Healthy children Infections and Infestations Vaccination
Conditions
Interventions
Group A-D will be randomized using a random number table
1. Group A (n = 175) - will receive the vaccine at 2, 4, 6 and 12 months (The 'Classical' Group)
2. Group B (n = 175) - will receive the vaccin
Sponsors
Individual Sponsor (Israel)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age: Groups A, B, C, D: 2 m +/- 3 weeks Group E: 18 m +/- 1 m 2. Males or females 3. On time for routine immunization 4. For group E: Received previously 4 doses of Diphtheria, Tetanus, Pertussis (DTP), Haemophilus influenzae type b (Hib) and inactivated polio vaccine (IPV) 5. The parents and legal guardians must understand and be able, willing and likely to fully comply with the study procedures and restrictions 6. The parents and legal guardians must provide written informed consent 7. Patient must be healthy during vaccination procedure
Exclusion criteria
Exclusion criteria: 1. Prematurity of less than 35 weeks 2. Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without a fever. Study vaccines can be administered to persons with a minor illness such as diarrhea or mild upper respiratory infection (URI) without fever (rectal temperature 38.0 °C/100.4 °F prior to any injection 4. Any clinically important congenital abnormality, any inherited disorder of the metabolism 5. Thrombocytonpenia or any coagulation disorder that would contraindicate intramuscular (im) injection 6. Prior receipt of a licensed or investigational pneumococcal vaccine 7. Chronic (defined as more than 14 consecutive days) use of immunosuppressants or other immune-modifying drugs. For corticosteroids, this is defined as daily systemic therapy with prednisone or its equivalent at a dose of =2 mg/day. 8. Known or suspected allergy to any constituent of either product administered in the study 9. Known or suspected intolerance of hypersensitivity, to the study materials (or closely related compounds) or any of the stated ingredients, including diphtheria toxoid and tetanus toxoid 10. Hypotonic-hyporesponsive state within 48 hours after a prior dose of any vaccine 11. Persistent inconsolable crying lasting =3 hours within 48 hours after a prior dose of any vaccine 12. Known to be infected with human immunodeficiency virus (HIV) or mother is HIV positive 13. Any other condition or social circumstance (e.g. lack of a telephone, impending relocation) that, in the opinion of the investigator, would make the subject unsuitable or unable to complete the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pneumococcal carriage of Vaccine-type serotypes | — |
Secondary
| Measure | Time frame |
|---|---|
| Correlates between carriage and post vaccination antibodies | — |
Countries
Israel
Outcome results
None listed