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

Sanofi Pasteur, a Sanofi Company0 sites900 target enrollmentDecember 2011

ConditionsDiphtheria Tetanus Pertussis Polio

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Diphtheria
Sponsor: Sanofi Pasteur, a Sanofi Company
Enrollment: 900
Primary Endpoint: Description of the Safety profile in terms of solicited injection site and systemic reaction, and serious adverse events after each vaccination with PENTAXIM® vaccine
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2011

End Date

December 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sanofi Pasteur, a Sanofi Company

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Description of the Safety profile in terms of solicited injection site and systemic reaction, and serious adverse events after each vaccination with PENTAXIM® vaccine

Time Frame: Day 0 for up to 3 months post vaccination

Solicited injection site: Tenderness, Redness, and Swelling. Solicited Systemic reaction: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of Appetite, and Irritability