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

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Tetanus; Diphtheria; Pertussis; Poliomyelitis; Bacterial Meningitis

Intervention: DTaP-IPV/Hib Combined vaccine (Biological); DTaP-IPV vaccine and Hib vaccine (Biological)

Phase: Phase 3

Status: Recruiting

Sponsored by: Sanofi Pasteur, a Sanofi Company

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Sanofi K.K.

Overall contact:
Public Registry Sanofi Pasteur, Email: RegistryContactUs@sanofipasteur.com


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).

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Primary outcome: Percentage of participants with anti-Diphtheria level ≥ 0.1 IU/mL post-dose 3

Secondary outcome:

Percentage of participants with Seroprotection to vaccine antigens following vaccination

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

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.

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.


Minimum age: 3 Months. Maximum age: 68 Months. Gender(s): Both.


Inclusion Criteria:

- Aged 3 months to 68 months inclusive (recommended 3 to 8 months) on the day of


- 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


- 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.

Locations and Contacts

Public Registry Sanofi Pasteur, Email: RegistryContactUs@sanofipasteur.com

Aichi, Japan; Recruiting

Chiba, Japan; Recruiting

Fukui, Japan; Recruiting

Fukuoka, Japan; Recruiting

Gunma, Japan; Recruiting

Hokkaido, Japan; Recruiting

Miyagi, Japan; Recruiting

Nagano, Japan; Recruiting

Osaka, Japan; Recruiting

Shizuoka, Japan; Recruiting

Tokyo, Japan; Recruiting

Yamanashi, Japan; Recruiting

Additional Information

Starting date: October 2014
Last updated: April 30, 2015

Page last updated: August 23, 2015

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