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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Diphtheria, Tetanus, Pertussis, Polio

Intervention / Treatment
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* Biological: DTacP IPV//PRP T combined vaccine: PENTAXIM®


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Days
Maximum Age: 74 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PENTAXIM® vaccine group<br> | Biological: DTacP IPV//PRP T combined vaccine: PENTAXIM®<br>* 0.5 mL, Intramuscular<br>* Other names: PENTAXIM®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of the Safety profile in terms of solicited injection site and systemic reaction, and serious adverse events after each vaccination with PENTAXIM® vaccine | Solicited injection site: Tenderness, Redness, and Swelling. Solicited Systemic reaction: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of Appetite, and Irritability | Day 0 for up to 3 months post vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pentaxim®, Whole-cell Pertussis vaccine, Acellular Pertussis vaccine, Haemophilus influenzae type b polysaccharide, Inactivated Polio vaccine, Pentavac®