Immunogenicity and Safety of Pentaxim in South African Infants.

• 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: EUCTR2015-005354-35-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: 212

Inclusion Criteria

1) At Visit 01 (screening)
1) Aged < 24 hours 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
Are the trial subjects under 18? yes
Number of subjects for this age range: 212
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

At visit 01( screening):
1) Illness at a stage that could interfere with trial conduct or completion.
2) Any vaccination preceding the trial participation (except BCG)
3) Acute illness on the day of screening.

At visit 01 and visit 02 (screening & first study vaccination):
4) Planned participation in another clinical trial during the present trial period
5) Blood or blood–derived products received since birth.
6) Mother known as seropositive to HIV or Hepatitis B.
7) Known thrombocytopenia or a bleeding disorder contraindicating intramuscular
vaccination
8) History of/current seizures

At visit 02 (first study vaccination):
9) Participation in another clinical trial preceding the first trial vaccination
10) Congenital or acquired immunodeficiency, immunosuppressive therapy such as
long-term systemic corticosteroids therapy
11) Systemic hypersensitivity to any of the vaccine components or history of a lifethreatening
reaction to the trial vaccine or a vaccine containing the same substances
12) Chronic illness at a stage that could interfere with trial conduct or completion.
13) Any vaccination preceding the first trial vaccination (except BCG)
14) History of diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae
type b and hepatitis B infection (confirmed either clinically, serologically or
microbiologically).
15) Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis
Haemophilus influenzae type b and hepatitis B infection with the trial vaccine or
another vaccine.
16) Febrile illness (rectal temperature = 38.0°C or axillary temperature = 37.4°C) or
acute illness on the day of first vaccination

Study & Design

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