A study comparing the effect of various schedules of the 7-valent licensed CRM197 - conjugated pneumococcal vaccine (Prevnar®) on carriage of Streptococcus pneumoniae in infants and toddlers

Completed

• Conditions: Healthy children; Infections and Infestations; Vaccination

• Registration Number: ISRCTN28445844
• Lead Sponsor: Individual Sponsor (Israel)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-01
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 730

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

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).
3. Axillary 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pneumococcal carriage of Vaccine-type serotypes

Secondary Outcome Measures

Name	Time	Method
Correlates between carriage and post vaccination antibodies