Immunogenicity and Safety of Sanofi Pasteur's Combined Vaccine Given as a Three-Dose Primary Series at 2, 3,4 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
Study Details
Study Description
Brief Summary
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:
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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.
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To evaluate the immunogenicity of the study vaccine one month after the 3-dose primary series.
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To describe the persistence of all antibodies before receipt of the booster vaccination.
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To evaluate the immunogenicity of the study vaccine one month after the booster.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 3 |
Detailed Description
Participants will receive a total of 5 doses of Hep B: One dose of Hep B monovalent vaccine given at birth or within 1 week after birth followed by 3 doses of the Sanofi Pasteur's hexavalent vaccine given as primary series at 2, 3, and 4 months of age and then a booster dose at 16 to 17 months of age, to comply with Vietnamese vaccination recommendations.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: DTaP-IPV-HB-PRP~T Vaccine All participants will receive 3 doses of 0.5 mL DTaP-IPV-HB-PRP~T combined vaccine, intramuscularly, at 2, 3 and 4 months of age (primary series), followed by a booster dose approximately 12 months after the completion of the primary series (at 16 to 17 months of age). |
Biological: Hexaxim®
DTaP-IPV-Hep B-PRP-T combined vaccine, 0.5 mL, Intramuscular
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants Reporting Solicited Injection Site Reactions or Solicited Systemic Reactions [Within 7 days after vaccination]
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
Secondary Outcome Measures
- Number of Subjects With Seroprotection/Seroconversion/Vaccine Response After Infant Series in Cohort 1 [Day 90 (1 month after third dose)]
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
- Number of Subjects With Seroprotection/Seroconversion/Vaccine and Booster Response Before and After Booster Vaccination in Cohort 1 [Day 425 (pre-booster) and Day 455 (1 month after booster dose)]
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
- Geometric Mean Titers or Geometric Mean Concentrations of DTaP-IPV-HB-PRP~T Antibodies Before and After Infant Series in Cohort [Day 90 (1 month after third dose)]
Geometric mean of concentrations of antibodies against PT, FHA, diphtheria, tetanus, PRP, poliovirus 1, 2 and 3, and Hep B
- Geometric Mean Titers or Geometric Mean Concentrations of DTaP-IPV-HB-PRP~T Antibodies Before and After Booster Vaccination in Cohort 1 [Day 425 (pre-booster) and Day 455 (1 month after booster dose)]
Geometric mean of concentrations of antibodies against PT, FHA, diphtheria, tetanus, PRP, poliovirus 1, 2 and 3, and Hep B
- Percentage of Subjects With Seroprotection/Seroconversion Rates after Infant Series in Cohort 1 and Group 3 of A3L15 (NCT01105559) [Day 90 (1 month after third dose)]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Aged 61 to 91 days on the day of the first study visit
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Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥2.5 kg
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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)
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Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
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Have received one dose of Hep B vaccine at birth or within 1 week after birth (documented according to the national recommendations).
Exclusion Criteria:
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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
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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)
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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)
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Past or current receipt of immune globulins, blood or blood-derived products or planned administration during the trial
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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)
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History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Haemophilus influenzae type b infections (confirmed either clinically, serologically or microbiologically)
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Known personal or maternal history of Human Immunodeficiency Virus (HIV), or hepatitis C seropositivity
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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
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Known thrombocytopenia, as reported by the parent/legally acceptable representative
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Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
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History of seizures
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In an emergency setting, or hospitalized involuntarily
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Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
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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
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Identified as a natural or adopted child of the Investigator, relatives or employee with direct involvement in the proposed study.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Preventive Medicine Centre of Thai Binh Province | Thai Binh | Vietnam |
Sponsors and Collaborators
- Sanofi Pasteur, a Sanofi Company
Investigators
- Study Director: Medical Director, Sanofi Pasteur SA
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- A3L35
- U1111-1143-8177
- NCT02821195