Immunogenicity and Safety Study of a Booster Dose of DTaP-IPV-Hep B-PRP-T Combined Vaccine at 15 to 18 Months of Age Following a Primary Series at 2, 3 and 4 Months of Age in Healthy Turkish Infants

• Conditions: Prevention of infections caused by Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, poliovirus types 1, 2 and 3, prevention against invasive infections caused by Haemophilus influenzae type b and infection caused by hepatitis B virus; MedDRA version: 14.1Level: PTClassification code 10021430Term: ImmunisationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 14.1Level: LLTClassification code 10036897Term: Prophylactic vaccinationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 14.1Level: HLTClassification code 10021431Term: ImmunisationsSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 14.1Level: HLGTClassification code 10043413Term: Therapeutic procedures and supportive care NECSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-004432-58-Outside-EU/EEA
• Lead Sponsor: Sanofi Pasteur SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-10
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 254

Inclusion Criteria

1) Toddler previously included in Study A3L10 who completed the three dose primary series vaccination of either DTaP-IPV-Hep B-PRP-T or Pentaxim™ and Engerix™ B at 2, 3, and 4 months of age
2) Toddler of 15 to 18 months of age (range: 456 to 578 days of age inclusive)
3) Informed Consent Form signed by the parent(s) or other legal representative(s) and an institution official other than an Investigator
4) Able to attend all scheduled visits and to comply with all trial procedures
Are the trial subjects under 18? yes
Number of subjects for this age range: 254
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

1) Participation in another clinical trial in the 4 weeks preceding the booster vaccination
2) Planned participation in another clinical trial during the present trial period
3) Congenital or acquired immunodeficiency, and immunosuppressive therapy such as long term systemic corticosteroid therapy
4) Systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to a vaccine containing the same substances
5) Chronic illness at a stage that could interfere with trial conduct or completion
6) Blood or blood derived products received in the last 3 months
7) Any vaccination in the 4 weeks preceding the booster vaccination
8) Any vaccination planned until Visit 02
9) History of documented pertussis, tetanus, diphtheria, polio, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically)
10) Previous booster vaccination against pertussis, tetanus, diphtheria, polio or Haemophilus influenzae type b, and hepatitis B infection(s)
11) Coagulopathy, thrombocytopenia, or a bleeding disorder contraindicating intramuscular vaccination
12) Any vaccine related SAE that occurred following the three dose primary series administration of the investigational vaccine or of the reference vaccine in Study A3L10
13) Febrile (temperature > or =38.0°C) or acute illness on the day of inclusion
14) Known contraindication to further vaccination with a pertussis vaccine, i.e.
- Encephalopathy
- Temperature >40.0°C within 48 hours following a vaccine injection, not due to another identifiable cause during the primary series
- Inconsolable crying that occurred for >3 hours within 48 hours following vaccine injection during the primary series
- Hypotonic hyporesponsive episode within 48 hours following vaccine injection during the primary series
- Seizures with or without fever within 3 days following vaccine injection

Study & Design

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