Hepatitis B Clinical Trial
Official title:
Immunogenicity and Safety of Sanofi Pasteur's DTaP-IPV-Hep B-PRP-T Combined Vaccine Given as a Three-Dose Primary Series at 2, 3, and 4 Months of Age and Followed by a Booster Dose Given at 16 to 17 Months of Age in Vietnamese Infants Who Previously Received a Dose of Hepatitis B Vaccine at Birth or Within 1 Week After Birth
Verified date | March 2022 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to describe the immunogenicity and safety of Sanofi Pasteur's DTaP-IPV-Hep B-PRP-T fully liquid combined hexavalent vaccine (Hexaxim®) administered at 2, 3, and 4 months of age and at 16 to 17 months of age in infants and toddlers who received a dose of Hep B vaccine at birth or within 1 week after birth. Primary Objective: - To describe the safety profile after each and all doses of Sanofi-Pasteur's DTaP-IPV-Hep B-PRP-T combined vaccine in Vietnamese infants and toddlers. Secondary Objective: - To demonstrate the non-inferiority of the immune response to all antigens induced by the study vaccine in Vietnamese infants one month after the third dose in a 3-dose primary series with the immune response to all antigens induced by the same study vaccine outside Vietnam. - To evaluate the immunogenicity of the study vaccine one month after the 3-dose primary series. - To describe the persistence of all antibodies before receipt of the booster vaccination. - To evaluate the immunogenicity of the study vaccine one month after the booster.
Status | Completed |
Enrollment | 354 |
Est. completion date | January 11, 2017 |
Est. primary completion date | January 11, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 61 Days to 91 Days |
Eligibility | Inclusion Criteria: - Aged 61 to 91 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 (and by an independent witness if required by local regulations) - Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures - Have received one dose of Hep B vaccine at birth or within 1 week after birth (documented according to the national recommendations). Exclusion Criteria: - Participation in the 4 weeks preceding the first trial vaccination 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 or planned receipt of any other vaccine within the period from 8 days before to 8 days after each subsequent trial vaccination except for Bacille Calmette Guerin (BCG) vaccination (any administration of oral poliovirus vaccine (OPV) in the context of oral poliovirus vaccine-national immunization days (NIDs) does not fall within the scope of this exclusion criterion) - Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B (except the dose of Hep B vaccine given at birth or within 1 week after birth) diseases or Haemophilus influenzae type b infection with either the trial vaccine or another vaccine (any administration of OPV in the context of OPV-NIDs does not fall within the scope of this exclusion criterion) - 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 Haemophilus influenzae type b 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 vaccine 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 - History of seizures - 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 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. |
Country | Name | City | State |
---|---|---|---|
Vietnam | Preventive Medicine Centre of Thai Binh Province | Thai Binh |
Lead Sponsor | Collaborator |
---|---|
Sanofi Pasteur, a Sanofi Company |
Vietnam,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants Reporting Solicited Injection Site Reactions or Solicited Systemic Reactions | Solicited injection site reactions: tenderness, erythema, and swelling (and extensive limb swelling for booster dose). Solicited systemic reactions: fever, vomiting, crying abnormal, drowsiness, appetite loss, and irritability | Within 7 days after vaccination | |
Secondary | Number of Subjects With Seroprotection/Seroconversion/Vaccine Response After Infant Series in Cohort 1 | Seroconversion:4-fold increase in anti-Pertussis(PT)& anti-Filamentous hemagglutinin(FHA) antibody(Ab) concentrations from pre-vaccination to one month after first dose.Vaccine response:anti-PT/anti-FHA Ab concentrations in Enzyme Linked Immunosorbent Assay(ELISA) units(EU)/mL>=4*Lower Limit of Quantitation(LLOQ) if pre-vaccination concentration <4*LLOQ/>=pre-vaccination concentration if prevaccination concentrations>=4*LLOQ. Seroprotection:anti-Diphtheria &anti-Tetanus>=0.01 International Units(IU)/mL&>=0.1 IU/mL;anti-PT &anti-FHA>=2 EU/mL &>=8 EU/mL;anti-Polyribosyl Ribitol Phosphate(PRP)>=0.15 microgram per milliliter(mcg/mL) &>=1.0mcg/mL;anti-Polio types 1,2,&3>=8(1/dilution),anti-Hepatitis B>=10 mili-international units per mililiter(mIU/mL)&>=100 mIU/mL | Day 90 (1 month after third dose) | |
Secondary | Number of Subjects With Seroprotection/Seroconversion/Vaccine and Booster Response Before and After Booster Vaccination in Cohort 1 | Seroconversion:4-fold increase in anti-PT & anti-FHA Ab concentrations from pre-booster vaccination to 1 month after booster dose.Vaccine response post-booster vaccination:post-booster Ab concentrations>=4*LLOQ if pre-dose 1 Ab concentrations<4*LLOQ/post-booster Ab concentrations>=predose 1 Ab concentrations if pre-dose 1>=4*LLOQ. Booster response:>=4 fold Ab concentrations increase from pre-dose 4 to one-month post-dose 4 if one-month post-dose 3<4*LLOQ/>=2 fold Ab concentrations increase from pre-dose 4 to one-month post-dose 4 if pre-dose 4>=4*LLOQ.Seroprotection:anti-Diphtheria
& anti-Tetanus>=0.01 IU/mL &>=0.1 IU/mL &>=1.0 IU/mL;anti-PRP >=0.15 mcg/mL &>=1.0 mcg/mL;anti-Polio types 1, 2, & 3>=8 (1/dilution),anti-Hepatitis B>=10 mIU/mL &>=100 mIU/mL |
Day 425 (pre-booster) and Day 455 (1 month after booster dose) | |
Secondary | Geometric Mean Titers or Geometric Mean Concentrations of DTaP-IPV-HB-PRP~T Antibodies Before and After Infant Series in Cohort | Geometric mean of concentrations of antibodies against PT, FHA, diphtheria, tetanus, PRP, poliovirus 1, 2 and 3, and Hep B | Day 90 (1 month after third dose) | |
Secondary | Geometric Mean Titers or Geometric Mean Concentrations of DTaP-IPV-HB-PRP~T Antibodies Before and After Booster Vaccination in Cohort 1 | Geometric mean of concentrations of antibodies against PT, FHA, diphtheria, tetanus, PRP, poliovirus 1, 2 and 3, and Hep B | Day 425 (pre-booster) and Day 455 (1 month after booster dose) | |
Secondary | Percentage of Subjects With Seroprotection/Seroconversion Rates after Infant Series in Cohort 1 and Group 3 of A3L15 (NCT01105559) | Seroconversion defined as 4-fold increase in anti-PT & anti-FHA Ab concentrations from pre-vaccination to one month after first dose. Seroprotection defined as following: anti-Diphtheria & anti-Tetanus >=0.01 IU/mL; anti-PT & anti-FHA >=4EU/mL; anti-PRP >=0.15 mcg/mL; anti-Polio types 1, 2, & 3 >=8 (1/dilution), anti-Hepatitis B >=10 mIU/mL. Results observed in Group 3 of Study A3L15 (NCT00362336), a study conducted in South Africa where participants had been given DTaP-IPV-HB-PRP~T at 6, 10, and 14 weeks of age following Hep B vaccination at birth, were used as the non-inferiority reference value | Day 90 (1 month after third dose) |
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