NCT00678301 - 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)

Dicko A, Odusanya OO, Diallo AI, Santara G, Barry A, Dolo A, Diallo A, Kuyinu YA, Kehinde OA, François N, Borys D, Yarzabal JP, Moreira M, Schuerman L
Primary vaccination with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in infants in Mali and Nigeria: a randomized controlled trial. BMC Public Health. 2011 Nov 23;11:882. doi: 10.1186/1471-2458-11-882.
Odusanya OO, Kuyinu YA, Kehinde OA, Francois N, Yarzabal JP, Moreira M, Borys D, Schuerman L
Immunogenicity, safety and reactogenicity of the 10-valent pneumococcal non-typeable haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Nigerian Infants: a randomised trial. Niger Postgrad Med J. 2013 Dec;20(4):272-81.
Silfverdal SA, Coremans V, François N, Borys D, Cleerbout J
Safety profile of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Expert Rev Vaccines. 2017 Feb;16(2):109-121. doi: 10.1586/14760584.2016.1164044. Epub 2016 Sep 30. Review.

Primary Vaccination Course in Children Receiving the Pneumococcal Vaccine GSK 1024850A Co-administered With Zilbrix™ Hib and Polio Sabin™

Clinical trial NCT00678301 - References