Safety of the DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM®) Given as a Three-Dose Primary Vaccination at 2, 3, and 4 Months of Age in Infants in China

SANOFI PASTEUR SA0 sites900 target enrollmentDecember 4, 2015

ConditionsHealthy 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]

DrugsPENTAXIM™

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Healthy 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)
Sponsor: SANOFI PASTEUR SA
Enrollment: 900
Status: Active, not recruiting
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 4, 2015

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

SANOFI PASTEUR SA

Eligibility Criteria

Inclusion Criteria

•An individual must fulfill all of the following criteria in order to be eligible for trial enrollment:
•1\) Aged 2 months (60 to 74 days) inclusive 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
•3\) Subject and parent/legally acceptable representative are 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: 900
•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

•An individual fulfilling any of the following criteria is to be excluded from trial enrollment:
•1\) Participation or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
•2\) Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti\-cancer chemotherapy or radiation therapy since birth, or long\-term systemic corticosteroids therapy (prednisone or equivalent for more than 2 consecutive weeks since birth)
•3\) Known systemic hypersensitivity to any of the vaccine components, or history of a life\-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
•4\) Clinically significant illness, according to investigator judgment, at a stage that could interfere with trial conduct or completion
•5\) Evolving encephalopathy
•6\) Receipt of immune globulins, blood or blood–derived products since birth
•7\) Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis diseases or Haemophilus influenzae type b infection
•8\) Receipt of any other vaccine in the 14 days preceding the first trial vaccination or planned receipt of any vaccine in the 14 days following the first trial vaccination
•9\) Acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (axillary temperature \=37\.1°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided.