DTaP-IPV-Hep B-PRP~T Combined Vaccine Versus DTaP-IPV//PRP~T Combined Vaccine + Hep B Vaccine in Hep B Primed Infants

• ClinicalTrials.gov Identifier: NCT02094833
• Recruitment Status: Completed
• First Posted: March 24, 2014
• Last Update Posted: April 26, 2017
• Sponsor: Sanofi Pasteur, a Sanofi Company
• Information provided by (Responsible Party): Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information

• First Submitted Date: March 20, 2014
• First Posted Date: March 24, 2014
• Last Update Posted Date: April 26, 2017
• Actual Study Start Date: March 2014
• Actual Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 20, 2014)

• Number of participants with anti-Diphtheria antibody concentrations ≥ 0.01 International Units (IU)/mL [ Time Frame: 1 month post third vaccination ]
  Anti-Diphtheria antibodies will be measured by a toxin neutralization test
• Number of participants with anti-Tetanus antibody concentrations ≥ 0.1 International unit (IU)/mL [ Time Frame: 1 month post third vaccination ]
  Anti-Tetanus antibodies will be measured by enzyme-linked immunosorbent assay (ELISA).
• Number of participants with ≥ 4 fold increase in anti-PT and anti-FHA antibody concentrations (EU/mL) from 1 month pre-dose 1 to 1 month post-dose 3 [ Time Frame: I month post dose 3 ]
  Anti-PT and anti-FHA antibodies will be measured by enzyme-linked immunosorbent assay (ELISA).

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 20, 2014)

• Number of participants with anti-Diphtheria antibody concentrations ≥ 0.01 IU/mL and ≥ 0.1 IU/mL International Units (IU)/mL [ Time Frame: Day 0 Pre-vaccination ]
  Anti-Diphtheria antibodies will be measured by a toxin neutralization test
• Number of participants with anti-Hepatitis B antibody concentrations ≥ 10 mIU/mL international unit (IU)/mL [ Time Frame: Day 0 Pre-vaccination ]
  Anti-Hepatitis B antibodies will be measured by the commercially available VITROS ECi/ECiQ Immunodiagnostic System using chemiluminescence detection technology
• Number of participants with anti Diphtheria antibody concentrations ≥ 0.1 IU/mL International Units (IU)/mL [ Time Frame: 1 month post third vaccination ]
  Anti-Diphtheria antibodies will be measured by a toxin neutralization test
• Number of participants reporting solicited injection site and solicited systemic reactions, unsolicited adverse events, and serious adverse events following vaccination with either DTaP-IPV-Hep B-PRP~T combined vaccine or Pentaxim™ and Euvax B® vaccine [ Time Frame: Day 0 and up to Day 180 post-vaccination ]
  Solicited injection site reactions Tenderness, Erythema, and Swelling. Solicited systemic reactions Fever (temperature), Vomiting, Crying abnormal, Drowsiness, Appetite loss, and Irritability.
• Number of participants with response to vaccine Pertussis toxoid (PT) and Filamentous Haemagglutinin (FHA) antigens [ Time Frame: 1 month post third vaccination ]
  Vaccine response defined as: Post-dose 3 anti-PT and anti-FHA antibody concentrations in ELISA units (EU)/mL ≥ 4 x Lower Limit of Quantitation (LLOQ) if pre-vaccination concentration is < 4 x LLOQ or ≥ pre-vaccination concentration if pre-vaccination concentrations ≥ 4 x LLOQ

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: DTaP-IPV-Hep B-PRP~T Combined Vaccine Versus DTaP-IPV//PRP~T Combined Vaccine + Hep B Vaccine in Hep B Primed Infants
• Official Title: Immunogenicity and Safety of Sanofi Pasteur's DTaP-IPV-Hep B-PRP~T Combined Vaccine at 2, 4, and 6 Months of Age Versus Sanofi Pasteur's DTaP IPV//PRP~T Combined Vaccine at 2, 4, and 6 Months of Age + Hep B Vaccine at 1 and 6 Months of Age, in South Korean Infants Primed With Hep B at Birth

Brief Summary

The aim of this study is to evaluate the immunogenicity and safety of a novel DTaP-IPV-Hep B-PRP~T fully liquid combined hexavalent vaccine (study vaccine) administered at 2, 4, and 6 months of age compared to Sanofi Pasteur's DTaP-IPV//PRP~T combined vaccine (Pentaxim™) given at 2, 4, and 6 months of age and Hep B vaccine (Euvax B®) given at 1 and 6 months of age in South Korean infants that received a birth dose of Hep B and born to mothers documented to be serum anti-HBs Ag negative.

Primary Objective

• To demonstrate the non-inferiority in terms of seroprotection (Diphtheria, Tetanus, poliovirus types 1, 2, and 3, PRP-T, Hep B) and vaccine response for pertussis antigens (pertussis toxoid [PT] and filamentous haemagglutinin [FHA]) of Group A versus Group B, one month after the third dose of combined vaccines.

Secondary Objectives:

• To further study the immunogenicity of the two vaccination schemes, before the first dose and one month after the last dose of vaccines.
• To study the safety after each and any dose of vaccines administered in the two vaccination schemes

• Detailed Description: Study participants who received a first dose of recombinant Hep B vaccine at birth will receive either DTaP-IPV-Hep B-PRP~T combined vaccine at 2, 4, and 6 months of age + 3 doses of Hep B vaccine or Hep B vaccine (Euvax B®) at 1 and 6 months of age and DTaP IPV//PRP~T combined vaccine (Pentaxim™) at 2, 4, and 6 months of age, according to the official vaccination schedule for Hep B, DTaP, poliovirus, and Hib vaccinations in South Korea.
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

• Diphtheria
• Tetanus
• Pertussis
• Haemophilus Influenzae Type b Infection
• Poliomyelitis
• Hepatitis B

Intervention

• Biological: DTaP-IPV-Hep B-PRP~T combined vaccine
  0.5 mL, Intramuscular
• Biological: DTaP-IPV//PRP~T and Hepatitis B vaccine
  0.5 mL, Intramuscular
  Other Names:

  • Pentaxim™
  • Euvax B®

Study Arms

• Experimental: Group A
  Participants will receive 3 injections of the study vaccine (DTaP-IPV-Hep B-PRP~T combined vaccine) at 2, 4, and 6 months of age
  Intervention: Biological: DTaP-IPV-Hep B-PRP~T combined vaccine
• Active Comparator: Group B
  Participants will receive 2 injections of monovalent Hep B vaccine (Euvax B®) at age 1 and 6 months and 3 injections of DTaP IPV//PRP~T vaccine (Pentaxim™) at age 2, 4, and 6 months
  Intervention: Biological: DTaP-IPV//PRP~T and Hepatitis B vaccine

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 16, 2016): 310
• Original Estimated Enrollment (submitted: March 20, 2014): 458
• Actual Study Completion Date: November 2016
• Actual Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Aged 30 to 40 days on the day of the first study visit
• Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg
• Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative
• Participant and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
• Born to known hepatitis B surface antigen (HBsAg) seronegative mother (documented laboratory result of HBsAg assay from the maternal blood sample is available)
• Have received one documented dose of Hep B vaccine at birth according to the national recommendations.

Exclusion Criteria:

• Participation in the 4 weeks preceding the trial inclusion or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
• Receipt of any vaccine in the 4 weeks preceding any trial vaccination (except Bacille Calmette Guerin (BCG) vaccine) or planned receipt of any vaccine in the 8 days following any trial vaccination
• Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B (except the dose of Hep B vaccine given at birth) diseases or Haemophilus influenzae type b infection with either the trial vaccine or another vaccine
• Past or current receipt of immune globulins, blood or blood-derived products or planned administration during the trial
• 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 corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks since birth)
• Known personal or maternal history of Human Immunodeficiency Virus (HIV) or hepatitis C seropositivity
• History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Haemophilus influenzae type b infection, confirmed either clinically, serologically, or microbiologically
• Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances
• Known thrombocytopenia, as reported by the parent/legally acceptable representative
• Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
• In an emergency setting, or hospitalized involuntarily
• Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
• Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
• Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
• History of seizures.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 1 Month to 6 Months (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT02094833
• Other Study ID Numbers: A3L31; U1111-1127-6896 ( Other Identifier: WHO )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
• Original Responsible Party: Same as current
• Current Study Sponsor: Sanofi Pasteur, a Sanofi Company
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Medical Director; Sanofi Pasteur SA

• PRS Account: Sanofi
• Verification Date: April 2017