search
Back to results

DTaP-IPV/Hib Vaccine Primary & Booster Vaccinations Versus Co-administration of DTaP-IPV and Hib Vaccine in Japanese Infants

Primary Purpose

Tetanus, Diphtheria, Pertussis

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
DTaP-IPV/Hib Combined vaccine
DTaP-IPV vaccine and Hib vaccine
DTaP-IPV/Hib Combined vaccine
Sponsored by
Sanofi Pasteur, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tetanus focused on measuring Tetanus, Diphtheria, Pertussis, Poliomyelitis, Bacterial meningitis, DTaP-IPV/Hib Combination vaccine

Eligibility Criteria

2 Months - 68 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Aged 2 months to 68 months inclusive (recommended 3 to 8 months for Groups A and B; 2 months for Group C) on the day of inclusion
  • Informed consent form signed by the parent(s) or other legal representative
  • Able to attend all scheduled visits and to comply with all trial procedures.

Exclusion Criteria:

  • Fever ≥ 37.5°C (axillary temperature) on the day of inclusion
  • Any serious disease whether acute or chronic
  • Past or current medical history of Guillain-Barre syndrome, acute thrombocytopenic purpura or encephalopathy
  • History of diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b infections
  • History of a life threatening reaction to a vaccine containing the same substances of the study vaccine
  • History of anaphylaxis to any of the study vaccine components
  • Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis or Haemophilus influenzae type b infections with a trial vaccine or another vaccine
  • Congenital or current acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
  • Participation in another clinical trial preceding the trial inclusion
  • Planned participation in another clinical trial during the present trial period
  • Blood or blood-derived products received in the past or current or planned administration during the trial (including immunoglobulins)
  • Any vaccination with live vaccines within the past 27 days preceding the first trial vaccination
  • Any vaccination with inactivated vaccines within the past 6 days preceding the first trial vaccination
  • Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or HIV infection
  • Subject ineligible according to the Investigator's clinical judgment
  • Identified as employee of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family member (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Group A (SP0204)

Group B (control)

Group C

Arm Description

Participants will receive DTaP-IPV/Hib vaccine administered subcutaneously

Participants will be given a co-administration of DTaP-IPV vaccine and Hib vaccine subcutaneously

Participants will receive DTaP-IPV/Hib vaccine administered intramuscularly

Outcomes

Primary Outcome Measures

Percentage of participants with anti-Diphtheria level ≥ 0.1 IU/mL post-dose 3
Anti-Diphtheria antibody titers will be assayed by neutralization test on Vero cells culture in comparison to the WHO equine antitoxin standard (seroneutralization)

Secondary Outcome Measures

Percentage of participants with Seroprotection to vaccine antigens following vaccination
Seroprotection is defined as: percentage of participants with anti-Diphtheria and anti Tetanus antibody levels ≥0.01, ≥0.1 and ≥1.0 IU/mL
Geometric Mean Titer (GMT) of antibodies to vaccine antigens following vaccination
Anti-Diphtheria antibody titers will be assayed by neutralization test on Vero cells culture in comparison to the WHO equine antitoxin standard (seroneutralization)
Information concerning the safety in terms of solicited injection site and systemic reactions, unsolicited adverse events, and serious adverse events post vaccination with DTaP IPV/Hib vaccine.
Solicited injection site reactions: Tenderness, Erythema, Swelling and Induration; Solicited Systemic Reactions: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost and Irritability.

Full Information

First Posted
October 22, 2014
Last Updated
April 21, 2022
Sponsor
Sanofi Pasteur, a Sanofi Company
search

1. Study Identification

Unique Protocol Identification Number
NCT02274285
Brief Title
DTaP-IPV/Hib Vaccine Primary & Booster Vaccinations Versus Co-administration of DTaP-IPV and Hib Vaccine in Japanese Infants
Official Title
Immunogenicity and Safety of the DTaP-IPV/Hib Vaccine SP0204) Given as Three-dose Primary and One-dose Booster Vaccinations Versus Co-administration of DTaP-IPV Vaccine (DD-687) and Hib Vaccine (DF-098) in Infants in Japan
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
October 2014 (Actual)
Primary Completion Date
May 28, 2016 (Actual)
Study Completion Date
May 28, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Primary objective: To demonstrate the non-inferiority in terms of seroprotection rates (Hib antigen (PRP), Diphtheria, Tetanus, and Pertussis antigens (PT and FHA), and polio types 1, 2 and 3 antigens) of investigational arm (Group A: DTaP-IPV/Hib) versus control arm (Group B: DTaP-IPV and Hib vaccines administered at separate sites), one month after the primary vaccination (all antigens). Secondary objectives: To describe immune responses against all vaccine antigens with no pre-specified hypothesis, and at all time points (pre-dose 1, post-dose 3, pre-dose 4 and post-dose 4) in the two study groups (Group A and Group B). To describe the safety after each dose of each vaccine in the two study groups (Group A and Group B). To describe immune responses against all vaccine antigens with no pre-specified hypothesis, and at all time points (pre-dose 1, post-dose 3, pre-dose 4 and post-dose 4 (Group C)
Detailed Description
Participants will be enrolled in two steps (Cohort 1 and Cohort 2). Step one will enroll Cohort 1 made of 40 participants randomized in two groups with a 1:1 ratio. After review of the local and systemic adverse events occurring during the 7 Days following the first dose administered in these subjects, 2nd vaccination of Cohort 1 participants will resume and enrollment of the participants of Cohort number 2 will start. Step two will enroll Cohort 2 made of subjects randomized in two groups with a 1:1 ratio. A sub-study Group C will be enrolled and will receive the vaccine by intramuscular route.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tetanus, Diphtheria, Pertussis, Poliomyelitis, Bacterial Meningitis
Keywords
Tetanus, Diphtheria, Pertussis, Poliomyelitis, Bacterial meningitis, DTaP-IPV/Hib Combination vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
424 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A (SP0204)
Arm Type
Experimental
Arm Description
Participants will receive DTaP-IPV/Hib vaccine administered subcutaneously
Arm Title
Group B (control)
Arm Type
Active Comparator
Arm Description
Participants will be given a co-administration of DTaP-IPV vaccine and Hib vaccine subcutaneously
Arm Title
Group C
Arm Type
Experimental
Arm Description
Participants will receive DTaP-IPV/Hib vaccine administered intramuscularly
Intervention Type
Biological
Intervention Name(s)
DTaP-IPV/Hib Combined vaccine
Other Intervention Name(s)
SP0204
Intervention Description
0.5 mL, Subcutaneously. 3 times, each given 3 to 8 weeks apart
Intervention Type
Biological
Intervention Name(s)
DTaP-IPV vaccine and Hib vaccine
Other Intervention Name(s)
DD 687; DF 098
Intervention Description
0.5 mL each, Subcutaneously, 3 times, each given 3 to 8 weeks apart
Intervention Type
Biological
Intervention Name(s)
DTaP-IPV/Hib Combined vaccine
Other Intervention Name(s)
SP0204
Intervention Description
0.5 mL, Intramuscularly. 3 times, each given 4 to 8 weeks apart
Primary Outcome Measure Information:
Title
Percentage of participants with anti-Diphtheria level ≥ 0.1 IU/mL post-dose 3
Description
Anti-Diphtheria antibody titers will be assayed by neutralization test on Vero cells culture in comparison to the WHO equine antitoxin standard (seroneutralization)
Time Frame
21 Days post-dose 3
Secondary Outcome Measure Information:
Title
Percentage of participants with Seroprotection to vaccine antigens following vaccination
Description
Seroprotection is defined as: percentage of participants with anti-Diphtheria and anti Tetanus antibody levels ≥0.01, ≥0.1 and ≥1.0 IU/mL
Time Frame
Day 0 (pre-vaccination ) and 21 Days post-dose 3
Title
Geometric Mean Titer (GMT) of antibodies to vaccine antigens following vaccination
Description
Anti-Diphtheria antibody titers will be assayed by neutralization test on Vero cells culture in comparison to the WHO equine antitoxin standard (seroneutralization)
Time Frame
21 Days post-dose 3
Title
Information concerning the safety in terms of solicited injection site and systemic reactions, unsolicited adverse events, and serious adverse events post vaccination with DTaP IPV/Hib vaccine.
Description
Solicited injection site reactions: Tenderness, Erythema, Swelling and Induration; Solicited Systemic Reactions: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost and Irritability.
Time Frame
Day 0 (post-vaccination) up to 21 days post each vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
68 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged 2 months to 68 months inclusive (recommended 3 to 8 months for Groups A and B; 2 months for Group C) on the day of inclusion Informed consent form signed by the parent(s) or other legal representative Able to attend all scheduled visits and to comply with all trial procedures. Exclusion Criteria: Fever ≥ 37.5°C (axillary temperature) on the day of inclusion Any serious disease whether acute or chronic Past or current medical history of Guillain-Barre syndrome, acute thrombocytopenic purpura or encephalopathy History of diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b infections History of a life threatening reaction to a vaccine containing the same substances of the study vaccine History of anaphylaxis to any of the study vaccine components Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis or Haemophilus influenzae type b infections with a trial vaccine or another vaccine Congenital or current acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy Participation in another clinical trial preceding the trial inclusion Planned participation in another clinical trial during the present trial period Blood or blood-derived products received in the past or current or planned administration during the trial (including immunoglobulins) Any vaccination with live vaccines within the past 27 days preceding the first trial vaccination Any vaccination with inactivated vaccines within the past 6 days preceding the first trial vaccination Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or HIV infection Subject ineligible according to the Investigator's clinical judgment Identified as employee of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family member (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Sanofi K.K.
Official's Role
Study Director
Facility Information:
City
Aichi
Country
Japan
City
Chiba
Country
Japan
City
Fukui
Country
Japan
City
Fukuoka
Country
Japan
City
Gunma
Country
Japan
City
Hokkaido
Country
Japan
City
Miyagi
Country
Japan
City
Nagano
Country
Japan
City
Osaka
Country
Japan
City
Shizuoka
Country
Japan
City
Tokyo
Country
Japan
City
Yamanashi
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Citations:
PubMed Identifier
32307307
Citation
Nakayama T, Vidor E, Tsuzuki D, Nishina S, Sasaki T, Ishii Y, Mizukami H, Tsuge H. Immunogenicity and safety of a DTaP-IPV/Hib pentavalent vaccine given as primary and booster vaccinations in healthy infants and toddlers in Japan. J Infect Chemother. 2020 Jul;26(7):651-659. doi: 10.1016/j.jiac.2019.11.012. Epub 2020 Apr 16.
Results Reference
result

Learn more about this trial

DTaP-IPV/Hib Vaccine Primary & Booster Vaccinations Versus Co-administration of DTaP-IPV and Hib Vaccine in Japanese Infants

We'll reach out to this number within 24 hrs