DTaP-IPV-Hep B-PRP~T Combined Vaccine Versus DTaP-IPV//PRP~T Combined Vaccine + Hep B Vaccine in Hep B Primed Infants

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02094833
• Date of registration: 20/03/2014
• Prospective Registration: No
• Primary sponsor: Sanofi Pasteur, a Sanofi Company
• Public title: DTaP-IPV-Hep B-PRP~T Combined Vaccine Versus DTaP-IPV//PRP~T Combined Vaccine + Hep B Vaccine in Hep B Primed Infants
• Scientific title: Immunogenicity and Safety of Sanofi Pasteur's DTaP-IPV-Hep B-PRP~T Combined Vaccine at 2, 4, and 6 Months of Age Versus Sanofi Pasteur's DTaP IPV//PRP~T Combined Vaccine at 2, 4, and 6 Months of Age + Hep B Vaccine at 1 and 6 Months of Age, in South Korean Infants Primed With Hep B at Birth
• Date of first enrolment: March 2014
• Target sample size: 310
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02094833
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Korea, Republic of

Contacts

• Name: Medical Director
• Affiliation: Sanofi Pasteur SA

Key inclusion & exclusion criteria

Inclusion Criteria:

- Aged 30 to 40 days on the day of the first study visit

- Born at full term of pregnancy (= 37 weeks) and with a birth weight = 2.5 kg

- Informed consent form has been signed and dated by the parent(s) or other legally
acceptable representative

- Participant and parent/legally acceptable representative are able to attend all
scheduled visits and to comply with all trial procedures

- Born to known hepatitis B surface antigen (HBsAg) seronegative mother (documented
laboratory result of HBsAg assay from the maternal blood sample is available)

- Have received one documented dose of Hep B vaccine at birth according to the national
recommendations.

Exclusion Criteria:

- Participation in the 4 weeks preceding the trial inclusion or planned participation
during the present trial period in another clinical trial investigating a vaccine,
drug, medical device, or medical procedure

- Receipt of any vaccine in the 4 weeks preceding any trial vaccination (except Bacille
Calmette Guerin (BCG) vaccine) or planned receipt of any vaccine in the 8 days
following any trial vaccination

- Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis
B (except the dose of Hep B vaccine given at birth) diseases or Haemophilus influenzae
type b infection with either the trial vaccine or another vaccine

- Past or current receipt of immune globulins, blood or blood-derived products or
planned administration during the trial

- Known or suspected congenital or acquired immunodeficiency; or receipt of
immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy,
since birth; or long-term systemic corticosteroid therapy (prednisone or equivalent
for more than 2 consecutive weeks since birth)

- Known personal or maternal history of Human Immunodeficiency Virus (HIV) or hepatitis
C seropositivity

- History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Haemophilus
influenzae type b infection, confirmed either clinically, serologically, or
microbiologically

- Known systemic hypersensitivity to any of the vaccine components, or history of a
life-threatening reaction to the vaccines used in the trial or to a vaccine containing
any of the same substances

- Known thrombocytopenia, as reported by the parent/legally acceptable representative

- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
contraindicating intramuscular vaccination

- In an emergency setting, or hospitalized involuntarily

- Chronic illness that, in the opinion of the investigator, is at a stage where it might
interfere with trial conduct or completion

- Moderate or severe acute illness/infection (according to investigator judgment) on the
day of vaccination or febrile illness (temperature = 38.0°C). A prospective
participant should not be included in the study until the condition has resolved or
the febrile event has subsided

- Identified as a natural or adopted child of the Investigator or employee with direct
involvement in the proposed study

- History of seizures.



Age minimum: 1 Month
Age maximum: 6 Months
Gender: All

Health Condition(s) or Problem(s) studied

Poliomyelitis

Diphtheria

Tetanus

Hepatitis B

Haemophilus Influenzae Type b Infection

Pertussis

Intervention(s)

Biological: DTaP-IPV//PRP~T and Hepatitis B vaccine

Biological: DTaP-IPV-Hep B-PRP~T combined vaccine

Primary Outcome(s)

Number of participants with anti-Tetanus antibody concentrations = 0.1 International unit (IU)/mL [Time Frame: 1 month post third vaccination]

Number of participants with anti-Diphtheria antibody concentrations = 0.01 International Units (IU)/mL [Time Frame: 1 month post third vaccination]

Number of participants with = 4 fold increase in anti-PT and anti-FHA antibody concentrations (EU/mL) from 1 month pre-dose 1 to 1 month post-dose 3 [Time Frame: I month post dose 3]

Secondary Outcome(s)

Number of participants with anti Diphtheria antibody concentrations = 0.1 IU/mL International Units (IU)/mL [Time Frame: 1 month post third vaccination]

Number of participants with anti-Diphtheria antibody concentrations = 0.01 IU/mL and = 0.1 IU/mL International Units (IU)/mL [Time Frame: Day 0 Pre-vaccination]

Number of participants reporting solicited injection site and solicited systemic reactions, unsolicited adverse events, and serious adverse events following vaccination with either DTaP-IPV-Hep B-PRP~T combined vaccine or Pentaxim™ and Euvax B® vaccine [Time Frame: Day 0 and up to Day 180 post-vaccination]

Number of participants with response to vaccine Pertussis toxoid (PT) and Filamentous Haemagglutinin (FHA) antigens [Time Frame: 1 month post third vaccination]

Number of participants with anti-Hepatitis B antibody concentrations = 10 mIU/mL international unit (IU)/mL [Time Frame: Day 0 Pre-vaccination]

Secondary ID(s)

A3L31

U1111-1127-6896

Source(s) of Monetary Support

Please refer to primary and secondary sponsors