Clinical trial NCT01948193: Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine in Indian Infants Previously Given a Dose of Hepatitis B Vaccine at Birth
Official title: Immunogenicity and Safety of Sanofi Pasteur's DTaP-IPV-Hep B-PRP-T Combined Vaccine Given at 6, 10 and 14 Weeks of Age in Infants From India Who Previously Received a Dose of Hepatitis B Vaccine at Birth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diphtheria
Tetanus
Whooping Cough
Hepatitis B
Poliomyelitis
Invasive Hib Infections
Keywords: Diphtheria
Tetanus
Whooping Cough
Hepatitis B
Poliomyelitis
DTaP IPV-Hep B-PRP~T combined vaccine (Hexaxim™)
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2013-09-23
Enrollment: 177
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to describe the immunogenicity and safety of a novel DTaP- IPV- Hep B-PRT\~T fully liquid combined hexavalent vaccine (Hexaxim™) administered at 6, 10 and 14 weeks of age in infants born to mothers documented to be serum anti-hepatitis B surface antigen (HBsAg) serology negative in India.

Primary Objective:

* To evaluate the immunogenicity of the study vaccine in terms of seroprotection \[diphtheria toxoid, tetanus toxoid, poliovirus types 1, 2 and 3, Haemophilus influenzae type b (Hib) polysaccharide (PRP), hepatitis B (Hep B)\] and vaccine response for pertussis antigens \[pertussis toxoid (PT) and filamentous haemagglutinin (FHA)\] one month after the third dose.

Secondary Objectives:

* To further describe the immunogenicity of the study vaccine, before the first dose and one month after the third dose.
* To describe the safety after each and any doses of the study vaccine.

Detailed description: All participants will receive a total 4 doses of Hep B, i.e. one dose of Hep B monovalent vaccine given at birth followed by 3 doses of Sanofi Pasteur's hexavalent vaccine given at 6, 10 and 14 weeks of age in the context of the study. Participants and parents will attend four clinic visits; the expected participation in the study is approximately 3 months.

Eligibility criteria: Inclusion Criteria:

* Aged between 42-56 days (6 to 8 weeks) on the day of inclusion
* Born at full term of pregnancy (≥37 weeks) and with a birth weight ≥2.5 kg
* Informed consent form signed by the parent(s) or any other legally acceptable representative
* Subject 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 maternal blood sample performed during last trimester of pregnancy available)
* Have received one documented dose of Hep B vaccine and oral poliovirus vaccine (OPV) from birth as per national recommendations.

Exclusion Criteria:

* 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
* Receipt of any vaccine in the 4 weeks preceding the first trial vaccination (except Bacillus Calmette-Guerin \[BCG\] vaccine) or planned receipt of any other vaccine within the period from 8 days before to 8 days after each subsequent trial vaccination
* 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
* 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)
* History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Hib infections (confirmed either clinically, serologically or microbiologically)
* Known personal or maternal history of Human Immunodeficiency Virus (HIV) or hepatitis C seropositivity
* 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
* 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 (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)
* Identified as a natural or adopted child of the Investigator, relatives or employee with direct involvement in the proposed study
* History of seizures.

Primary outcomes:
measure: Percentage of Participants With Seroprotection After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth
timeFrame: Pre-dose 1 to one month post-dose 3
measure: Percentage of Participants With Vaccine Response After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth
timeFrame: Pre-dose 1 to one month post-dose 3
Secondary outcomes:
measure: Percentage of Participants With Seroprotection Before and After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth
timeFrame: Pre-dose 1 to one month post-dose 3
measure: Geometric Mean Titers of Antibodies Against Vaccine Antigens After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine After a Documented Dose of an Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth
timeFrame: Pre-dose 1 to one month post-dose 3
measure: Geometric Mean Titer Ratios of Antibodies Against Vaccine Antigens After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine After a Documented Dose of Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth
timeFrame: Pre-dose 1 to one month post-dose 3
measure: Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
timeFrame: Within 7 days after each vaccine injection
Other outcomes:
Locations:
city: Ludhiana
country: India
state: Punjab
city: Pune
country: India
Study officials:
affiliation: Sanofi Pasteur SA
name: Medical Director
role: STUDY_DIRECTOR
References: