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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01062477
First received: February 3, 2010
Last updated: December 12, 2011
Last verified: December 2011
  Purpose

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.

Condition Intervention Phase
Diphtheria
Tetanus
Pertussis
Haemophilus Influenzae Type B
Biological: DTaP//PRP-T Combined Vaccine
Biological: DTaP Combined Vaccine and PRP-Tetanus Conjugate Vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Immunogenicity: To provide information concerning the immunogenicity of ACTACEL vaccine after primary and booster vaccination. [ Time Frame: One month post-vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 1056
Study Start Date: January 2010
Study Completion Date: December 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: Act-HIB™

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.

  Eligibility

Ages Eligible for Study:   60 Days to 89 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01062477

Locations
China, Guangxi
LingChuan County, Guilin City, Guangxi, China, 541200
Lipu County, Guilin City, Guangxi, China, 546600
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01062477     History of Changes
Other Study ID Numbers: C5A06, UTN: U1111-1112-2509
Study First Received: February 3, 2010
Last Updated: December 12, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Sanofi:
Diphtheria Tetanus Pertussis Haemophilus Influenzae Type B

Additional relevant MeSH terms:
Diphtheria
Influenza, Human
Whooping Cough
Tetanus
Tetany
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Bordetella Infections
Gram-Negative Bacterial Infections
Infection
Clostridium Infections
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Hypocalcemia
Calcium Metabolism Disorders
Metabolic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014