NCT03089086: B Part of It

South Australian Meningococcal B Vaccine Herd Immunity Study

Completed Phase 4 Last updated 2 July 2019

What this trial tests

Phase 4 trial testing Licensed 4CMenB vaccine in Meningococcal Disease in 34,489 participants. Completed in 31 December 2018.

Timeline

1 April 2017

Primary endpoint
13 July 2018

31 December 2018

Quick facts

Lead sponsor	University of Adelaide
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	34,489
Start date	1 April 2017
Primary completion	13 July 2018
Estimated completion	31 December 2018
Sites	1 location across Australia

Drugs / interventions tested

• Licensed 4CMenB vaccine — full drug profile →

Conditions studied

• Meningococcal Disease — all drugs for Meningococcal Disease →

Sponsor

University of Adelaide

Who can join

14 and older, any sex, with Meningococcal Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To estimate the effect on carriage, all year 10, 11, and 12 students will be offered 4CMenB vaccination in South Australia through schools over the study period with 50% of the students enrolled receiving the vaccine in 2017 and 50% in 2018. In year 10 and 11 students, posterior pharyngeal swabs will be obtained at baseline and 12 months post baseline to estimate the difference in carriage prevalence of all genogroups of N. meningitidis between vaccinated and unvaccinated participants.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Meningococcal B Vaccine and Meningococcal Carriage in Adolescents in Australia.
   Marshall HS, McMillan M, Koehler AP, Lawrence A, et al · · 2020 · cited 124× · PMID 31971677 · DOI 10.1056/nejmoa1900236
2. Impact of meningococcal vaccination on carriage and disease transmission: A review of the literature.
   Balmer P, Burman C, Serra L, York LJ. · · 2018 · cited 44× · PMID 29565712 · DOI 10.1080/21645515.2018.1454570
3. Serogroup-specific meningococcal carriage by age group: a systematic review and meta-analysis.
   Peterson ME, Li Y, Shanks H, Mile R, et al · · 2019 · cited 29× · PMID 31005910 · DOI 10.1136/bmjopen-2018-024343
4. B Part of It protocol: a cluster randomised controlled trial to assess the impact of 4CMenB vaccine on pharyngeal carriage of <i>Neisseria meningitidis</i> in adolescents.
   Marshall HS, McMillan M, Koehler A, Lawrence A, et al · · 2018 · cited 25× · PMID 29991629 · DOI 10.1136/bmjopen-2017-020988
5. Impact of Meningococcal B Vaccine on Invasive Meningococcal Disease in Adolescents.
   McMillan M, Wang B, Koehler AP, Sullivan TR, et al · · 2021 · cited 23× · PMID 33587122 · DOI 10.1093/cid/ciaa1636
6. Meningococcal Group B Vaccine For The Prevention Of Invasive Meningococcal Disease Caused By <i>Neisseria meningitidis</i> Serogroup B.
   Rivero-Calle I, Raguindin PF, Gómez-Rial J, Rodriguez-Tenreiro C, et al · · 2019 · cited 22× · PMID 31632103 · DOI 10.2147/idr.s159952
7. Persistence of the immune response after 4CMenB vaccination, and the response to an additional booster dose in infants, children, adolescents, and young adults.
   Martinón-Torres F, Nolan T, Toneatto D, Banzhoff A. · · 2019 · cited 18× · PMID 31246520 · DOI 10.1080/21645515.2019.1627159
8. Deciphering the role of nanoparticles for management of bacterial meningitis: an update on recent studies.
   Sharma N, Zahoor I, Sachdeva M, Subramaniyan V, et al · · 2021 · cited 17× · PMID 34545518 · DOI 10.1007/s11356-021-16570-y