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

Tetanus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01491087
• Other study ID #: E2I60
• Secondary ID: U1111-1117-7233
• Status: Completed
• Phase: Phase 4
• First received: December 9, 2011
• Last updated: March 28, 2013
• Start date: December 2011
• Est. completion date: December 2012

Study information

• Verified date: March 2013
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 900
• Est. completion date: December 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Days to 74 Days

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diphtheria
• Pertussis
• Polio
• Tetanus

Intervention

Biological:
• DTacP IPV//PRP~T combined vaccine: PENTAXIM®
0.5 mL, Intramuscular

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Description of the Safety profile in terms of solicited injection site and systemic reaction, and serious adverse events after each vaccination with PENTAXIM® vaccine	Solicited injection site: Tenderness, Redness, and Swelling. Solicited Systemic reaction: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of Appetite, and Irritability	Day 0 for up to 3 months post vaccination	No

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