Safety of and immune response to Novartis MenACWY-CRM conjugate vaccine when given to healthy toddlers with and without ProQuad™ vaccine.

• Conditions: Prophylaxis for Neisseria meningitidis serogroup A, C,W-135,and Y.; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2014-004694-16-Outside-EU/EEA
• Lead Sponsor: ovartis Vaccines and 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: 1830

Inclusion Criteria

Individuals eligible for enrollment in this study were those:

Group I and II only:
? who were 7 to 9 months old (inclusive) and for whom, after the nature of the study
was explained, the parent or legal guardian provided written informed consent;

Group III only:
? who were 12 months old (inclusive, plus 14 days) and for whom, after the nature of
the study was explained, the parent or legal guardian provided written informed
consent;

All groups:
? who received complete primary vaccination with recommended licensed vaccines;
vaccination with Rotateq™ was not required for study entry
? who were available for all visits and telephone calls scheduled for the study;
? who were in good health as determined by:
- medical history
- physical assessment
- clinical judgment of the investigator
Are the trial subjects under 18? yes
Number of subjects for this age range: 1830
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 in the study were those:
? whose parent or legal guardian was unwilling or unable to give written informed
consent to participate in the study or who was unwilling or unable to give written
informed assent to participate in the study;
? whose parent or legal guardian was perceived to be unreliable or unavailable for the
duration of the study period;
? who had a previous or suspected disease caused by N. meningitidis;
? who had previous or suspected infection with measles, mumps, rubella, varicella,
and/or herpes zoster;
? who had household contact with and/or intimate exposure to an individual with
culture-proven N. meningitidis infection within 60 days prior to enrollment;
? who had household contact with and/or intimate exposure to an individual with
measles, mumps, rubella and/or varicella infection within 60 days prior to enrollment.

Study & Design

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