff.

Study & Design

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