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

NCT01491087 | Completed Phase 4

• 2 other identifiers: E2I60U1111-1117-7233
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 3

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.

Conditions

Diphtheria; Tetanus; Pertussis; Polio

Keywords

Pentaxim®; Whole-cell Pertussis vaccine; Acellular Pertussis vaccine; Haemophilus influenzae type b polysaccharide; Inactivated Polio vaccine; Pentavac®

Outcome Measures

Primary Outcomes (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

  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

Study Arms (1)

PENTAXIM® vaccine group

EXPERIMENTAL

Biological: DTacP IPV//PRP~T combined vaccine: PENTAXIM®

Interventions

DTacP IPV//PRP~T combined vaccine: PENTAXIM® BIOLOGICAL

0.5 mL, Intramuscular

Also known as: PENTAXIM®

PENTAXIM® vaccine group

Eligibility Criteria

• Age: 60 Days - 74 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (3)

Unknown Facility

Guangzhou, Guangdong, 510300, China

Location

Unknown Facility

Shanghai, 200336, China

Location

Unknown Facility

Tianjin, 300011, China

Location

Related Links

• Related Info

MeSH Terms

Conditions

Diphtheria; Tetanus; Whooping Cough; Poliomyelitis

Interventions

Pentavac

Condition Hierarchy (Ancestors)

Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Clostridium Infections; Bordetella Infections; Gram-Negative Bacterial Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Myelitis; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases

Study Officials

• Medical Director

  Sanofi Pasteur SA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2011
• First Posted: December 13, 2011
• Study Start: December 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 29, 2013

Record last verified: 2013-03

Locations

CN (3)