Phase III, multi-center trial in 795 infants in the Czech Republic, Germany, and Spain. Subjects from the Czech Republic and Germany will be randomized in Groups 1 and 2 to receive in a blind-observer manner, the investigational DTaP IPV HB Hib vaccine or the control vaccine, Infanrix™ hexa, concomitantly with the administration of Prevenar® 13 at 2, 3, and 4 months of age; the subjects from Spain (in Group 3) who had received a first dose of hepatitis B vaccine prior to the study will be allocated to receive in an open-label manner, the investigational DTaP IPV HB Hib vaccine at 2 and 6 months of age, and Pentavac™ vaccine at 4 months of age, concomitantly with Prevenar 13 at 2 and 4 months of age (or at 2, 4 and 6 months of age) and RotaTeq® at 2, 4 and 6 months of age.

Sanofi Pasteur SA0 sites795 target enrollmentOctober 14, 2013

ConditionsPrevention of infections caused by Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, poliovirus type 1, 2 and 3, prevention against invasive infections caused by Haemophilus influenzae type b and infection caused by hepatitis B virus MedDRA version: 17.0Level: LLTClassification code 10036897Term: Prophylactic vaccinationSystem Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 17.0Level: HLGTClassification code 10043413Term: Therapeutic procedures and supportive care NECSystem Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 17.0Level: PTClassification code 10021430Term: ImmunisationSystem Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 17.0Level: HLTClassification code 10021431Term: ImmunisationsSystem Organ Class: 10042613 - Surgical and medical procedures Therapeutic area: Diseases [C] - Virus Diseases [C02]

DrugsHexacima

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Prevention of infections caused by Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, poliovirus type 1, 2 and 3, prevention against invasive infections caused by Haemophilus influenzae type b and infection caused by hepatitis B virus
Sponsor: Sanofi Pasteur SA
Enrollment: 795
Status: Active, not recruiting
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 14, 2013

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Sanofi Pasteur SA

Eligibility Criteria

Inclusion Criteria

•An individual must fulfill all of the following criteria in order to be eligible for trial enrollment:
•1\) Aged 55 to 75 days on the day of the first study visit
•2\) Born at full term of pregnancy (\= 37 weeks) and/or with a birth weight \= 2\.5 kg
•3\) Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative (and by an independent witness if required by local regulations)
•4\) Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
•5\) Covered by health insurance, if applicable
•Group 3 only
•6\) Previously vaccinated with one dose of hepatitis B vaccine
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 795

Exclusion Criteria

•An individual fulfilling any of the following criteria is to be excluded from trial enrollment:
•1\) Participation at the time of study enrollment (or in the 4 weeks preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
•2\) Receipt of any vaccine in the 4 weeks preceding the first trial vaccination or planned receipt of any vaccine in the 4 weeks following any trial vaccination, except in case of routine vaccines to be administered as per the National Immunization schedule and for influenza vaccination. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines
•3\) Groups 1 and 2 only: Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Haemophilus influenzae type b, pneumococcal infections, and rotavirus with another vaccine(s)
•4\) Group 3 only: Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b, pneumococcal and meningococcal infections, and rotavirus with another vaccine(s)
•5\) Receipt of immune globulins, blood or blood\-derived products since birth
•6\) Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti\-cancer chemotherapy or radiation therapy, since birth; or long\-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks since birth)
•7\) Known personal or maternal history of hepatitis B (HBsAg) or hepatitis C seropositivity
•8\) History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Haemophilus influenzae type b and pneumococcal infections, confirmed either clinically, serologically, or microbiologically
•9\) Known systemic hypersensitivity to any of the vaccine components, or history of a life\-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances