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

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

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.

Study Overview

• Status: Completed
• Conditions: Pertussis; Tetanus; Diphtheria; Polio
• Intervention / Treatment: Biological: DTacP IPV//PRP~T combined vaccine: 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.

• Study Type: Interventional
• Enrollment (Actual): 900
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200336
  • Tianjin, China, 300011
  • Guangdong
    • Guangzhou, Guangdong, China, 510300

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 2 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PENTAXIM® vaccine group	Biological: DTacP IPV//PRP~T combined vaccine: PENTAXIM®; 0.5 mL, Intramuscular; Other Names: PENTAXIM®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sanofi Pasteur, a Sanofi Company

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: December 9, 2011
• First Submitted That Met QC Criteria: December 9, 2011
• First Posted (Estimate): December 13, 2011

Study Record Updates

• Last Update Posted (Estimate): March 29, 2013
• Last Update Submitted That Met QC Criteria: March 28, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: Pentaxim®; Whole-cell Pertussis vaccine; Acellular Pertussis vaccine; Haemophilus influenzae type b polysaccharide; Inactivated Polio vaccine; Pentavac®
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Corynebacterium Infections; Whooping Cough; Diphtheria
• Other Study ID Numbers: E2I60; U1111-1117-7233 (Other Identifier: WHO)