Pneumococcal immune response to Synflorix® or Prevenar-13® in infants.

Completed

• Conditions: Infectious diseases, Streptococcus pneumonia, pneumococcal vaccination

• Registration Number: NL-OMON29635
• Lead Sponsor: ational Institute for Public Health and the Environment (RIVM), Centre for Infectious Disease Control (CIb)

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: 160

Inclusion Criteria

1. The children have to be of normal health (same health criteria apply as used in well-baby clinics when a child receives a vaccination, e.g. also children with small increases in temperature (<38.5C) or cold are seen as children with normal health);

2. The parents/legally representatives have to be willing and able to allow their child to participate in the trial according to the described procedures;

Exclusion Criteria

1. PCV13 group: Previous vaccinations with PCV7 or PCV10;

2. PCV10 group: Previous vaccinations with PCV7 or PCV13;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Cellular immune response (Plasma B cells and memory B cells) immediately before and 7-9 days after the booster at 11-months of age;<br /><br>2. Humoral immune response (antibody concentrations and geometric mean concentrations (GMT)) at 12 months of age.

Secondary Outcome Measures

Name	Time	Method
1. Opsonophagocytoses immediately before and 7-9 days after the booster at 11-months of age;<br /><br>2. Avidity at 5, 8, immediately before and 7-9 days after the booster at 11-months and at 12 months of age;<br /><br>3. Antibody concentrations and geometric mean concentrations (GMT) at 5, 8, immediately before and 7-9 days after the booster at 11-months and at 12 months of age;<br /><br>4. Kinetics of antibody concentrations and geometric mean concentrations (GMT) over time (at 5, 8, 11 and 12 months of age);<br /><br>5. DTaP-HIb antibody concentrations and geometric mean concentrations (GMT) at 5, 8, 11 and 12 months of age.