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:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01491087
First received: December 9, 2011
Last updated: March 28, 2013
Last verified: March 2013
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   60 Days to 74 Days
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01491087     History of Changes
Other Study ID Numbers: E2I60, U1111-1117-7233
Study First Received: December 9, 2011
Last Updated: March 28, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Sanofi:
Pentaxim®
Whole-cell Pertussis vaccine
Acellular Pertussis vaccine
Haemophilus influenzae type b polysaccharide
Inactivated Polio vaccine
Pentavac®

Additional relevant MeSH terms:
Diphtheria
Whooping Cough
Poliomyelitis
Tetanus
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Myelitis
Central Nervous System Viral Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Clostridium Infections

ClinicalTrials.gov processed this record on August 21, 2014