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

Completed

• Conditions: Prevention of invasive pneumococcal disease in healthy infants

• Registration Number: NL-OMON26724
• Lead Sponsor: Prof Dr EAM SandersUniversity Medical Center UtrechtDepartment of Pediatric ImmunologyHP 06.063.0Lundlaan 6POBox 850903508 AB Utrecht, The NetherlandsPhone 31 30 2504000Fax 31 30 2505350email l.sanders@umcutrecht.nl

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 1000

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).

Secondary Outcome Measures

Name	Time	Method
1. Determination of pneumococcal (vaccine and non-vaccine serotypes) colonization of infants in the Netherlands before introduction of Prevnar in the National Vaccination Program (group III);<br /><br>2. Evaluation of replacing pneumococcal serotypes after Prevnar vaccinations;<br /><br>3. Influence of Prevnar vaccinations on other colonizing bacterial species like Staphylococcus, H. influenzae, M. catarrhalis and Streptococcus>;<br /><br>4. Anti pneumococcal antibody levels at 12 and 24 months after 2 doses as compared to 2+1 Prevnar vaccinations;<br /><br>5. Relation between invasive pneumococcal disease and pneumococcal colonization in the Netherlands;<br /> <br>6. Evaluation of potential reduction of physician-diagnosed acute otitis media and lower respiratory tract infections after pneumococcal conjugate vaccinations.