Immunogenicity and Safety of Sanofi Pasteur Pentaxim Combined Vaccine in Infants in Thailand.

• Conditions: Healty volunteers: active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive infections caused by Haemophilus influenzae type b (such as meningitis, septicaemia, cellulitis, arthritis, epiglottitis, pneumopathy, osteomyelitis); MedDRA version: 18.1Level: LLTClassification code 10036897Term: Prophylactic vaccinationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 18.1Level: HLGTClassification code 10043413Term: Therapeutic procedures and supportive care NECSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 18.1Level: PTClassification code 10021430Term: ImmunisationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 18.1Level: HLTClassification code 10021431Term: ImmunisationsSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-005352-10-Outside-EU/EEA
• Lead Sponsor: SANOFI PASTEUR INTERNATIONA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-04
• Last Update Posted: 7 December 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 186

Inclusion Criteria

1) Aged 53 to 70 days inclusive on the day of inclusion
2) Born at full term pregnancy (>37 weeks) with a birth weight = 2.5 kg
3) Informed consent form signed by the parent(s) or other legal representative
4) Able to attend all scheduled visits and to comply with all trial procedures
5) First dose of Hepatitis B vaccine received within 24 hours of birth

Are the trial subjects under 18? yes
Number of subjects for this age range: 186
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 (first) trial vaccination
2) Planned participation in another clinical trial during the present trial period
3) Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
4) Systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to the trial vaccine or 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 past.
7) Mother known as seropositive to HIV or Hepatitis B
8) Any vaccination in the 5 weeks preceding the first trial vaccination (except BCG)
9) History of diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b infection or Hepatitis B (confirmed either clinically, serologically or microbiologically).
10) Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases or Haemophilus influenzae type b infection with the trial vaccine or another vaccine.
11) Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
12) History of/current seizures
13) Febrile illness (rectal temperature = 38.0°C or axillary temperature = 37.4°C) or acute illness on the day of inclusion.

Study & Design

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