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

• Register: ClinicalTrials.gov
• Last refreshed on: 2 May 2022
• Main ID: NCT02274285
• Date of registration: 22/10/2014
• Prospective Registration: No
• Primary sponsor: Sanofi Pasteur, a Sanofi Company
• Public title: DTaP-IPV/Hib Vaccine Primary & Booster Vaccinations Versus Co-administration of DTaP-IPV and Hib Vaccine in Japanese Infants
• Scientific 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
• Date of first enrolment: October 2014
• Target sample size: 424
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02274285
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 3

Countries of recruitment

Japan

Contacts

• Name: Medical Director
• Affiliation: Sanofi K.K.

Key inclusion & exclusion 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.



Age minimum: 2 Months
Age maximum: 68 Months
Gender: All

Health Condition(s) or Problem(s) studied

Tetanus

Diphtheria

Bacterial Meningitis

Poliomyelitis

Pertussis

Intervention(s)

Biological: DTaP-IPV vaccine and Hib vaccine

Biological: DTaP-IPV/Hib Combined vaccine

Primary Outcome(s)

Percentage of participants with anti-Diphtheria level = 0.1 IU/mL post-dose 3 [Time Frame: 21 Days post-dose 3]

Secondary Outcome(s)

Percentage of participants with Seroprotection to vaccine antigens following vaccination [Time Frame: Day 0 (pre-vaccination ) and 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. [Time Frame: Day 0 (post-vaccination) up to 21 days post each vaccination]

Geometric Mean Titer (GMT) of antibodies to vaccine antigens following vaccination [Time Frame: 21 Days post-dose 3]

Secondary ID(s)

J2I02 (EFC13640)

U1111-1143-9112

Source(s) of Monetary Support

Please refer to primary and secondary sponsors