Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine in Indian Infants Previously Given a Dose of Hepatitis B Vaccine at Birth
- Conditions
- Prevention of infections caused by Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, poliovirus type 1, 2 and 3, prevention against invasive infections caused by Haemophilus influenzae type b and infection caused by hepatitis B virusTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2016-002089-29-Outside-EU/EEA
- Lead Sponsor
- Sanofi Pasteur SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 177
An individual must fulfill all of the following criteria in order to be eligible for trial enrollment:
1) Aged between 42-56 days (6 to 8 weeks) on the day of inclusion
2) Born at full term of pregnancy (=37 weeks) and with a birth weight =2.5 kg
3) Informed consent form signed by the parent(s) or any other legally acceptable representative
4) Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
5) Born to known HBsAg seronegative mother (documented laboratory result of HBsAg assay from maternal blood sample performed during
last trimester of pregnancy available)
6) Have received one documented dose of Hep B vaccine and OPV from birth as per national recommendations
Are the trial subjects under 18? yes
Number of subjects for this age range: 177
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
An individual fulfilling any of the following criteria is to be excluded from trial enrollment:
1) Participation in another clinical trial 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
2) Receipt of any vaccine in the 4 weeks preceding the first trial vaccination (except BCG vaccine) or planned receipt of any other
vaccine within the period from 8 days before to 8 days after each subsequent trial vaccination
3) Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis (expect the birth dose of OPV as per national
recommendations) and hepatitis B (except the birth dose of Hep B vaccine) diseases or Hib infection with the trial vaccine or another
vaccine
4) Past or current receipt of immune globulins, blood or blood-derived products or planned administration during the trial
5) 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)
6) History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Hib infections (confirmed either clinically, serologically or
microbiologically)
7) Known personal or maternal history of HIV or hepatitis C seropositivity
8) Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine
containing the same substances
9) Known thrombocytopenia, as reported by the parent/legally acceptable representative
10) Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
11) In an emergency setting, or hospitalized involuntarily
12) Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
13) Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (axillary
temperature =38°C) on the day of inclusion (a prospective subject should not be included in the study until the condition has resolved or
the febrile event has subsided)
14) Identified as a natural or adopted child of the Investigator, relatives or employee with direct involvement in the proposed study
15) History of seizures
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method