Pediatric pneumococcal pneumonia, sepsis, meningitis. Respiratory Pneumonia
Conditions
Interventions
Study Vaccine Group: An eleven-valent pneumococcal tetanus-diphtheria toxoid conjugated vaccine, diphtheria-tetanus-pertussis whole cell vaccine, Haemophilus influenzae type b vaccine, hepatitis B vac
Sponsors
ARIVAC Consortium (Finland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For the effectiveness study and the nested immunogenicity study: 1. Any child who comes for routine vaccination to a barangay health station in the 48 barangays in the six municipalities of Bohol, the Philippines (i.e. Baclayon, Balilihan, Cortes, Dauis, Panglao and Tagbilaran) 2. Considered to be in good health on the basis of medical history and observation taken at the barangay health station 3. At least 6 weeks of age and not older than 6 months of age 4. Having at least one parent or other legal representative giving their informed consent attested by signature For the effectiveness study: Is a resident of any of the barangays within the catchment of the 45 barangay health stations of the six municipalities for at least the past 3 months with his/her family, or intends to stay permanently For the nested immunogenicity, safety and carriage study: Is a resident of any of the barangays within the catchment of the three chosen barangay health stations (i.e. Dampas-Tagbilaran, Danao and Main Health Center-Panglao) for at least the past 3 months with his/her family, or intends to stay permanently
Exclusion criteria
Exclusion criteria: For the effectiveness study and the nested immunogenicity study: Any child who: 1. Has received the first dose of diphtheria, tetanus, pertussis (DTP) vaccine 2. Has acute febrile illness (rectal temperature >/= 38.5°C) at the time of inclusion 3. Is suspected to have a neurological disease (a contraindication to the DTP vaccine) 4. Has history of hospitalization for and/or treatment for immune suppression 5. Is enrolled or scheduled to be enrolled in another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiologically confirmed, community-acquired pneumonia at least 14 days after the third dose of the study vaccine in first 2 years of life. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes: World Health Organisation (WHO) Pneumonia 1.1. Any episode of community-acquired pneumonia requiring or not requiring hospitalization 1.2. Any episode of community-acquired pneumonia requiring hospitalization 2. Any episode of community-acquired pneumonia not requiring hospitalization 3. Any episode of culture proven invasive pneumococcal disease, determined as vaccine-specific serotype, vaccine-related serotype, vaccine serogroup, or non-vaccine serotype or group of Streptococcus pneumoniae 4. Safety of the 11PCV when administered concomitantly with the EPI and Hib vaccines 5. Reactogenicity of the 11PCV after each injection 6. Immunogenicity and the opsonophagocytic activity (OPA) of the 11PCV in 11PCV and placebo recipients 7. Nasopharyngeal carriage of vaccine and non-vaccine specific serotypes of Streptococcus pneumoniae in 11PCV and placebo recipients | — |
Countries
Philippines
Outcome results
None listed