Pneumococcus/vaccines Infections and Infestations Vaccination
Conditions
Interventions
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
Sponsors
Research Institute of Tropical Medicine (Philippines)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: Children who: 1. Have neurologic disease (an absolute contraindication to the DTP vaccine) 2. Have known or suspected impairment of immunological function 3. Have acute illness at the time of inclusion or have fever (rectal temperature =38°C) 4. Have already got their first DTP vaccine dose or first Hepatitis B Virus (HBV) dose, or first Haemophilus influenzae type b (Hib) dose 5. Have known or suspected history of severe atopy 6. Are enrolled or scheduled to be enrolled in another clinical trial 7. Have a history of documented invasive pneumococcal disease 8. Have received a corticosteroid therapy or immunoglobulin or blood products since birth 9. Will be unable to attend the schedule visits and to comply with the study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
Philippines
Outcome results
None listed