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

NCT02274285 | Completed Phase 3

• 2 other identifiers: J2I02 (EFC13640)U1111-1143-9112
• Study Type: interventional
• Target: 424
• Locations: 1 country
• Sites: 12

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)

Conditions

Tetanus; Diphtheria; Pertussis; Poliomyelitis; Bacterial Meningitis

Keywords

Tetanus; Diphtheria; Pertussis; Poliomyelitis; Bacterial meningitis; DTaP-IPV/Hib Combination vaccine

Outcome Measures

Primary Outcomes (1)

• 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)

  21 Days post-dose 3

Secondary Outcomes (3)

• Percentage of participants with Seroprotection to vaccine antigens following vaccination

  Day 0 (pre-vaccination ) and 21 Days post-dose 3

• Geometric Mean Titer (GMT) of antibodies to vaccine antigens following vaccination

  21 Days post-dose 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.

  Day 0 (post-vaccination) up to 21 days post each vaccination

Study Arms (3)

Group A (SP0204)

EXPERIMENTAL

Participants will receive DTaP-IPV/Hib vaccine administered subcutaneously

Biological: DTaP-IPV/Hib Combined vaccine

Group B (control)

ACTIVE COMPARATOR

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

Biological: DTaP-IPV vaccine and Hib vaccine

Group C

EXPERIMENTAL

Participants will receive DTaP-IPV/Hib vaccine administered intramuscularly

Biological: DTaP-IPV/Hib Combined vaccine

Interventions

DTaP-IPV/Hib Combined vaccine BIOLOGICAL

0.5 mL, Subcutaneously. 3 times, each given 3 to 8 weeks apart

Also known as: SP0204

Group A (SP0204)

DTaP-IPV vaccine and Hib vaccine BIOLOGICAL

0.5 mL each, Subcutaneously, 3 times, each given 3 to 8 weeks apart

Also known as: DD 687; DF 098

Group B (control)

Eligibility Criteria

• Age: 2 Months - 68 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (12)

Unknown Facility

Aichi, Japan

Location

Unknown Facility

Chiba, Japan

Location

Unknown Facility

Fukui, Japan

Location

Unknown Facility

Fukuoka, Japan

Location

Unknown Facility

Gunma, Japan

Location

Unknown Facility

Hokkaido, Japan

Location

Unknown Facility

Miyagi, Japan

Location

Unknown Facility

Nagano, Japan

Location

Unknown Facility

Osaka, Japan

Location

Unknown Facility

Shizuoka, Japan

Location

Unknown Facility

Tokyo, Japan

Location

Unknown Facility

Yamanashi, Japan

Location

Related Publications (1)

• 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.

  PMID: 32307307 RESULT

MeSH Terms

Conditions

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

Interventions

HibTITER protein, Haemophilus influenzae

Condition Hierarchy (Ancestors)

Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Corynebacterium Infections; Actinomycetales Infections; Bordetella Infections; Gram-Negative Bacterial Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Myelitis; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases; Central Nervous System Bacterial Infections; Meningitis

Study Officials

• Medical Director

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2014
• First Posted: October 24, 2014
• Study Start: October 1, 2014
• Primary Completion: May 28, 2016
• Study Completion: May 28, 2016
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

JP (12)