Impact of conjugate versus polysaccharide quadrivalent ACWY vaccine on meningococcal carriage among Hajj pilgrims

Phase 4

Completed

• Conditions: meningococcal carriage; Infection - Studies of infection and infectious agents

• Registration Number: ACTRN12616001230448
• Lead Sponsor: ational Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases (NCIRS), The Children's Hospital at Westmead

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-05
• Study Completion: 2018-08-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1146

Inclusion Criteria

i)Any pilgrim planning to attend Hajj pilgrimage from the selected countries (Australia, Qatar and Saudi Arabia).
ii)Aged 18 years or older.
iii)Be able to provide informed consent.

Exclusion Criteria

i)Persons who received a MenACWY-C vaccine anytime in the past or a MenACWY-PS in the last three years will be excluded
ii)Persons on long-term steroids or other immune suppressants or immunodeficiency conditions will be excluded.
iii)Persons with previous history of invasive meningococcal disease will be excluded.
iv)Individuals with a history of systemic antibiotic use during the previous 7 days will be temporarily excluded but could be included after a lapse of 7 days since the last day of antibiotic administration. Individuals who give a history of using antibiotics during Hajj (following recruitment) will be retained in trial. A delayed swab, a week after completing the antibiotic course, will be attempted, but if that is not practical, they will be excluded them from the ‘per-protocol’ analysis. Individuals who received a conjugate monovalent meningococcal vaccine (MenC or MenA) in the past can be included into the study, but will be excluded for MenC- or MenA-specific analyses, but will be included for analyses with respect to the other serogroups.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the prevalence of serogroup-specific meningococcal carriage among Hajj pilgrims receiving quadrivalent meningococcal conjugate vaccine to that in those receiving quadrivalent meningococcal polysaccharide vaccine within sixty days after completion of Hajj .<br><br>Pharyngeal swabs will be obtained from the participants for microbiological testing. The rates of pharyngeal carriage of meningococcci in both vaccine arms will be compared by Pearson's chi-squared test in order to determine if the prevalence of serogroup-specific meningococcal carriage in Hajj pilgrims receiving quadrivalent meningococcal conjugate vaccine is different from that in pilgrims receiving quadrivalent meningococcal polysaccharide vaccine within 60 days (or 2 months) after completion of Hajj journey.[Within sixty days after completion of Hajj journey.]