Evaluation of alternative vaccination schedules for Pneumococcal Conjugate Vaccine (PCV) (Philippines)

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2004
INTERVENTION: The study is a multi‐centre, individual‐randomised, open, proof of principle phase II trial to be carried out in Cabuyao, the Philippines with 4 arms. The study groups will receive 1, 2 or 3 doses of 7‐valent pneumococcal conjugate vaccine (PCV), reference group will receive the standard 3‐dose schedule of PCV and the control group no pneumococcal vaccines except at the exit from study. The effect of boosting at 9 months of age with pneumococcal polysaccharide vaccine after one or two doses of PCV on the antibody concentrations and B cell memory will be studied as well as the possible induction of hyporesponsiveness. CONDITION: Pneumococcus/vaccines ; Infections and Infestations ; Vaccination PRIMARY OUTCOME: Not provided at time of registration SECONDARY OUTCOME: Not provided at time of registration INCLUSION CRITERIA: Children who: 1. Are considered to be in good health on the basis of medical history and physical examination 2. Born at full term of pregnancy (=37 weeks) 3. Are at least 6 weeks (max 9 weeks) of age when starting the Diphtheria, Tetanus, Pertussis (DTP) 4. Whose parents have lived in the study area at least 3 months and have no intention to move out of the area during the next 9 months 5. For whom at least one of the parents or other legally acceptable representative has given his/her informed consent attested by a signature
Epistemonikos ID: c3b838158b0df399f3a5c9ba64c65ad8467fabba
First added on: Aug 21, 2024