A Phase 3, Open-Label, Randomized, Multi-Center Study to Evaluate the Safety and Immunogenicity after One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine Administered to Healthy Infants and Toddlers

• Conditions: ovartis Meningococcal ACWY Conjugate Vaccine is intended for prevention of meningitidis and septicemia caused by Neisseria meningitidis serogroups A, C, W-135 and Y.

• Registration Number: EUCTR2007-004754-82-DE
• Lead Sponsor: ovartis Vaccines and Diagnostics S.r.l.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Individuals eligible to be enrolled in the study are those:
1.who are infants 6-month old inclusive, who were born after full term pregnancy with an estimated gestational age = 37 weeks and a birth weight = 2.5 kg;
2.who previously received three doses of both Prevenar (heptavalent conjugate pneumococcal) and Infanrix-hexa (DTaP-Hib-HBV-IPV) vaccines at least 30 days before study entry;
3.for whom a parent/legal representative has given written informed consent after the nature of the study has been explained;
4.who are available for all the visits scheduled in the study;
5.who 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:
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 are those:
- whose parent/legal representative is unwilling or unable to give written informed consent to participate in the study;
- who previously received any meningococcal vaccine;
- who have 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);
- who have a history of any anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component (including latex allergy);
- who have experienced significant acute or chronic infection within the previous 7 days or have experienced fever (temperature = 38.0°C) within the previous 3 days;

Study & Design

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