Antibody Persistence at Age 3.5 and 4.5 Years After Primary and Booster DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccinatio

Conditions: Diphtheria, Tetanus, Whooping Cough, Hepatitis B, Poliomyelitis, Haemophilius Influenzae Type b
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2011-004451-39-Outside-EU/EEA

Lead Sponsor: Sanofi Pasteur Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 699

Inclusion Criteria

A potential subject had to meet all of the following criteria to be considered for trial
enrollment:
1) Aged 3 years and a half (42 months ± 60 days) on the day of the first study visit
2) Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative (and by independent witness/es if required by local regulations)
3) Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
4) Receipt of primary vaccination with 3 doses of investigational vaccines during the primary series trial A3L24 (either DTaP-IPV-HB-Hib or Infanrix™ hexa, concomitantly administered with Prevenar™ [PCV7] and Rotarix™) and a booster dose during the trial A3L27 (either DTaP-IPV-HB-Hib
Are the trial subjects under 18? yes
Number of subjects for this age range: 558
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

A potential subject meeting any of the following criteria was ineligible for trial enrollment:
1) Participation at the time of study enrollment (or in the 4 weeks preceding the first trial visit) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
2) Incomplete primary and booster immunization at trial A3L24 and A3L27
3) Receipt of any vaccine in the 4 weeks preceding the first trial visit or planned receipt of any vaccine in the 4 weeks preceding the second trial visit
4) Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Haemophilus influenzae type b infections with other vaccine(s) after completion of A3L27 study