Clinical trial NCT01491087: Safety of PENTAXIM® Given as a Three-Dose Primary Vaccination at 2, 3, and 4 Months of Age in Infants in China
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diphtheria
Tetanus
Pertussis
Polio
Keywords: Pentaxim®
Whole-cell Pertussis vaccine
Acellular Pertussis vaccine
Haemophilus influenzae type b polysaccharide
Inactivated Polio vaccine
Pentavac®
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2011-12-13
Enrollment: 900
Sex: ALL
Minimum age (years): 60
Maximum age (years): 74
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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 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.

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 trial will be approximately 3 to 4 months.

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.

Primary outcomes:
measure: Description of the Safety profile in terms of solicited injection site and systemic reaction, and serious adverse events after each vaccination with PENTAXIM® vaccine
timeFrame: Day 0 for up to 3 months post vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
state: Guangdong
city: Shanghai
country: China
city: Tianjin
country: China
Study officials:
affiliation: Sanofi Pasteur SA
name: Medical Director
role: STUDY_DIRECTOR
References: