Evaluation of immunogenicity of 7-valent Pneumococcal Conjugate Vaccine (Prevenar) and Hexavalent DtPa-HBV-IPV-Hib (InfaNrix Hexa), co-administered at the same time, versus Hexavalent vaccine, used in primary immunization schedule - ND

• Conditions: MedDRA version: 6.1Level: PTClassification code 10062163; Healthy children

• Registration Number: EUCTR2007-003692-39-IT
• Lead Sponsor: AZIENDA OSPEDALIERA UNIVERSITARIA SAN MARTINO GENOVA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

Inclusion Criteria

Healthy children >= 11 months of age, who received three doses of hexavalent vaccine (DtPa-HBV-IPV-Hib) or received three doses of hexavalent vaccine (DtPa-HBV-IPV-Hib) plus 7-valent Pneumococcal conjugate vaccine.
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 temporary condition which prevents the subject from drawing blood sample. Administration of immunosoppressants drugs or any confirmed or suspected immunosuppressive or immunodeficient condition. Administration of immunoglobulins and/or any blood products within the last three months. Participation in another investigational trial.

Study & Design

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