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

• ClinicalTrials.gov Identifier: NCT01491087
• Recruitment Status: Completed
• First Posted: December 13, 2011
• Last Update Posted: March 29, 2013
• Sponsor: Sanofi Pasteur, a Sanofi Company
• Information provided by (Responsible Party): Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Description

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.

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

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 900 participants
• Allocation: N/A
• 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
• Study Start Date: December 2011
• Actual Primary Completion Date: July 2012
• Actual Study Completion Date: December 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: PENTAXIM® vaccine group	Biological: DTacP IPV//PRP~T combined vaccine: PENTAXIM®; 0.5 mL, Intramuscular; Other Name: PENTAXIM®

Outcome Measures

Primary Outcome Measures :

1. 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

Eligibility Criteria

• 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

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:

Related Info 

• Responsible Party: Sanofi Pasteur, a Sanofi Company
• ClinicalTrials.gov Identifier: NCT01491087
• Other Study ID Numbers: E2I60; U1111-1117-7233 ( Other Identifier: WHO )
• 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; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Gram-Positive Bacterial Infections; Corynebacterium Infections; Actinomycetales Infections