Safety of PENTAXIM® Given as a Three-Dose Primary Vaccination at 2, 3, and 4 Months of Age in Infants in China
NCT ID: NCT01491087
Last Updated: 2013-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
900 participants
INTERVENTIONAL
2011-12-31
2012-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Primary Objective
* To describe the safety after administration of PENTAXIM® at 2, 3, and 4 months of age in the study population.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The duration of each participant in the trial will be approximately 3 to 4 months.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PENTAXIM® vaccine group
DTacP IPV//PRP~T combined vaccine: PENTAXIM®
0.5 mL, Intramuscular
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
DTacP IPV//PRP~T combined vaccine: PENTAXIM®
0.5 mL, Intramuscular
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
60 Days
74 Days
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Director
Role: STUDY_DIRECTOR
Sanofi Pasteur SA
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Guangzhou, Guangdong, China
Shanghai, , China
Tianjin, , China
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
U1111-1117-7233
Identifier Type: OTHER
Identifier Source: secondary_id
E2I60
Identifier Type: -
Identifier Source: org_study_id