NCT04078997 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Swarthout TD, Ibarz-Pavon A, Kawalazira G, Sinjani G, Chirombo J, Gori A, Chalusa P, Bonomali F, Nyirenda R, Bulla E, Brown C, Msefula J, Banda M, Kachala J, Mwansambo C, Henrion MY, Gordon SB, French N, Heyderman RS
A pragmatic health centre-based evaluation comparing the effectiveness of a PCV13 schedule change from 3+0 to 2+1 in a high pneumococcal carriage and disease burden setting in Malawi: a study protocol. BMJ Open. 2021 Jun 17;11(6):e050312. doi: 10.1136/bmjopen-2021-050312.

Pneumococcal Conjugate Vaccine 13 (PCV13) Schedule Change From 3+0 to 2+1 to Accelerate Reduction in Pneumococcal Vaccine Serotype Carriage in Blantyre, Malawi: an Effectiveness Study

Details for clinical trial NCT04078997

Clinical trial NCT04078997 - References