Effect of 2 versus 3 pneumococcal conjugate vaccinations Prevnar on nasopharyngeal carriage, transmission and herd immunity; a randomized, controlled study.

Not Applicable

Completed

• Conditions: Invasive pneumococcal disease, Respiratory tract infection. Added as of 22/05/2007: Change in: nasopharyngeal carriage after reduced doses 7-valent conjugate vaccine, antipneumococcal antibody development, family transmission of pneumococci; Infections and Infestations; Invasive pneumococcal disease

• Registration Number: ISRCTN25571720
• Lead Sponsor: niversity Medical Centre Utrecht (UMCU) (Netherlands)

Brief Summary

1. 2009 results in: https://www.ncbi.nlm.nih.gov/pubmed/19584345 (added 31/05/2019) 2. 2010 results in: https://www.ncbi.nlm.nih.gov/pubmed/20823436 (added 31/05/2019) 3. 2011 results in: https://www.ncbi.nlm.nih.gov/pubmed/21695210 (added 31/05/2019) 4. 2011 results in: https://www.ncbi.nlm.nih.gov/pubmed/21813135 (added 31/05/2019) 5. 2013 results in: https://www.ncbi.nlm.nih.gov/pubmed/24120678 (added 31/05/2019) 6. 2014 results in: https://www.ncbi.nlm.nih.gov/pubmed/24447437 (added 31/05/2019) 7. 2014 results in: https://www.ncbi.nlm.nih.gov/pubmed/24921688 (added 31/05/2019) 8. 2014 results in: https://www.ncbi.nlm.nih.gov/pubmed/25329446 (added 31/05/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-12-20
• Study Completion: 2008-03-01
• Last Update Posted: 26 June 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1003

Inclusion Criteria

1000 healthy newborns (and family members) who will receive childhood vaccinations according to the national vaccination program, starting at 2 months of age.

Exclusion Criteria

Exclusion from the national vaccination program because of the presence of a medical condition requiring treatment that can interfere with the results of vaccinations, known of suspected allergy to components of the vaccine, known or suspected immunodeficiency disease other than IgA or IgG-subclass deficiency, previous treatment with plasma or immunoglobulins, previous vaccinations other than hepatitis B vaccinations, coagulations disorders

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pneumococcal nasopharyngeal carriage before 2 months of age, and at 6, 12, 18 and 24 months of age in vaccinated children (groups I and II) and controls (group III), and NP pneumococcal carriage of siblings and parents/caregivers when the baby is 12 and 24 months of age (herd immunity).