ClinicalTrials.gov

History of Changes for Study: NCT02094833
DTaP-IPV-Hep B-PRP~T Combined Vaccine Versus DTaP-IPV//PRP~T Combined Vaccine + Hep B Vaccine in Hep B Primed Infants
Latest version (submitted April 25, 2017) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 March 20, 2014 None (earliest Version on record)
2 March 25, 2014 Study Design and Study Status
3 October 2, 2014 Study Status
4 April 22, 2015 Study Status
5 October 23, 2015 Recruitment Status, Study Status and Contacts/Locations
6 February 16, 2016 Study Status and Study Design
7 April 25, 2017 Recruitment Status and Study Status
Comparison Format:

Scroll up to access the controls

Study NCT02094833
Submitted Date:  March 20, 2014 (v1)

Open or close this module Study Identification
Unique Protocol ID: A3L31
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
Secondary IDs: U1111-1127-6896 [WHO]
Open or close this module Study Status
Record Verification: March 2014
Overall Status: Recruiting
Study Start: March 2014
Primary Completion: January 2016 [Anticipated]
Study Completion: January 2016 [Anticipated]
First Submitted: March 20, 2014
First Submitted that
Met QC Criteria:
March 20, 2014
First Posted: March 24, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
March 20, 2014
Last Update Posted: March 24, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Sanofi Pasteur, a Sanofi Company
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module 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
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.
Open or close this module Conditions
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
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 4
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 458 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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®
Open or close this module 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
Open or close this module Eligibility
Minimum Age: 1 Month
Maximum Age: 6 Months
Sex: All
Gender Based:
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.
Open or close this module Contacts/Locations
Central Contact Person: Medical Director
Email: RegistryContactUs@sanofipasteur.com
Study Officials: Medical Director
Study Director
Sanofi Pasteur SA
Locations: Korea, Republic of
[Recruiting]
Daejeon, Korea, Republic of, 301 724
[Recruiting]
Gyeonggi Do, Korea, Republic of
[Recruiting]
Gyeonggi do, Korea, Republic of, 425 707
[Recruiting]
Gyeongsangnam do, Korea, Republic of, 641 560
[Recruiting]
Gyeongsangnam do, Korea, Republic of
[Recruiting]
Jeollabuk do, Korea, Republic of, 570 711
[Recruiting]
Jeonbuk, Korea, Republic of, 561 712
[Recruiting]
Kangwon do, Korea, Republic of, 220 701
[Recruiting]
Kyunggi Do, Korea, Republic of, 420 717
[Recruiting]
Seoul, Korea, Republic of, 120 752
[Recruiting]
Seoul, Korea, Republic of, 130 87
[Recruiting]
Seoul, Korea, Republic of, 137 701
[Recruiting]
Seoul, Korea, Republic of, 139 709
[Recruiting]
Seoul, Korea, Republic of, 158 710
[Recruiting]
Seoul, Korea, Republic of
[Recruiting]
Suwon Gyeonggi do, Korea, Republic of, 442 723
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links: Description: Related Info
Description: Related Info
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services