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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01491087
First Posted: December 13, 2011
Last Update Posted: March 29, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
  Purpose

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.

Condition Intervention Phase
Diphtheria Tetanus Pertussis Polio Biological: DTacP IPV//PRP~T combined vaccine: PENTAXIM® Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):

Primary Outcome Measures:
  • 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


Enrollment: 900
Study Start Date: December 2011
Study Completion Date: December 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PENTAXIM® vaccine group Biological: DTacP IPV//PRP~T combined vaccine: PENTAXIM®
0.5 mL, Intramuscular
Other Name: PENTAXIM®

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   60 Days to 74 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01491087


Locations
China, Guangdong
Guangzhou, Guangdong, China, 510300
China
Shanghai, China, 200336
Tianjin, China, 300011
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur SA
  More Information

Additional Information:
Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT01491087     History of Changes
Other Study ID Numbers: E2I60
U1111-1117-7233 ( Other Identifier: WHO )
First Submitted: December 9, 2011
First Posted: December 13, 2011
Last Update Posted: March 29, 2013
Last Verified: March 2013

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Pentaxim®
Whole-cell Pertussis vaccine
Acellular Pertussis vaccine
Haemophilus influenzae type b polysaccharide
Inactivated Polio vaccine
Pentavac®

Additional relevant MeSH terms:
Whooping Cough
Diphtheria
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs