NCT00466947 - 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)

Sáez-Llorens X, Rowley S, Wong D, Rodríguez M, Calvo A, Troitiño M, Salas A, Vega V, Castrejón MM, Lommel P, Pascal TG, Hausdorff WP, Borys D, Ruiz-Guiñazú J, Ortega-Barría E, Yarzabal JP, Schuerman L
Efficacy of 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine against acute otitis media and nasopharyngeal carriage in Panamanian children - A randomized controlled trial. Hum Vaccin Immunother. 2017 Jun 3;13(6):1-16. doi: 10.1080/21645515.2017.1287640. Epub 2017 Feb 25.
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.
Tregnaghi MW, Sáez-Llorens X, López P, Abate H, Smith E, Pósleman A, Calvo A, Wong D, Cortes-Barbosa C, Ceballos A, Tregnaghi M, Sierra A, Rodriguez M, Troitiño M, Carabajal C, Falaschi A, Leandro A, Castrejón MM, Lepetic A, Lommel P, Hausdorff WP, Borys D, Ruiz Guiñazú J, Ortega-Barría E, Yarzábal JP, Schuerman L; COMPAS Group
Efficacy of pneumococcal nontypable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in young Latin American children: A double-blind randomized controlled trial. PLoS Med. 2014 Jun 3;11(6):e1001657. doi: 10.1371/journal.pmed.1001657. eCollection 2014 Jun. Erratum in: PLoS Med. 2015 Jun;12(6):e1001850.

COMPAS: A Phase III Study to Demonstrate Efficacy of GSK Biologicals' 10-valent Pneumococcal Vaccine (GSK1024850A) Against Community Acquired Pneumonia and Acute Otitis Media

Details for clinical trial NCT00466947

Clinical trial NCT00466947 - References