search
Back to results

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

Primary Purpose

Diphtheria, Tetanus, Pertussis

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
DTaP//PRP-T Combined Vaccine
DTaP//PRP-T Combined Vaccine
DTaP Combined Vaccine and PRP-Tetanus Conjugate Vaccine
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diphtheria focused on measuring Diphtheria Tetanus Pertussis Haemophilus Influenzae Type B

Eligibility Criteria

60 Days - 89 Days (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Study Group 1

Study Group 2

Study Group 3

Arm Description

Participants will receive ACTACEL vaccine at 2, 3, and 4 months of age.

Participants will receive ACTACEL vaccine at 3, 4, and 5 months of age.

Participants will receive Wuhan DTaP and Act-HIB vaccines concomitantly at 3, 4 and 5 months of age.

Outcomes

Primary Outcome Measures

Immunogenicity: To provide information concerning the immunogenicity of ACTACEL vaccine after primary and booster vaccination.

Secondary Outcome Measures

Safety: To provide information concerning the safety after primary and booster administration of ACTACEL vaccine.

Full Information

First Posted
February 3, 2010
Last Updated
December 12, 2011
Sponsor
Sanofi
search

1. Study Identification

Unique Protocol Identification Number
NCT01062477
Brief Title
A Study of DTaP//PRP-T Combined Vaccine (ACTACEL) Versus Local DTaP and Act-HIB Monovalent Vaccine in Healthy Infants
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diphtheria, Tetanus, Pertussis, Haemophilus Influenzae Type B
Keywords
Diphtheria Tetanus Pertussis Haemophilus Influenzae Type B

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1056 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Group 1
Arm Type
Experimental
Arm Description
Participants will receive ACTACEL vaccine at 2, 3, and 4 months of age.
Arm Title
Study Group 2
Arm Type
Experimental
Arm Description
Participants will receive ACTACEL vaccine at 3, 4, and 5 months of age.
Arm Title
Study Group 3
Arm Type
Active Comparator
Arm Description
Participants will receive Wuhan DTaP and Act-HIB vaccines concomitantly at 3, 4 and 5 months of age.
Intervention Type
Biological
Intervention Name(s)
DTaP//PRP-T Combined Vaccine
Other Intervention Name(s)
ACTACEL
Intervention Description
0.5 mL, Intramuscular
Intervention Type
Biological
Intervention Name(s)
DTaP//PRP-T Combined Vaccine
Other Intervention Name(s)
ACTACEL
Intervention Description
0.5 mL, Intramuscular
Intervention Type
Biological
Intervention Name(s)
DTaP Combined Vaccine and PRP-Tetanus Conjugate Vaccine
Other Intervention Name(s)
Act-HIB™
Intervention Description
0.5 mL, Intramuscular (each vaccine)
Primary Outcome Measure Information:
Title
Immunogenicity: To provide information concerning the immunogenicity of ACTACEL vaccine after primary and booster vaccination.
Time Frame
One month post-vaccination
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Days
Maximum Age & Unit of Time
89 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Sanofi Pasteur Inc.
Official's Role
Study Director
Facility Information:
City
LingChuan County, Guilin City
State/Province
Guangxi
ZIP/Postal Code
541200
Country
China
City
Lipu County, Guilin City
State/Province
Guangxi
ZIP/Postal Code
546600
Country
China

12. IPD Sharing Statement

Links:
URL
http://www.sanofipasteur.com
Description
Related Info

Learn more about this trial

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

We'll reach out to this number within 24 hrs