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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-003692-39-IT
Enrollment
Unknown
Registered
2007-07-12
Start date
2006-03-08
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

Healthy children MedDRA version: 6.1 Level: PT Classification code 10062163

Interventions

Trade Name: INFANRIX HEXA Pharmaceutical Form: Powder and solvent for solution for injection Trade Name: PREVENAR Pharmaceutical Form: Suspension for injection INN or Proposed INN: Pneumococcus, puri

Sponsors

AZIENDA OSPEDALIERA UNIVERSITARIA SAN MARTINO GENOVA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Main Objective: Assessment of immunogenicity of hexavalent vaccine singly administered or co-administered with 7-valent pneumococcal conjugate vaccine, measured as seropositive rate and GMC/GMT of specific antibodies against each antigen included in hexavalent vaccine.;Primary end point(s): Assessment of immunogenicity of hexavalent vaccine singly administered or co-administered with 7-valent pneumococcal conjugate vaccine, measured as seropositive rate and GMC/GMT of specific antibodies against each antigen included in hexavalent vaccine.;Secondary Objective: Evaluation of immunogenicity of 7-valent Pneumococcal Conjugate Vaccine, measured as seropositive rate e GMC/GMT of the specific antibodies against the seven pneumococcal vaccine serotypes. To evaluate the noninferior immune response induced by Infanrix Hexa given with 7vPnC, measured as seropositive rate and GMC/GMT of the specific antibodies against each antigen, in comparison with that one obtained when singly administered. Comparison of observed seropositive rates and of GMC/GMT versus literature's data—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026