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 )

Study Description

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

Condition or disease	Intervention/treatment	Phase
Diphtheria; Tetanus; Pertussis; Haemophilus Influenzae Type b Infection; Poliomyelitis; Hepatitis B	Biological: DTaP-IPV-Hep B-PRP~T combined vaccine; Biological: DTaP-IPV//PRP~T and Hepatitis B vaccine	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 310 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: March 2014
• Actual Primary Completion Date: April 2016
• Actual Study Completion Date: November 2016

Arms and Interventions

Arm	Intervention/treatment
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	Biological: DTaP-IPV-Hep B-PRP~T combined vaccine; 0.5 mL, Intramuscular
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	Biological: DTaP-IPV//PRP~T and Hepatitis B vaccine; 0.5 mL, Intramuscular; Other Names: Pentaxim™; Euvax B®

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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).
3. 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).

Secondary Outcome Measures :

1. 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
2. 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
3. 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
4. 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.
5. 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

Eligibility Criteria

• Ages Eligible for Study: 1 Month to 6 Months (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

Korea, Republic of

Daejeon, Korea, Republic of, 301 724

Gyeonggi do, Korea, Republic of, 425 707

Gyeonggi Do, Korea, Republic of

Gyeongsangnam do, Korea, Republic of, 641 560

Gyeongsangnam do, Korea, Republic of

Jeollabuk do, Korea, Republic of, 570 711

Jeonbuk, Korea, Republic of, 561 712

Kangwon do, Korea, Republic of, 220 701

Kyunggi Do, Korea, Republic of, 420 717

Seoul, Korea, Republic of, 120 752

Seoul, Korea, Republic of, 130 87

Seoul, Korea, Republic of, 137 701

Seoul, Korea, Republic of, 139 709

Seoul, Korea, Republic of, 158 710

Seoul, Korea, Republic of

Suwon Gyeonggi do, Korea, Republic of, 442 723

Sponsors and Collaborators

Sanofi Pasteur, a Sanofi Company

Investigators

• Study Director: Medical Director; Sanofi Pasteur SA

More Information

Additional Information:

Related Info 

Related Info 

• Responsible Party: Sanofi Pasteur, a Sanofi Company
• ClinicalTrials.gov Identifier: NCT02094833
• Other Study ID Numbers: A3L31; U1111-1127-6896 ( Other Identifier: WHO )
• First Posted: March 24, 2014
• Last Update Posted: April 26, 2017
• Last Verified: April 2017

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):

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

Additional relevant MeSH terms:

Whooping Cough; Tetanus; Diphtheria; Haemophilus Infections; Hepatitis B; Poliomyelitis; Hepatitis; Infection; Liver Diseases; Digestive System Diseases; Hepatitis, Viral, Human; Virus Diseases; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Hepadnaviridae Infections; DNA Virus Infections; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Clostridium Infections; Gram-Positive Bacterial Infections; Nervous System Diseases; Corynebacterium Infections; Actinomycetales Infections; Myelitis; Central Nervous System Infections; Central Nervous System Diseases