Safety of PENTAXIM® Given as a Three-Dose Primary Vaccination at 2, 3, and 4 Months of Age in Infants in China

Sanofi

Status and phase

Completed

Phase 4

Conditions

Diphtheria

Polio

Pertussis

Tetanus

Treatments

Biological: DTacP IPV//PRP~T combined vaccine: PENTAXIM®

Study type

Interventional

Funder types

Industry

Identifiers

NCT01491087

U1111-1117-7233 (Other Identifier)

E2I60

Details and patient eligibility

About

The study will assess the safety of Pentaxim® vaccine as a three-dose primary vaccination at 2, 3, and 4 months of age in order to meet the regulatory requirements for the license renewal as for any other product registered in China, and to generate additional clinical data using the three-dose primary vaccination schedule in some other Chinese provinces.

Primary Objective

To describe the safety after administration of PENTAXIM® at 2, 3, and 4 months of age in the study population.

Full description

Each study participant will receive an injection of PENTAXIM® at 2, 3, and 4 months of age and will be monitored for safety through the entire study period.

The duration of each participant in the trial will be approximately 3 to 4 months.

Enrollment

900 patients

Sex

All

Ages

60 to 74 days old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Aged 2 months (60 to 74 days) inclusive 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
Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures.

Exclusion criteria

Participation or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
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)
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
Clinically significant illness, according to investigator judgment, at a stage that could interfere with trial conduct or completion
Evolving encephalopathy
Receipt of immune globulins, blood or blood-derived products since birth
Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis diseases or Haemophilus influenzae type b infection
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
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.
Contraindications to vaccination according to PENTAXIM® summary of product characteristics (SPC) or leaflet
In an emergency setting, or hospitalized involuntarily
Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study.