Immunologic non-inferiority and safety of the investigational pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) 4-dose vial presentation compared to the licensed PHiD-CV 1-dose vial presentation in infants: A phase III randomized study.

Journal: Vaccine
PMID:

Abstract

BACKGROUND: To support vaccination programs in developing countries, a 4-dose vial presentation of pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) was developed. This study assessed immunologic non-inferiority and safety of the investigational PHiD-CV 4-dose versus licensed 1-dose vial presentation in infants.

Authors

  • Khalequ Zaman
    International Centre for Diarrheal Disease Research, Bangladesh (icddr,b), 68 Shaheed Tajuddin Ahmed Sarani, Mohakhali, Dhaka 1212, Bangladesh. Electronic address: kzaman@icddrb.org.
  • Sheikh Farzana Zaman
    International Centre for Diarrheal Disease Research, Bangladesh (icddr,b), 68 Shaheed Tajuddin Ahmed Sarani, Mohakhali, Dhaka 1212, Bangladesh. Electronic address: sfzaman@icddrb.org.
  • Farzana Zaman
    International Centre for Diarrheal Disease Research, Bangladesh (icddr,b), 68 Shaheed Tajuddin Ahmed Sarani, Mohakhali, Dhaka 1212, Bangladesh. Electronic address: drlisa83@yahoo.co.in.
  • Asma Aziz
    International Centre for Diarrheal Disease Research, Bangladesh (icddr,b), 68 Shaheed Tajuddin Ahmed Sarani, Mohakhali, Dhaka 1212, Bangladesh. Electronic address: asma.aziz@icddrb.org.
  • Sayeed-Bin Faisal
    International Centre for Diarrheal Disease Research, Bangladesh (icddr,b), 68 Shaheed Tajuddin Ahmed Sarani, Mohakhali, Dhaka 1212, Bangladesh. Electronic address: sayeed.faisal@icddrb.org.
  • Magali Traskine
    GSK, 20 Avenue Fleming, B-1300 Wavre, Belgium. Electronic address: magali.x.traskine@gsk.com.
  • Md Ahsan Habib
    GSK, 20 Avenue Fleming, B-1300 Wavre, Belgium. Electronic address: Ahsan.M.Habib@gsk.com.
  • Javier Ruiz-Guiñazú
    GSK, 20 Avenue Fleming, B-1300 Wavre, Belgium. Electronic address: javier.x.ruiz@gsk.com.
  • Dorota Borys
    GSK, 20 Avenue Fleming, B-1300 Wavre, Belgium. Electronic address: Dorota.D.Borys@gsk.com.