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

Launched by SANOFI PASTEUR, A SANOFI COMPANY · Nov 7, 2013

Keywords

ClinConnect Summary

No investigational vaccine will be administered in the study. Subjects who were previously randomized and completed the primary series, Study A3L24 and the booster study A3L27 will be invited to take part in this study.

Any serious adverse events (SAEs) related to the vaccines administered during the preceding trial (A3L27;) and SAEs related to A3L28 study procedures will be collected throughout the trial.

No vaccine will be administered as part of this study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Aged 3 years and a half (42 months ± 60 days) on the day of the first study visit
• • 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)
• • Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
• • Receipt of primary vaccination with 3 doses of investigational vaccines during the primary series trial A3L24 (either DTaP-IPV-Hep B-PRP-T or Infanrix hexa, concomitantly administered with Prevenar \[PCV7\] and Rotarix) and a booster dose during the trial A3L27 (either DTaP-IPV-Hep B-PRP-T or Infanrix hexa, concomitantly administered with Prevenar \[PCV7\]).
• Exclusion Criteria:
• • 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
• • Incomplete primary and booster immunization at trial A3L24 and A3L27
• • 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
• • Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Haemophilus influenzae type b infections with other vaccine(s) after completion of A3L27 study
• • Receipt of immune globulins, blood or blood-derived products in the past 3 months
• • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 3 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
• • History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Haemophilus influenzae type b infection(s), confirmed either clinically, serologically, or microbiologically after completion of trial A3L27
• • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating blood drawn
• • Acute or chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion.