Status:
COMPLETED
Safety of PENTAXIM® Given as a Three-Dose Primary Vaccination at 2, 3, and 4 Months of Age in Infants in China
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Diphtheria
Tetanus
Eligibility:
All Genders
60-74 years
Phase:
PHASE4
Brief Summary
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 o...
Detailed 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 tr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT01491087
Start Date
December 1 2011
End Date
December 1 2012
Last Update
March 29 2013
Active Locations (3)
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1
Guangzhou, Guangdong, China, 510300
2
Shanghai, China, 200336
3
Tianjin, China, 300011