Healthy Volunteers Clinical Trial
Official title:
A Phase II, Randomized, Controlled, Double-Blind, Dosage and Adjuvant Justification, Safety and Immunogenicity Trial of Intramuscular Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine Adjuvanted With or Without Monophosphoryl Lipid A and Aluminum Hydroxide in Adults
The purpose of this study is to select the optimal formulation of the norovirus vaccine from different concentrations of virus-like particles (VLP), Aluminum Hydroxide and MPL adjuvant (3-O-desacyl-4'-monophosphoryl lipid A) for further development.
The vaccine being tested in this study is called norovirus GI.1/GII.4 bivalent virus-like
particle (VLP) vaccine adjuvanted with aluminum hydroxide and with or without monophosphoryl
lipid A (MPL). The norovirus vaccine is being tested to assess different formulations of the
vaccine that will then be further developed.
This study will look at the number of antibodies to norovirus formed in people who take
different formulations of the norovirus vaccine. The study will enroll approximately 420
patients. Participants will be randomly assigned (by chance) to one of fourteen treatment
groups—which will remain undisclosed to the patient and study doctor during the study (unless
there is an urgent medical need).
All participants will receive a vaccination on Day 1 and Day 28 of the study. Some treatment
arms will receive one dose of the norovirus vaccine and some arms will receive two. In order
to keep the treatment arms undisclosed to the patient and the doctor, those randomized to the
one dose groups will receive a dose of Hepatitis A vaccine on Day 1 followed by the norovirus
vaccine 28 days later. Participants will be asked to record any symptoms that may be related
to the vaccine or the injection site in a diary card for 7 days after each vaccination.
This multi-centre trial will be conducted in Belgium. The overall time to participate in this
study is up to 393 days. Participants will make 6 visits to the clinic, and will be contacted
by telephone twice for follow-up assessments.
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