Clinical trial NCT02274285: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tetanus
Diphtheria
Pertussis
Poliomyelitis
Bacterial Meningitis
Keywords: Tetanus
Diphtheria
Pertussis
Poliomyelitis
Bacterial meningitis
DTaP-IPV/Hib Combination vaccine
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2014-10-24
Enrollment: 424
Sex: ALL
Minimum age (years): 2
Maximum age (years): 68
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Percentage of participants with anti-Diphtheria level ≥ 0.1 IU/mL post-dose 3
timeFrame: 21 Days post-dose 3
Secondary outcomes:
measure: Percentage of participants with Seroprotection to vaccine antigens following vaccination
timeFrame: Day 0 (pre-vaccination ) and 21 Days post-dose 3
measure: Geometric Mean Titer (GMT) of antibodies to vaccine antigens following vaccination
timeFrame: 21 Days post-dose 3
measure: 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.
timeFrame: Day 0 (post-vaccination) up to 21 days post each vaccination
Other outcomes:
Locations:
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
Study officials:
affiliation: Sanofi
name: Medical Director
role: STUDY_DIRECTOR
References:
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.