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

• Sponsor: Sanofi Pasteur, a Sanofi Company
• Information provided by (Responsible Party): Sanofi ( Sanofi Pasteur, a Sanofi Company )

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)

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Locations

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

• Study Director: Medical Director; Sanofi K.K.

More Information

Additional Information:

Related Info  Related Info 

• 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
• 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:

Meningitis; Whooping Cough; Tetanus; Diphtheria; Poliomyelitis; Meningitis, Bacterial; 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