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

Brief Title

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

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.
    

Study Phase

Phase 4

Study Type

Interventional

Primary Outcome

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

Condition

Diphtheria

Intervention

DTacP IPV//PRP~T combined vaccine: PENTAXIM®

Study Arms / Comparison Groups

 PENTAXIM® vaccine group

Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Biological

Estimated Enrollment

900

Start Date

December 2011

Completion Date

December 2012

Primary Completion Date

July 2012

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.
      

Gender

All

Ages

60 Days - 74 Days

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Medical Director, , 

Location Countries

China

Location Countries

China

NCT ID

NCT01491087

Organization ID

E2I60

Secondary IDs

U1111-1117-7233

Responsible Party

Sponsor

Study Sponsor

Sanofi Pasteur, a Sanofi Company

Study Sponsor

Medical Director, Study Director, Sanofi Pasteur SA

Verification Date

March 2013