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Trial registered on ANZCTR
Registration number
ACTRN12616001230448
Ethics application status
Approved
Date submitted
30/08/2016
Date registered
5/09/2016
Date last updated
19/11/2019
Date data sharing statement initially provided
19/11/2019
Type of registration
Retrospectively registered
Titles & IDs
Public title
Impact of conjugate versus polysaccharide quadrivalent ACWY vaccine on meningococcal carriage among Hajj pilgrims
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Scientific title
Meningococcal disease at Hajj: Vaccine effects on short to medium-term meningococcal nasopharyngeal carriage: comparison of conjugate and polysaccharide quadrivalent ACWY vaccine
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Secondary ID [1]
290054
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Unknown
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
meningococcal carriage
300108
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Condition category
Condition code
Infection
299990
299990
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0
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Studies of infection and infectious agents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Meningococcal group A, C, W135 and Y conjugate vaccine.
A single 0.5 ml dose of the reconstituted vaccine (meningococcal A,C,W&Y conjugate vaccine) will be given intramuscularly and must be administered 1-2 months prior to departing for Hajj.
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Intervention code [1]
295777
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Prevention
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Comparator / control treatment
Meningococcal group A, C, W135 and Y polysaccharide vaccine.
A single 0.5 ml dose of the reconstituted vaccine (meningococcal A,C,W&Y polysaccharide vaccine) will be given subcutaneously and must be administered 1-2 months prior to departing for Hajj.
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Control group
Active
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Outcomes
Primary outcome [1]
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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 .
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.
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Assessment method [1]
299477
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Timepoint [1]
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Within sixty days after completion of Hajj journey.
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Secondary outcome [1]
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Study the changes in pharyngeal carriage rates of meningococci from prior to, until 2 months after vaccination,
Pharyngeal swabs will be obtained from the participants for microbiological testing. The rates of pharyngeal carriage of meningococcci before and after vaccination in each study arm will be compared by Pearson's chi-squared test,
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Assessment method [1]
327292
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Timepoint [1]
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Until 2 months after vaccination,
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Secondary outcome [2]
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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 6-11 months after immunisation.
Pharyngeal swabs will be obtained from the participants for microbiological testing. The rates of pharyngeal carriage of meningococcci in both study 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 6-11 months after vaccination.
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Assessment method [2]
327371
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Timepoint [2]
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6-11 months after the vaccination. The participants will be reached as soon as they are available 6 months after vaccination and can be swabbed till 11th month.
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Secondary outcome [3]
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Comparison of adverse events related to vaccination between study arms.
All study participants will be given a hand-held paper diary or those who prefer so, a web-based diary to complete online with their iPhones over a period of one week following vaccination. In addition, participants will be actively followed up with a telephone call to enquire about any adverse reactions (e.g. systemic side effects: fever, myalgia, lethargy/fatigue; local reactions: redness, pain, swelling, any other adverse events requiring medical attention) over the one week period following vaccination. All serious adverse events will be reported and managed according to the practice guidelines. Within 60 days after their return from Hajj, the participants will be enquired about their health including details of any illness particularly major ones requiring hospital admission. Additionally, their family physicians will be kept informed of their participation in the study and requested to report all visits and hospital admissions to the study team throughout the follow up period to identify any related adverse events, and breakthrough meningococcal disease.
The rates of adverse events in both vaccine arms will be compared by Pearson's chi-squared test in order to determine if the prevalence of adverse events in Hajj pilgrims receiving quadrivalent meningococcal conjugate vaccine is different from that in pilgrims receiving quadrivalent meningococcal polysaccharide vaccine.
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Assessment method [3]
327458
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Timepoint [3]
327458
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Within sixty days after coming from Hajj
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key 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.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Mean difference and 95% Confidence Interval (CI) between study groups will be calculated in the proportion of participants with documented pharyngeal carriage of groupable meningococci within sixty days after completion of Hajj (visit 2) for each serogroup contained within the vaccines.
Sample size per arm under a range of assumptions for prevalence of carriage in polysaccharide arm and a range of vaccine efficacy expectations (for the conjugate vaccine) is calculated. Conjugate meningococcal C vaccine is known to reduce carriage by at least 75% (Maiden et al. 2008); assuming 3% carriage (against any one serogroup) among Hajj pilgrims immunised with a polysaccharide vaccine, and a carriage rate of 0.75% in those receiving a conjugate vaccine a sample size of 567 per arm would be needed to achieve 80% power with 95% confidence level (2 sided alpha = 0.05) and 75% reduction in carriage in the conjugate vaccine arm compared to the polysaccharide vaccine arm.
Assuming that 20% of pilgrims will have received antibiotics at the Hajj and or a MenACWY-C in the past, and another 20% will be lost to follow-up, a total of 1780 pilgrims will be recruited for the study.
It is likely that pilgrims given the polysaccharide vaccine will not remain at the theoretical carriage rate of 3% but actually acquire carriage of meningococci during the Hajj, so that the measured colonisation rate in this arm may exceed 3% - as was demonstrated with pilgrims returning to Singapore after the 2001 Hajj and to Turkey after the 2010 Hajj (Ceyhan et al. 2013; Wilder-Smith et al. 2002). Hence this is a conservative power estimate and significant differences may well be shown with fewer participants.
In summary, over 2000 pilgrims will be screened from Muslim dominated areas of Australia, and major cities in Saudi Arabia to achieve a sample size of 1780 participants, of these 1400 will be recruited from Saudi Arabia, 200 from Australia and 180 from Qatar.
References:
Ceyhan M, Celik M, Demir ET, Gurbuz V, Aycan AE, Unal S. Acquisition of Meningococcal Serogroup W-135 Carriage in Turkish Hajj Pilgrims Who Had Received the Quadrivalent Meningococcal Polysaccharide Vaccine. Clin Vaccine Immunol. 2013;20(1):66-8.
Maiden MC, Ibarz-Pavon AB, Urwin R, Gray SJ, Andrews NJ, Clarke SC, et al. Impact of meningococcal serogroup C conjugate vaccines on carriage and herd immunity. J Infect Dis. 2008;197(5):737-43.
Wilder-Smith A, Barkham TM, Earnest A, Paton NI. Acquisition of W135 meningococcal carriage in Hajj pilgrims and transmission to household contacts: prospective study. BMJ. 2002;325(7360):365-6.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/01/2017
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Actual
23/04/2016
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Date of last participant enrolment
Anticipated
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Actual
24/08/2017
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Date of last data collection
Anticipated
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Actual
4/08/2018
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Sample size
Target
1780
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Accrual to date
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Final
1146
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Recruitment outside Australia
Country [1]
8152
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Saudi Arabia
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State/province [1]
8152
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Country [2]
8153
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Qatar
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State/province [2]
8153
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Funding & Sponsors
Funding source category [1]
294425
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Charities/Societies/Foundations
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Name [1]
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Qatar National Research Fund (QNRF)
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Address [1]
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Qatar National Research Fund, PO Box 5825, Doha
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Country [1]
294425
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Qatar
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Funding source category [2]
304309
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Charities/Societies/Foundations
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Name [2]
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Salem bin Mahfouz Foundation
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Address [2]
304309
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Red Sea Mall, King Abdulaziz Rd, Ash Shati, Jeddah 21146
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Country [2]
304309
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Saudi Arabia
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Primary sponsor type
Hospital
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Name
National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases (NCIRS), The Children's Hospital at Westmead
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Address
The Children's Hospital at Westmead, Cnr Hawkesbury Rd and Hainsworth St, Westmead, Locked Bag 4001, Westmead NSW 2145, Australia
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Country
Australia
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Secondary sponsor category [1]
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University
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Name [1]
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The University of Sydney
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Address [1]
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The University of Sydney, NSW 2006
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Country [1]
293277
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Human Research Ethics Committee, The University of Sydney
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Ethics committee address [1]
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Office of Research Integrity Research Portfolio Margaret Telfer Building (K07) 71-79 Arundel Street Forest Lodge NSW 2006
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Ethics committee country [1]
295851
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Australia
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Date submitted for ethics approval [1]
295851
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10/08/2015
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Approval date [1]
295851
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04/01/2016
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Ethics approval number [1]
295851
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2015/693
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Ethics committee name [2]
295853
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Sydney Children's Hospitals Network Human Research Ethics Committee
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Ethics committee address [2]
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Research Ethics Office Corner Hawkesbury Road and Hainsworth Street Locked Bag 4001 Westmead NSW 2145 Sydney Australia DX 8213 Parramatta
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Ethics committee country [2]
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Australia
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Date submitted for ethics approval [2]
295853
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27/05/2016
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Approval date [2]
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01/06/2016
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Ethics approval number [2]
295853
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HREC/16/SCHN/209
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Summary
Brief summary
Intense congestion, including shared accommodation and compromised hygiene, during mass events such as Hajj pilgrimage amplify the risk of invasive meningococcal disease. Intercontinental spread of serogroup A meningococcal disease in 1987 and serogroup W135 disease in 2000 and 2001 affected thousands of Hajj pilgrims globally. Quadrivalent meningococcal polysaccharide (serogroups A, C, W135 and Y) vaccine was able to bring these epidemics under control, but the vaccine is not effective at reducing pharyngeal carriage of meningococci. A conjugate vaccine can reduce long term meningococcal carriage; for example, the quadrivalent conjugate vaccine has been shown to reduce carriage over 12 months from vaccination in adults aged 18-24 years old. However, the impact of conjugate meningococcal vaccines on meningococcal carriage status among Hajj pilgrims, most of whom are older than 24 years, is not known. We, therefore, believe that a well-powered carriage study in Hajj pilgrims is an urgent need. During the Hajj 2017, we plan to conduct a single-blinded, randomised, controlled trial of quadrivalent meningococcal conjugate vaccine for head-to-head comparison with quadrivalent polysaccharide among pilgrims from Australia, Qatar and Saudi Arabia. Pilgrims from participating countries, planning to attend Hajj in Makkah in 2017 will be randomised to receive either a ‘conjugate vaccine’ or a ‘polysaccharide vaccine’. Following informed consent, pharyngeal swabs will be collected from pilgrims in both arms a few months before their travel to Hajj. The participants will then receive their respective vaccines (observers will remain blind to this selection), a second set of pharyngeal swabs will be collected within sixty days after completion Hajj, preferably within 7 days and a third set of pharyngeal swabs will be collected at 6 to 11 months. Pharyngeal swabs will be processed by standard culture methods to detect meningococcal carriage; isolates will be characterised by serogroup, subtype, serosubtype, and sequence type. The pharyngeal swabs will also be tested for any antimicrobial resistance elements present. Data will be anonymised and analysed for the following end points: a) comparison between the study arms with respect to pharyngeal carriage rates of meningococci after return from Hajj, b) change in pharyngeal carriage rates of meningococci from before to a few months after vaccination, and c) comparison of long term carriage rates at 6 to 11 months after vaccination between study arms, and d) comparison of adverse events related to vaccination between study arms. This research could inform renewed policy on meningococcal vaccination for Hajj pilgrims as well as for attendees of other large events.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Harunor Rashid
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Address
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National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases (NCIRS), The Children's Hospital at Westmead, Cnr Hawkesbury Rd and Hainsworth St, Westmead, Locked Bag 4001, Westmead NSW 2145
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Country
68694
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Australia
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Phone
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+61 29845 1489
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Fax
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+61 29845 1418
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Email
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[email protected]
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Contact person for public queries
Name
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Almamoon Mohammad Omar Badahdah
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Address
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National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases (NCIRS), The Children's Hospital at Westmead, Cnr Hawkesbury Rd and Hainsworth St, Westmead, Locked Bag 4001, Westmead NSW 2145
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Country
68695
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Australia
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Phone
68695
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+61 298451433
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Fax
68695
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+61 298451418
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Email
68695
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[email protected]
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Contact person for scientific queries
Name
68696
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Harunor Rashid
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Address
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National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases (NCIRS), The Children's Hospital at Westmead, Cnr Hawkesbury Rd and Hainsworth St, Westmead, Locked Bag 4001, Westmead NSW 2145
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Country
68696
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Australia
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Phone
68696
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+61 29845 1489
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Fax
68696
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+61 29845 1418
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Email
68696
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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