Development of humoral and cellular immune response in infants after pneumococcal conjugate vaccinations with Synflorix® or Prevenar-13®

Development of humoral and cellular immune response in infants after pneumococcal conjugate vaccinations with Synflorix® or Prevenar-13® - Pneumococcal immune response to Synflorix® or Prevenar-13® in infants

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON37981

Enrollment

132

Registered

2011-08-01

Start date

2011-10-25

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pneumococcal infection Streptococcus pneumonia

Interventions

None listed

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: • 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 (

Exclusion criteria

Exclusion criteria: •Group 1: Previous vaccinations with Prevenar-7 or Synflorix •Group 2: Previous vaccinations with Prevenar-13 of Prevenar-7 •Vaccinations using a schedule that differs from the Dutch 3+1 schedule •Presence of a serious disease that requires medical care that can interfere with the results of the study •Known or expected allergy/hypersensitivity against one of the vaccine ingredients •Known or suspected immunological disorder •Previously administration of plasma products (including immunoglobulin), within three months of study enrolment •Presence of bleeding disorders •Communication problems that interfere with the trial •Prematurity (

Design outcomes

Primary

Measure	Time frame
Primary Pneumococcal serotypes • Cellular immune response (Plasma B cells and memory B cells) immediately before and 7-9 days after the booster at 11-months of age • Humoral immune response (antibody concentrations and geometric mean concentrations (GMT)) at 12 months of age	—

Secondary

Measure	Time frame
Secondary Pneumococcal serotypes • Opsonophagocytoses immediately before and 7-9 days after the booster at 11-months of age • Avidity at 5, 8, immediately before and 7-9 days after the booster at 11-months and at 12 months of age • 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 • Kinetics of antibody concentrations and geometric mean concentrations (GMT) over time (at 5, 8, 11 and 12 months of age) DTaP-HIb • Antibody concentrations and geometric mean concentrations (GMT) at 5, 8, 11 and 12 months of age	—

Measure

Time frame

Secondary Pneumococcal serotypes • Opsonophagocytoses immediately before and 7-9 days after the booster at 11-months of age • Avidity at 5, 8, immediately before and 7-9 days after the booster at 11-months and at 12 months of age • 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 • Kinetics of antibody concentrations and geometric mean concentrations (GMT) over time (at 5, 8, 11 and 12 months of age) DTaP-HIb • Antibody concentrations and geometric mean concentrations (GMT) at 5, 8, 11 and 12 months of age

—

Countries

Netherlands

Outcome results