Immunogenicity of alternate and reduced immunization schedules using the regular thirteen-valent polysaccharide conjugate vaccine against infection with Streptococcus pneumoniae - Pneumococcal vaccination: reduced and different schedule

• Conditions: Immunogenicity of alternate and reduced immunization schedules using the regular thirteen-valent polysaccharide conjugate vaccine against infection with Streptococcus pneumoniae

• Registration Number: EUCTR2009-014315-12-NL
• Lead Sponsor: CIB/RIVM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-17
• Last Update Posted: 18 March 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Infants in good general health, eligible to be vaccinated according to the Dutch national vaccination program. The 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 or cold are seen as children with normal health.
•The parents have to be willing and able to allow their child to participate in the trial according to the described procedures
•Presence of a signed informed consent in which the parent(s)/legally representative(s) have given written informed consent after receiving oral and written information (signature from one parent in case of an orphan, or single-parent family).

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Any of the following criteria will exclude a volunteer from participation, at start of the study:
•Children elegible for the Hepatitis B vaccination
•Previous Prevenar and DTaP-IPV-Hib vaccination
•Present evidence of serious disease(s) demanding immunosuppressive medical treatment, like cytostatics and prednisolons, that might interfere with the results of the study within 3 months
•Any known primary or secondary immunodeficiency
•Communication problems interfering in the study realization
•Use of blood or bloodproducts
•Bleeding disorders
•Premature birth (<37 weeks)

Delay criteria
•In case of fever (>38.5 oC) the vaccination will be postponed
•In case a child is having fever (>38.5 oC) within one day before blood sampling which can interfere with the cellular immune responses at that time, another appointment for blood sampling will be made

Elimination criteria
•Use of blood or bloodproducts
•Long-term use of immunosuppressent medication, like cytostatics and prednisolons

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified