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

NCT01062477 | Completed Phase 3

• 2 other identifiers: C5A06UTN: U1111-1112-2509
• Study Type: interventional
• Target: 1,056
• Locations: 1 country
• Sites: 2

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.

Conditions

Diphtheria; Tetanus; Pertussis; Haemophilus Influenzae Type B

Keywords

Diphtheria Tetanus Pertussis Haemophilus Influenzae Type B

Outcome Measures

Primary Outcomes (1)

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

  One month post-vaccination

Secondary Outcomes (1)

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

  0-7 days post-vaccination and entire study duration

Study Arms (3)

Study Group 1

EXPERIMENTAL

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

Biological: DTaP//PRP-T Combined Vaccine

Study Group 2

EXPERIMENTAL

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

Biological: DTaP//PRP-T Combined Vaccine

Study Group 3

ACTIVE COMPARATOR

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

Interventions

DTaP//PRP-T Combined Vaccine BIOLOGICAL

0.5 mL, Intramuscular

Also known as: ACTACEL

Study Group 1

DTaP Combined Vaccine and PRP-Tetanus Conjugate Vaccine BIOLOGICAL

0.5 mL, Intramuscular (each vaccine)

Also known as: Act-HIB™

Study Group 3

Eligibility Criteria

• Age: 60 Days - 89 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• History of contraindication to vaccination with pertussis-containing vaccine
• 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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (2)

Unknown Facility

LingChuan County, Guilin City, Guangxi, 541200, China

Location

Unknown Facility

Lipu County, Guilin City, Guangxi, 546600, China

Location

Related Links

• Related Info

MeSH Terms

Conditions

Diphtheria; Tetanus; Whooping Cough; Haemophilus Infections

Interventions

Hiberix

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; Pasteurellaceae Infections

Study Officials

• Medical Director

  Sanofi Pasteur Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2010
• First Posted: February 4, 2010
• Study Start: January 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 13, 2011

Record last verified: 2011-12

Locations

CN (2)