A Study of DTaP//PRP-T Combined Vaccine (ACTACEL) Versus Local DTaP and Act-HIB Monovalent Vaccine in Healthy Infants

December 12, 2011 updated by: Sanofi

Safety and Immunogenicity of the Sanofi Pasteur's DTaP//PRP-T Combined Vaccine (ACTACEL) Versus Local DTaP and Hib Conjugate (Act-HIB) Monovalent Vaccine as a Three-dose Primary and Booster Vaccination in Healthy Infants in China

The purpose of this study is to assess the immunogenicity and safety of ACTACEL combined vaccine in support of registration of this product in China

Primary Objectives:

  • To demonstrate that ACTACEL vaccine administered at 2, 3 and 4 months of age or at 3, 4 and 5 months of age is not inferior, in terms of seroprotection, to Wuhan's Diphtheria, Tetanus, acellular Pertussis (DTaP) and Haemophilus influenzae type b (Act-HIB) vaccine given concomitantly, for diphtheria, tetanus, and Polyribosyl Ribitol Phosphate (PRP) antigens, one month after the three-dose primary vaccination.
  • To demonstrate the superiority, in terms of seroconversion, of ACTACEL vaccine administered at 2, 3 and 4 months of age or at 3, 4 and 5 months of age for Pertussis Toxoid (PT), Fimbriae types 2 and 3 (FIM2) and (FIM3) pertussis antigens, compared with Wuhan's DTaP and Act-HIB vaccines given concomitantly, one month after the three-dose primary vaccination.

Secondary Objectives:

  • To describe the safety after administration of the study vaccines.
  • To describe in each group the immunogenicity of the study vaccines one month after the primary vaccination and before and one month after the booster vaccination.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants will receive a primary vaccination consisting of three doses of ACTACEL at either 2, 3, and 4 months of age or at 3, 4, and 5 months of age; or Wuhan DTaP and Act-HIB vaccines at 3, 4, and 5 months of age. All participants will receive a single booster dose at 18-20 months of age and will be followed up for one month after the last dose of study vaccine.

Study Type

Interventional

Enrollment (Actual)

1056

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangxi
      • LingChuan County, Guilin City, Guangxi, China, 541200
      • Lipu County, Guilin City, Guangxi, China, 546600

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 on the day of inclusion
  • Born at full term pregnancy (≥ 36 weeks) with a birth weight ≥ 2.5 kg
  • Informed consent form signed by the parent(s) or legal representative
  • Participant and parent/legal representative able to attend all scheduled visits and to comply with all trial procedures

Exclusion Criteria :

  • Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
  • Planned participation in another clinical trial during the present trial period
  • Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy since birth, or long-term systemic corticosteroids therapy
  • Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances
  • Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator
  • Receipt of blood or blood-derived products since birth that might interfere with the assessment of immune response
  • Receipt or planned receipt of any vaccine in the 4 weeks preceding or following any trial vaccination (except oral poliovirus (OPV), bacillus Calmette-Guérin (BCG), and Hepatitis B vaccines which cannot be given within 8 days before or after any study vaccination)
  • History of seizures
  • Known personal or maternal Human Immunodeficiency Virus (HIV), Hepatitis B (HB) surface antigen or Hepatitis C seropositivity
  • History of diphtheria, tetanus, pertussis or Haemophilus influenzae type b infection (confirmed either clinically, serologically or microbiologically)
  • Previous vaccination against diphtheria, tetanus, pertussis or Haemophilus influenzae type b disease with either the trial vaccine or another vaccine
  • Participant at high risk for diphtheria, tetanus, pertussis or Haemophilus influenzae type b infection during the trial
  • Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular vaccination
  • History of contraindication to vaccination with pertussis-containing vaccine
  • Febrile illness (axillary temperature ≥37.1°C) or moderate or severe acute illness/infection on the day of inclusion, according to Investigator judgment

Temporary contraindications that must be resolved before vaccination:

  • Acute febrile illness within the 72 hours preceding the vaccination, or temperature ≥37.1°C present at this visit
  • Any vaccination in the 4 weeks preceding the vaccination (except OPV, BCG, and hepatitis B vaccines which cannot be given within 8 days before or after any study vaccination)
  • Systemic corticosteroids therapy (prednisone or equivalent) for more than 2 consecutive weeks within the past 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Group 1
Participants will receive ACTACEL vaccine at 2, 3, and 4 months of age.
Biological: DTaP//PRP-T Combined Vaccine
0.5 mL, Intramuscular
Other Names:
  • ACTACEL
Experimental: Study Group 2
Participants will receive ACTACEL vaccine at 3, 4, and 5 months of age.
Biological: DTaP//PRP-T Combined Vaccine
0.5 mL, Intramuscular
Other Names:
  • ACTACEL
Active Comparator: Study Group 3
Participants will receive Wuhan DTaP and Act-HIB vaccines concomitantly at 3, 4 and 5 months of age.
Biological: DTaP Combined Vaccine and PRP-Tetanus Conjugate Vaccine
0.5 mL, Intramuscular (each vaccine)
Other Names:
  • Act-HIB™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Immunogenicity: To provide information concerning the immunogenicity of ACTACEL vaccine after primary and booster vaccination.
Time Frame: One month post-vaccination
One month post-vaccination

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety: To provide information concerning the safety after primary and booster administration of ACTACEL vaccine.
Time Frame: 0-7 days post-vaccination and entire study duration
0-7 days post-vaccination and entire study duration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

February 3, 2010

First Submitted That Met QC Criteria

February 3, 2010

First Posted (Estimate)

February 4, 2010

Study Record Updates

Last Update Posted (Estimate)

December 13, 2011

Last Update Submitted That Met QC Criteria

December 12, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C5A06
  • UTN: U1111-1112-2509 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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