Hepatitis B Clinical Trial
Official title:
Immunogenicity and Safety of GSK Biologicals' Combined Diphtheria-tetanus-acellular Pertussis-inactivated Poliovirus and Haemophilus Influenzae Type b (DTPa-IPV/Hib) Conjugate Vaccine
Verified date | September 2019 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the immune response, safety and reactogenicity after receiving combined DTPa-IPV/Hib vaccine when administered as a three-dose primary vaccination course at 3, 4.5 and 6 months of age and as a booster dose at 18 months of age in Russian healthy children according to the Russian immunisation schedule
Status | Completed |
Enrollment | 235 |
Est. completion date | November 13, 2018 |
Est. primary completion date | October 24, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 3 Months to 19 Months |
Eligibility |
Inclusion Criteria: - Subjects' parent(s)/Legally Acceptable Representatives [LARs] who, in the opinion of the investigator, can and will comply with the requirements of the protocol. - A male or female child between 3 and 4 months of age at the time of the first vaccination. - Written informed consent obtained from the parents/LARs of the subject prior to performing any study specific procedure. - Healthy subjects as established by medical history and clinical examination before entering into the study. - Born full-term. Exclusion Criteria: - Child in care - Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the first dose of study vaccine, or planned use during the study period. - Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe. - Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting since birth. For corticosteroids, this will mean prednisone = 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed. - Administration of long-acting immune-modifying drugs at any time during the study period - Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of vaccine administration, with the exception of hepatitis B and other vaccines given as part of the national immunisation schedule and as part of routine vaccination practice, that are allowed at any time during the study period. Seasonal or pandemic influenza vaccine can be given at any time during the study, and according to the Summary of Product Characteristics and national recommendations. - Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product - Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis and Hib diseases. - History of diphtheria, tetanus, pertussis, poliomyelitis and Hib diseases. - Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. - Family history of congenital or hereditary immunodeficiency. - History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine. - Major congenital defects. - Serious chronic illness. - History of any neurological disorders or seizures. - Acute disease and/or fever at the time of enrolment. - Fever is defined as temperature =37.5°C for oral, axillary or tympanic route, or =38.0°C for rectal route. - Subjects with a minor illness without fever may be enrolled at the discretion of the investigator. - Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | GSK Investigational Site | Barnaul | |
Russian Federation | GSK Investigational Site | Ekaterinburg | |
Russian Federation | GSK Investigational Site | Murmansk | |
Russian Federation | GSK Investigational Site | St.Petersburg | |
Russian Federation | GSK Investigational Site | Tomsk |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T), Post Primary Vaccination | A seroprotected subject is a subject whose anti-D and anti-T antibody concentration was greater than or equal to (=) 0.1 International Units per milliliter (IU/mL). | At Month 4 (i.e. one month after 3rd dose of primary vaccination) | |
Primary | Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3, Post Primary Vaccination | A seroprotected subject is a subject whose anti-poliovirus types 1, 2 and 3 antibody titer was = 8 ED50. | At Month 4 (i.e. one month after 3rd dose of primary vaccination) | |
Primary | Number of Seroprotected Subjects for Anti-polyribosyl Ribitol Phosphate (Anti-PRP), Post Primary Vaccination | A seroprotected subject is a subject whose anti-PRP antibody concentration was = 0.15 micrograms per milliliter (µg/mL). | At Month 4 (i.e. one month after 3rd dose of primary vaccination) | |
Primary | Number of Seropositive Subjects for Anti-pertussis (Anti- PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN), Post Primary Vaccination | A seropositive subject is a subject whose antibody concentration was = 2.046 IU/mL for anti-FHA, = 2.187 IU/mL for anti-PRN and = 2.693 IU/mL for anti-PT. | At Month 4 (i.e. one month after 3rd dose of primary vaccination) | |
Secondary | Number of Seroprotected Subjects for Anti-D and Anti-T, Post Booster Vaccination | A seroprotected subject is a subject whose anti-D and anti-T antibody concentration was = 0.1 IU/mL. | At Month 16 (i.e. one month after booster vaccination) | |
Secondary | Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3, Post Booster Vaccination | A seroprotected subject is a subject whose anti-poliovirus types 1, 2 and 3 antibody titer was = 8 ED50. | At Month 16 (i.e. one month after booster vaccination) | |
Secondary | Number of Seroprotected Subjects for Anti-PRP, Post Booster Vaccination | A seroprotected subject is a subject whose anti-PRP antibody concentration was = 0.15 µg/mL. | At Month 16 (i.e. one month after booster vaccination) | |
Secondary | Number of Seropositive Subjects for Anti- PT, Anti-FHA and Anti-PRN, Post Booster Vaccination | A seropositive subject is a subject whose antibody concentration was = 2.046 IU/mL for anti-FHA, = 2.187 IU/mL for anti-PRN and = 2.693 IU/mL for anti-PT. | At Month 16 (i.e. one month after booster vaccination) | |
Secondary | Antibody Concentrations for Anti-D and Anti-T, Post Primary Vaccination | The antibody concentrations for anti-D and anti-T were presented as geometric mean concentrations (GMCs) and expressed as IU/mL. | At Month 4 (i.e. one month after 3rd dose of primary vaccination) | |
Secondary | Antibody Concentrations for Anti-D and Anti-T, Post Booster Vaccination | The antibody concentrations for anti-D and anti-T were presented as geometric mean concentrations (GMCs) and expressed as IU/mL. | At Month 16 (i.e. one month after booster vaccination) | |
Secondary | Antibody Titers for Anti-polio Types 1, 2 and 3, Post Primary Vaccination | The antibody titers for anti-polio types 1, 2 and 3 were presented as geometric mean titres (GMTs). | At Month 4 (i.e. one month after 3rd dose of primary vaccination) | |
Secondary | Antibody Titers for Anti-polio Types 1, 2 and 3, Post Booster Vaccination | The antibody titers for anti-polio types 1, 2 and 3 were presented as geometric mean titres (GMTs). | At Month 16 (i.e. one month after booster vaccination) | |
Secondary | Antibody Concentration for Anti-PRP, Post Primary Vaccination | The antibody concentrations for anti-PRP were presented as geometric mean concentrations (GMCs) and expressed as µg/mL. | At Month 4 (i.e. one month after 3rd dose of primary vaccination) | |
Secondary | Antibody Concentration for Anti-PRP, Post Booster Vaccination | The antibody concentrations for anti-PRP were presented as geometric mean concentrations (GMCs) and expressed as µg/mL. | At Month 16 (i.e. one month after booster vaccination) | |
Secondary | Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN, Post Primary Vaccination | The antibody concentrations for anti-PT, anti-FHA and anti-PRN were presented as GMCs and expressed as IU/mL. | At Month 4 (i.e. one month after 3rd dose of primary vaccination) | |
Secondary | Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN, Post Booster Vaccination | The antibody concentrations for anti-PT, anti-FHA and anti-PRN were presented as GMCs and expressed as IU/mL. | At Month 16 (i.e. one month after booster vaccination) | |
Secondary | Number of Subjects With Any Solicited Local Adverse Events (AEs) Following Each Dose of Primary Vaccination | The solicited local AEs assessed were pain, redness and swelling at injection site. Any = Occurrence of the AE regardless of the intensity grade. | During the 4-day (Days 0-3) follow-up period after each primary vaccination dose (i.e. at Day 0, at Month 1.5 and at Month 3) | |
Secondary | Number of Subjects With Any Solicited Local AEs Following Booster Vaccination | The solicited local AEs assessed were pain, redness and swelling at injection site. Any = Occurrence of the AE regardless of the intensity grade. | During the 4-day (Days 0-3) follow-up period after booster vaccination dose (i.e. at Month 15) | |
Secondary | Number of Subjects With Any Solicited General AEs Following Each Dose of Primary Vaccination | The solicited general AEs assessed were drowsiness, irritability/fussiness, loss of appetite and fever. Any = Occurrence of the AE regardless of the intensity grade. Any fever = Fever (axillary) = 37.5°C. | During the 4-day (Days 0-3) follow-up period after each primary vaccination dose (i.e. at Day 0, at Month 1.5 and at Month 3) | |
Secondary | Number of Subjects With Any Solicited General AEs Following Booster Vaccination | The solicited general AEs assessed were drowsiness, irritability/fussiness, loss of appetite and fever. Any = Occurrence of the AE regardless of the intensity grade. Any fever = Fever (axillary) = 37.5°C. | During the 4-day (Days 0-3) follow-up period after booster vaccination dose (i.e. at Month 15) | |
Secondary | Number of Subjects With Unsolicited AEs Following Each Dose of Primary Vaccination | An unsolicited AE was defined as any AE reported in addition to those solicited during the clinical study and any solicited AE with onset outside the specified period of follow-up for solicited AEs. Any = Occurrence of the AE regardless of the intensity grade. | During the 31-day (Days 0-30) follow-up period after each primary vaccination dose (i.e. at Day 0, at Month 1.5 and at Month 3) | |
Secondary | Number of Subjects With Unsolicited AEs Following Booster Vaccination | An unsolicited AE was defined as any AE reported in addition to those solicited during the clinical study and any solicited AE with onset outside the specified period of follow-up for solicited AEs. Any = Occurrence of the AE regardless of the intensity grade. | During the 31-day (Days 0-30) follow-up period after booster vaccination dose (i.e. at Month 15) | |
Secondary | Number of Subjects With Serious Adverse Events (SAEs) | The SAEs assessed included any untoward medical occurrences that resulted in death, were life threatening, required hospitalisation or prolongation of existing hospitalisation or resulted in disability/incapacity. Any = Occurrence of the AE regardless of the intensity grade. | During the entire study period (i.e. from Day 0 until Month 16) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01182311 -
Duration of Long-term Immunity After Hepatitis B Virus Immunization
|
||
Completed |
NCT04971928 -
Phase 1 Study of GSK3228836 Pharmacokinetics in Participants With Hepatic Impairment
|
Phase 1 | |
Completed |
NCT03285620 -
A Study of AL-034 to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses in Healthy Participants
|
Phase 1 | |
Completed |
NCT01884415 -
Phase III, Study to Evaluate the Efficacy of Two Different HBV Vaccination Schemes in Patients With Hepatic Cirrhosis
|
Phase 3 | |
Recruiting |
NCT05404919 -
Utilization of Hepatitis B Virus NAT+ Donors for Hepatitis B Vaccinated Lung Transplant Candidates
|
Phase 2 | |
Completed |
NCT02153320 -
Study to Evaluate the Persistence of the Cellular and Humoral Immune Response Following Vaccinations With GlaxoSmithKline (GSK) Biologicals' Candidate Vaccines Containing HBsAg and Different Adjuvants in Healthy Adult Volunteers
|
Phase 1 | |
Completed |
NCT00352963 -
Immunogenicity & Safety Study of Combined/Separate Vaccine(s) Against Common Diseases in Infants (2,4,6 Months of Age).
|
Phase 3 | |
Completed |
NCT03567382 -
Arresting Vertical Transmission of Hepatitis B Virus
|
Phase 4 | |
Not yet recruiting |
NCT04056728 -
A Phase IV Study to Assess the Safety of EupentaTM Inj
|
Phase 4 | |
Not yet recruiting |
NCT03604016 -
Study to Assess Efficacy of Besifovir and L-carnitine in Chronic Hepatitis B Patients With Nonalcoholic Fatty Liver
|
Phase 4 | |
Completed |
NCT00753649 -
Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants
|
Phase 4 | |
Recruiting |
NCT03027258 -
Point-of-Delivery Prenatal Test Results Through mHealth to Improve Birth Outcome
|
N/A | |
Completed |
NCT02540538 -
Safety and Immunogenicity of HBAI20 Hepatitis B Vaccine in Naive Adults and Non-responders
|
Phase 1 | |
Terminated |
NCT02604199 -
A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Negative, Chronic Hepatitis B Virus (HBV) Infection
|
Phase 2 | |
Completed |
NCT02421666 -
A Comparative Trial of Improving Care for Underserved Asian Americans Infected With HBV
|
N/A | |
Completed |
NCT02169674 -
Hepatitis B Booster Study in Adolescence
|
Phase 4 | |
Completed |
NCT01917357 -
A Comparison of the Immunogenicity and Safety of Quinvaxem in Mono-dose Vials and Uniject
|
Phase 3 | |
Completed |
NCT01368497 -
Entecavir/Pegylated Interferon in Immune Tolerant Children With Chronic Hepatitis B Virus (HBV) Infection
|
Phase 3 | |
Completed |
NCT01732354 -
Study for Consolidation Period of Chronic Hepatitis B
|
||
Recruiting |
NCT01462981 -
Cohort of Hepatitis B Research of Amsterdam
|
N/A |