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

NCT02094833 | Completed Phase 3

• 2 other identifiers: A3L31U1111-1127-6896
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 16

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

Conditions

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

Keywords

Diphtheria; Tetanus; Pertussis; Haemophilus influenzae type b infection; Hepatitis B; DTaP-IPV-Hep - PRP-T vaccine

Outcome Measures

Primary Outcomes (3)

• Number of participants with anti-Diphtheria antibody concentrations ≥ 0.01 International Units (IU)/mL

  Anti-Diphtheria antibodies will be measured by a toxin neutralization test

  1 month post third vaccination

• Number of participants with anti-Tetanus antibody concentrations ≥ 0.1 International unit (IU)/mL

  Anti-Tetanus antibodies will be measured by enzyme-linked immunosorbent assay (ELISA).

  1 month post third vaccination

• 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

  Anti-PT and anti-FHA antibodies will be measured by enzyme-linked immunosorbent assay (ELISA).

  I month post dose 3

Secondary Outcomes (5)

• Number of participants with anti-Diphtheria antibody concentrations ≥ 0.01 IU/mL and ≥ 0.1 IU/mL International Units (IU)/mL

  Day 0 Pre-vaccination

• Number of participants with anti-Hepatitis B antibody concentrations ≥ 10 mIU/mL international unit (IU)/mL

  Day 0 Pre-vaccination

• Number of participants with anti Diphtheria antibody concentrations ≥ 0.1 IU/mL International Units (IU)/mL

  1 month post third vaccination

• 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

  Day 0 and up to Day 180 post-vaccination

• Number of participants with response to vaccine Pertussis toxoid (PT) and Filamentous Haemagglutinin (FHA) antigens

  1 month post third vaccination

Study Arms (2)

Group A

EXPERIMENTAL

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

Biological: DTaP-IPV-Hep B-PRP~T combined vaccine

Group B

ACTIVE COMPARATOR

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

Biological: DTaP-IPV//PRP~T and Hepatitis B vaccine

Interventions

DTaP-IPV-Hep B-PRP~T combined vaccine BIOLOGICAL

0.5 mL, Intramuscular

Group A

DTaP-IPV//PRP~T and Hepatitis B vaccine BIOLOGICAL

0.5 mL, Intramuscular

Also known as: Pentaxim™, Euvax B®

Group B

Eligibility Criteria

• Age: 1 Month - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (16)

Unknown Facility

Daejeon, 301 724, South Korea

Location

Unknown Facility

Gyeonggi-do, 425 707, South Korea

Location

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Gyeonggi-do, South Korea

Location

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Gyeongsangnam Do, 641 560, South Korea

Location

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Gyeongsangnam Do, South Korea

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Jeollabuk Do, 570 711, South Korea

Location

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Jeonbuk, 561 712, South Korea

Location

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Kangwon Do, 220 701, South Korea

Location

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Kyunggi Do, 420 717, South Korea

Location

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Seoul, 120 752, South Korea

Location

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Seoul, 130 87, South Korea

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Unknown Facility

Seoul, 137 701, South Korea

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Seoul, 139 709, South Korea

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Seoul, 158 710, South Korea

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Unknown Facility

Seoul, South Korea

Location

Unknown Facility

Suwon Gyeonggi Do, 442 723, South Korea

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Related Links

• Related Info

MeSH Terms

Conditions

Diphtheria; Tetanus; Whooping Cough; Haemophilus Infections; Poliomyelitis; Hepatitis B

Interventions

Hepatitis B Vaccines; Pentavac; Euvax-B

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; Myelitis; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases; Blood-Borne Infections; Communicable Diseases; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Viral Hepatitis Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Medical Director

  Sanofi Pasteur SA

  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: March 20, 2014
• First Posted: March 24, 2014
• Study Start: March 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: November 1, 2016
• Last Updated: April 26, 2017

Record last verified: 2017-04

Locations

KR (16)