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

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ClinicalTrials.gov Identifier: NCT02274285
Recruitment Status : Completed
First Posted : October 24, 2014
Last Update Posted : June 29, 2017
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

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)

Condition or disease Intervention/treatment Phase
Tetanus Diphtheria Pertussis Poliomyelitis Bacterial Meningitis Biological: DTaP-IPV/Hib Combined vaccine Biological: DTaP-IPV vaccine and Hib vaccine Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 424 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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
Actual Study Start Date : October 2014
Actual Primary Completion Date : May 28, 2016
Actual Study Completion Date : May 28, 2016


Arm Intervention/treatment
Experimental: Group A (SP0204)
Participants will receive DTaP-IPV/Hib vaccine administered subcutaneously
Biological: DTaP-IPV/Hib Combined vaccine
0.5 mL, Subcutaneously. 3 times, each given 3 to 8 weeks apart
Other Name: SP0204

Active Comparator: Group B (control)
Participants will be given a co-administration of DTaP-IPV vaccine and Hib vaccine subcutaneously
Biological: DTaP-IPV vaccine and Hib vaccine
0.5 mL each, Subcutaneously, 3 times, each given 3 to 8 weeks apart
Other Name: DD 687; DF 098

Experimental: Group C
Participants will receive DTaP-IPV/Hib vaccine administered intramuscularly
Biological: DTaP-IPV/Hib Combined vaccine
0.5 mL, Intramuscularly. 3 times, each given 4 to 8 weeks apart
Other Name: SP0204




Primary Outcome Measures :
  1. Percentage of participants with anti-Diphtheria level ≥ 0.1 IU/mL post-dose 3 [ Time Frame: 21 Days 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 :
  1. Percentage of participants with Seroprotection to vaccine antigens following vaccination [ Time Frame: Day 0 (pre-vaccination ) and 21 Days post-dose 3 ]
    Seroprotection is defined as: percentage of participants with anti-Diphtheria and anti Tetanus antibody levels ≥0.01, ≥0.1 and ≥1.0 IU/mL

  2. Geometric Mean Titer (GMT) of antibodies to vaccine antigens following vaccination [ Time Frame: 21 Days 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)

  3. 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. [ Time Frame: Day 0 (post-vaccination) up to 21 days post each vaccination ]
    Solicited injection site reactions: Tenderness, Erythema, Swelling and Induration; Solicited Systemic Reactions: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost and Irritability.



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Ages Eligible for Study:   2 Months to 68 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02274285


Locations
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Japan
Aichi, Japan
Chiba, Japan
Fukui, Japan
Fukuoka, Japan
Gunma, Japan
Hokkaido, Japan
Miyagi, Japan
Nagano, Japan
Osaka, Japan
Shizuoka, Japan
Tokyo, Japan
Yamanashi, Japan
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Medical Director Sanofi K.K.

Additional Information:
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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT02274285     History of Changes
Other Study ID Numbers: J2I02 (EFC13640)
U1111-1143-9112 ( Other Identifier: WHO )
First Posted: October 24, 2014    Key Record Dates
Last Update Posted: June 29, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) and supporting clinical documents are available for request at www.clinicalstudydatarequest.com. While making information available the company continue to protect the privacy of the participants in clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: Clinicalstudydatarequest.com/Sanofi".
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Tetanus
Diphtheria
Pertussis
Poliomyelitis
Bacterial meningitis
DTaP-IPV/Hib Combination vaccine
Additional relevant MeSH terms:
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Whooping Cough
Tetanus
Diphtheria
Meningitis, Bacterial
Poliomyelitis
Meningitis
Central Nervous System Diseases
Nervous System Diseases
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Corynebacterium Infections
Actinomycetales Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Myelitis
Central Nervous System Infections
Spinal Cord Diseases
Neuromuscular Diseases
Central Nervous System Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs