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

Launched by SANOFI PASTEUR, A SANOFI COMPANY · Dec 9, 2011

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• 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.