Back to resultsDTaP-IPV-HB-PRP-T Combined Vaccine as a Primary Series and a Second Year of Life Booster in HIV-Exposed Infected and Uninfected Infants
Primary Purpose
Diphtheria, Tetanus, Pertussis
Status
Completed
Phase
Phase 3
Locations
South Africa
Study Type
Interventional
Intervention
Hexaxim®: DTaP-IPV-HB-PRP-T Combined Vaccine
Hexaxim®: DTaP-IPV-HB-PRP-T Combined Vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Diphtheria focused on measuring Diphtheria, Tetanus, Pertussis, Hepatitis B, DTaP IPV HB PRP-T Combined Vaccine, Human Immunodeficiency Virus
Eligibility Criteria
Inclusion Criteria:
(Screening Criteria for the participants mother)
- At least 18 years of age at the time of the Screening blood sample draw
- Self-reported or maternity-reported HIV infection in the mother
Inclusion Criteria:
- Born to an adult mother and aged 35 to 56 days (between 5 and 8 weeks of age) on the day of inclusion
- Group A participants must be HIV infected, as documented through the results of a polymerase chain reaction (PCR) test, and following an anti-retroviral therapy according to the national recommendations; and Group B participants must be HIV exposed uninfected infants, as documented through the results of a PCR test.
- Born with a birth weight ≥ 2.0 kg
- Informed consent form signed by the parent(s)/legal guardian(s) and by one independent witness if the parent(s)/legal guardian(s) is illiterate
- Participants and parent(s)/legal guardian(s) are able to attend all scheduled visits and to comply with all trial procedures.
Exclusion Criteria:
- Participation in another clinical trial of an investigational product in the 4 weeks preceding the trial inclusion (receipt of study vaccine) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
- Group A participants diagnosed with a chronic condition, except HIV infection, or any experience of blood or blood-derived products received or experience of thrombocytopenia or bleeding disorder; and Group B participants diagnosed with chronic illness or any experience of blood or blood-derived products received or experience of thrombocytopenia or bleeding disorder.
- Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis (oral polio vaccine [OPV] given at birth does not constitute an exclusion criteria), hepatitis B (a birth dose of Hep B vaccine does not constitute an exclusion criteria) diseases or Hib infection with the trial vaccine or another vaccine. Previous vaccination with Bacillus Calmette-Guerin (BCG) is not considered an exclusion criterion
- History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Haemophilus influenzae type b infections (confirmed either clinically, serologically or microbiologically)
- History of seizures or history of uncontrolled neurologic disorder or uncontrolled epilepsy until treatment for the condition has been established, the condition has stabilized and the benefit clearly outweighs the risk
- Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
- Febrile (axillary temperature ≥ 38°C) or acute illness on the day of inclusion (temporary contraindication).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Study Group A
Study Group B
Arm Description
HIV exposed and infected infants
HIV exposed and uninfected infants
Outcomes
Primary Outcome Measures
Number of Participants with Anti-Pertussis Toxoid (PT) and Anti-Filamentous Hemagglutinin (FHA) Antibody (Ab) Concentrations >= Lower Limit of Quantification (LLOQ) and >=4*LLOQ at Baseline
Anti-PT and anti-FHA Ab concentrations are determined in terms of endotoxin units per millilitre (EU/mL).
Geometric Means of Anti-Pertussis Toxoid and Anti-Filamentous Hemagglutinin Antibody Concentrations at Baseline
Anti-PT and anti-FHA Ab levels are measured by electrochemiluminescence immunoassay (ECL) and anti-PT and anti-FHA Ab concentrations are determined in terms of EU/mL.
Geometric Means of Antibody Titers/Concentrations After Primary Series Vaccination
Anti-diphtheria, anti-tetanus, anti-PT and anti-FHA Ab levels are measured by ECL. Anti-poliovirus types 1, 2, and 3 Ab levels are measured by neutralisation assay. Anti-Hep B Ab levels are measured by VITROS ECi/ECiQ Immunodiagnostic system using chemiluminescence detection technology. Anti-polyribosylribitol phosphate (PRP) Ab levels are measured using a Farr-type radioimmunoassay (RIA). Ab concentrations are determined as: anti-diphtheria >=0.01 international units (IU)/mL, >=0.1 IU/mL, 1.0 IU/mL, anti-tetanus >=0.01 IU/mL, >=0.1 IU/mL, and >=1.0 IU/mL, anti-PT and anti-FHA EU/mL, anti-PRP >=0.15 microgram (mcg)/mL, >=1.0 mcg/mL, anti-Poliovirus types 1, 2, and 3 Ab titers >=8 (1/dilution [dil]), Anti-Hep B >=10 milli (m) IU/mL, and >=100 mIU/mL.
Number of Participants With Seroprotection After Primary Series Vaccination
Seroprotection is determined as: anti-diptheria Ab concentrations >=0.01 IU/mL, >=0.1 IU/mL, and >=1.0 IU/mL, anti-tetanus Ab concentrations >=0.01 IU/mL, >=0.1 IU/mL, and >=1.0 IU/mL, anti-PT and anti-FHA Ab concentrations EU/mL (>=LLOQ and >=4*LLOQ), anti-PRP Ab concentrations >=0.15 mcg/mL and >=1.0 mcg/mL, anti-poliovirus 1, 2, and 3 Ab titers >=8 (1/dil), anti-Hep B Ab concentrations >=10 mIU/mL and >=100 mIU/mL.
Number of Participants with Vaccine Response or Seroconversion After Primary Series Vaccination
Vaccine response is defined for anti-PT and anti-FHA as Ab post-Dose 3 concentrations >=4*LLOQ, if pre-Dose (Day 0) Ab concentration is <4*LLOQ or 1 month after third dose (Day 90) concentrations >= pre-Dose Ab concentrations if pre-Dose (Day 0) concentrations >=4*LLOQ. Seroconversion for anti-PT and anti-FHA is defined as >=4-fold Ab concentrations increase from pre-Dose (Day 0) to 1 month after third dose (Day 90).
Geometric Means of Antibody Titers/Concentrations After Booster Vaccination
Anti-diphtheria, anti-tetanus, anti-PT, and anti-FHA Ab levels are measured by ECL. Anti-poliovirus types 1, 2, and 3 Ab levels are measured by neutralisation assay. Anti-Hep B Ab levels are measured by VITROS ECi/ECiQ Immunodiagnostic system using chemiluminescence detection technology. Anti-PRP Ab levels are measured using a Farr-type RIA. Ab concentrations: anti-diphtheria >=0.01 IU/mL, >=0.1 IU/mL, >=1.0 IU/mL, anti-tetanus >=0.01 IU/mL, >=0.1 IU/mL, and >=1.0 IU/mL, anti-PT and anti-FHA EU/mL, anti-PRP >=0.15 mcg/mL, >=1.0 mcg/mL, anti-poliovirus 1, 2, and 3 Ab titers >=8 (1/dil), anti-Hep B >=10 mIU/mL, and >=100 mIU/mL.
Number of Participants With Seroprotection After Booster Vaccination
Seroprotection: anti-diphtheria Ab concentrations >=0.01 IU/mL, >=0.1 IU/mL, and >=1.0 IU/mL, anti-tetanus Ab concentrations >=0.01 IU/mL, >=0.1 IU/mL, and >=1.0 IU/mL, anti-PT and anti-FHA Ab concentrations EU/mL (>=LLOQ and >=4*LLOQ), anti-PRP Ab concentrations >=0.15 mcg/mL and >=1.0 mcg/mL, anti-poliovirus 1, 2, and 3 Ab titers >=8 (1/dil), and anti-Hep B Ab concentrations >=10 mIU/mL and >=100 mIU/mL.
Number of Participants With Vaccine Response or Seroconversion After Booster Vaccination
Vaccine response is defined for anti-PT and anti-FHA as >=4 fold Ab concentrations increase from pre-dose (Day 0) to 1 month after booster dose (Day 420), if pre-Dose (Day 0) Ab concentrations <4*LLOQ; or >=2 fold Ab concentrations increase from pre- dose (Day 0) to 1 month after booster dose (Day 420), if pre-dose (Day 0) Ab concentrations >=4*LLOQ. Seroconversion is defined for anti-PT and anti-FHA as >=4 fold Ab concentrations increase from pre-dose (Day 0) to 1 month after booster dose.
Number of Participants With Booster Response After Booster Vaccination
Booster response is defined for anti-PT and anti-FHA as >=4 fold Ab concentrations increase from pre-booster (Day 390) to 1 month after booster dose (Day 420), if pre-booster Ab concentrations <4*LLOQ; or >=2 fold Ab concentrations increase from pre-booster (Day 390) to 1 month after booster dose (Day 390) if pre-Booster Ab concentrations >=4*LLOQ.
Secondary Outcome Measures
Number of Participants With Immediate Unsolicited Adverse Events (AE) After Primary Series Vaccination
An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the electronic case report form (eCRF) in terms of diagnosis and/or onset post-vaccination.
Number of Participants With Solicited Injections Site or Systemic Reactions After Primary Series Vaccination
A solicited reaction is an adverse reaction observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the eCRF and considered as related to vaccination. Solicited injection site reactions: injection site tenderness, erythema, and swelling. Solicited systemic reactions: fever, vomiting, crying abnormal, drowsiness, appetite lost, and irritability
Number of Participants With Unsolicited Adverse Events After Primary Series Vaccination
An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of diagnosis and/or onset post-vaccination. An unsolicited non-serious AE is an unsolicited AE excluding serious adverse events (SAEs). Systemic AEs are all AEs that are not injection site reactions. They therefore include systemic manifestations such as headache, fever, as well as localized or topical manifestations that are not associated with the vaccination site.
Number of Participants With Serious Adverse Events During the Study
An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event.
Number of Participants With Immediate Unsolicited Adverse Events After Booster Vaccination
An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of diagnosis and/or onset post-vaccination.
Number of Participants With Solicited Injection Site or Systemic Reactions After Booster Vaccination
A solicited reaction is an adverse reaction observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the eCRF and considered as related to vaccination. Solicited injection site reactions: tenderness, erythema, swelling, and extensive limb swelling. Solicited systemic reactions: fever, vomiting, crying abnormal, drowsiness, appetite lost, and irritability.
Number of Participants With Unsolicited Adverse Events After Booster Vaccination
An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of diagnosis and/or onset post-vaccination. An unsolicited non-serious AE is an unsolicited AE excluding SAEs. Systemic AEs are all AEs that are not injection site reactions. They therefore include systemic manifestations such as headache, fever, as well as localized or topical manifestations that are not associated with the vaccination site.
Full Information
NCT ID
NCT02817451
First Posted
June 27, 2016
Last Updated
March 24, 2022
Sponsor
Sanofi Pasteur, a Sanofi Company
1. Study Identification
Unique Protocol Identification Number
NCT02817451
Brief Title
DTaP-IPV-HB-PRP-T Combined Vaccine as a Primary Series and a Second Year of Life Booster in HIV-Exposed Infected and Uninfected Infants
Official Title
Immunogenicity and Safety of Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Given as a Primary Series and a Second Year of Life Booster in HIV-Exposed Infected and in HIV-Exposed Uninfected Infants in Republic of South Africa
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
July 14, 2016 (Actual)
Primary Completion Date
February 22, 2019 (Actual)
Study Completion Date
February 22, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to assess and confirm the adequate immunogenicity and safety profile of the Sanofi Pasteur's DTaP-Hep B-IPV-PRP-T fully liquid combined hexavalent vaccine administered in HIV-exposed uninfected infants and in HIV-exposed infected infants.
The primary objectives of the study are:
To evaluate the immunogenicity of the study vaccine 1 month after the 3-dose primary series in HIV-exposed infected and in HIV-exposed uninfected infants.
To describe the persistence of all antibodies before receipt of the booster dose in HIV-exposed infected and in HIV-exposed uninfected infants.
To evaluate the immunogenicity of the study vaccine 1 month after the booster dose in HIV-exposed infected and in HIV-exposed uninfected infants.
The secondary objectives of the study are:
To describe the safety profile after each and all doses of the study vaccine administered as a 3-dose infant primary series in HIV-exposed infected and in HIV-exposed uninfected infants.
To describe the safety profile of the study vaccine administered as a booster in HIV-exposed infected and in HIV-exposed uninfected infants.
Detailed Description
Male and female infants born from HIV-infected mothers will be tested for HIV infection from birth to 6 weeks of age. HIV infected and HIV uninfected participants will be enrolled into two groups at Day 0. Some infants detected HIV-exposed infected outside of the hospital center facilities and the trial screening procedure may also be enrolled. All participants will receive primary vaccinations with Sanofi Pasteur's DTaP-IPV-HB-PRP-T combined vaccine at 6, 10 and 14 weeks of age and a booster dose at approximately 15 to 18 months of age will receive a booster dose of the Sanofi Pasteur's DTaP-IPV-HB-PRP-T combined vaccine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diphtheria, Tetanus, Pertussis, Hepatitis B, Polio, Human Immunodeficiency Virus Infection
Keywords
Diphtheria, Tetanus, Pertussis, Hepatitis B, DTaP IPV HB PRP-T Combined Vaccine, Human Immunodeficiency Virus
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study Group A
Arm Type
Experimental
Arm Description
HIV exposed and infected infants
Arm Title
Study Group B
Arm Type
Experimental
Arm Description
HIV exposed and uninfected infants
Intervention Type
Biological
Intervention Name(s)
Hexaxim®: DTaP-IPV-HB-PRP-T Combined Vaccine
Other Intervention Name(s)
Hexaxim®
Intervention Description
0.5 mL, Intramuscular at 6, 10, and 14 weeks of age + a booster at age 15 to 18 months
Intervention Type
Biological
Intervention Name(s)
Hexaxim®: DTaP-IPV-HB-PRP-T Combined Vaccine
Other Intervention Name(s)
Hexaxim®
Intervention Description
0.5 mL, Intramuscular at 6, 10, and 14 weeks of age + a booster at age 15 to 18 months
Primary Outcome Measure Information:
Title
Number of Participants with Anti-Pertussis Toxoid (PT) and Anti-Filamentous Hemagglutinin (FHA) Antibody (Ab) Concentrations >= Lower Limit of Quantification (LLOQ) and >=4*LLOQ at Baseline
Description
Anti-PT and anti-FHA Ab concentrations are determined in terms of endotoxin units per millilitre (EU/mL).
Time Frame
Day 0 (baseline)
Title
Geometric Means of Anti-Pertussis Toxoid and Anti-Filamentous Hemagglutinin Antibody Concentrations at Baseline
Description
Anti-PT and anti-FHA Ab levels are measured by electrochemiluminescence immunoassay (ECL) and anti-PT and anti-FHA Ab concentrations are determined in terms of EU/mL.
Time Frame
Day 0 (baseline)
Title
Geometric Means of Antibody Titers/Concentrations After Primary Series Vaccination
Description
Anti-diphtheria, anti-tetanus, anti-PT and anti-FHA Ab levels are measured by ECL. Anti-poliovirus types 1, 2, and 3 Ab levels are measured by neutralisation assay. Anti-Hep B Ab levels are measured by VITROS ECi/ECiQ Immunodiagnostic system using chemiluminescence detection technology. Anti-polyribosylribitol phosphate (PRP) Ab levels are measured using a Farr-type radioimmunoassay (RIA). Ab concentrations are determined as: anti-diphtheria >=0.01 international units (IU)/mL, >=0.1 IU/mL, 1.0 IU/mL, anti-tetanus >=0.01 IU/mL, >=0.1 IU/mL, and >=1.0 IU/mL, anti-PT and anti-FHA EU/mL, anti-PRP >=0.15 microgram (mcg)/mL, >=1.0 mcg/mL, anti-Poliovirus types 1, 2, and 3 Ab titers >=8 (1/dilution [dil]), Anti-Hep B >=10 milli (m) IU/mL, and >=100 mIU/mL.
Time Frame
Day 90 (1 month after third dose)
Title
Number of Participants With Seroprotection After Primary Series Vaccination
Description
Seroprotection is determined as: anti-diptheria Ab concentrations >=0.01 IU/mL, >=0.1 IU/mL, and >=1.0 IU/mL, anti-tetanus Ab concentrations >=0.01 IU/mL, >=0.1 IU/mL, and >=1.0 IU/mL, anti-PT and anti-FHA Ab concentrations EU/mL (>=LLOQ and >=4*LLOQ), anti-PRP Ab concentrations >=0.15 mcg/mL and >=1.0 mcg/mL, anti-poliovirus 1, 2, and 3 Ab titers >=8 (1/dil), anti-Hep B Ab concentrations >=10 mIU/mL and >=100 mIU/mL.
Time Frame
Day 90 (1 month after third dose)
Title
Number of Participants with Vaccine Response or Seroconversion After Primary Series Vaccination
Description
Vaccine response is defined for anti-PT and anti-FHA as Ab post-Dose 3 concentrations >=4*LLOQ, if pre-Dose (Day 0) Ab concentration is <4*LLOQ or 1 month after third dose (Day 90) concentrations >= pre-Dose Ab concentrations if pre-Dose (Day 0) concentrations >=4*LLOQ. Seroconversion for anti-PT and anti-FHA is defined as >=4-fold Ab concentrations increase from pre-Dose (Day 0) to 1 month after third dose (Day 90).
Time Frame
Day 0 (baseline), Day 90 (1 month after third dose)
Title
Geometric Means of Antibody Titers/Concentrations After Booster Vaccination
Description
Anti-diphtheria, anti-tetanus, anti-PT, and anti-FHA Ab levels are measured by ECL. Anti-poliovirus types 1, 2, and 3 Ab levels are measured by neutralisation assay. Anti-Hep B Ab levels are measured by VITROS ECi/ECiQ Immunodiagnostic system using chemiluminescence detection technology. Anti-PRP Ab levels are measured using a Farr-type RIA. Ab concentrations: anti-diphtheria >=0.01 IU/mL, >=0.1 IU/mL, >=1.0 IU/mL, anti-tetanus >=0.01 IU/mL, >=0.1 IU/mL, and >=1.0 IU/mL, anti-PT and anti-FHA EU/mL, anti-PRP >=0.15 mcg/mL, >=1.0 mcg/mL, anti-poliovirus 1, 2, and 3 Ab titers >=8 (1/dil), anti-Hep B >=10 mIU/mL, and >=100 mIU/mL.
Time Frame
Day 420 (1 month after booster vaccination)
Title
Number of Participants With Seroprotection After Booster Vaccination
Description
Seroprotection: anti-diphtheria Ab concentrations >=0.01 IU/mL, >=0.1 IU/mL, and >=1.0 IU/mL, anti-tetanus Ab concentrations >=0.01 IU/mL, >=0.1 IU/mL, and >=1.0 IU/mL, anti-PT and anti-FHA Ab concentrations EU/mL (>=LLOQ and >=4*LLOQ), anti-PRP Ab concentrations >=0.15 mcg/mL and >=1.0 mcg/mL, anti-poliovirus 1, 2, and 3 Ab titers >=8 (1/dil), and anti-Hep B Ab concentrations >=10 mIU/mL and >=100 mIU/mL.
Time Frame
Day 420 (1 month after booster vaccination)
Title
Number of Participants With Vaccine Response or Seroconversion After Booster Vaccination
Description
Vaccine response is defined for anti-PT and anti-FHA as >=4 fold Ab concentrations increase from pre-dose (Day 0) to 1 month after booster dose (Day 420), if pre-Dose (Day 0) Ab concentrations <4*LLOQ; or >=2 fold Ab concentrations increase from pre- dose (Day 0) to 1 month after booster dose (Day 420), if pre-dose (Day 0) Ab concentrations >=4*LLOQ. Seroconversion is defined for anti-PT and anti-FHA as >=4 fold Ab concentrations increase from pre-dose (Day 0) to 1 month after booster dose.
Time Frame
Day 0 (baseline), Day 420 (1 month after booster vaccination)
Title
Number of Participants With Booster Response After Booster Vaccination
Description
Booster response is defined for anti-PT and anti-FHA as >=4 fold Ab concentrations increase from pre-booster (Day 390) to 1 month after booster dose (Day 420), if pre-booster Ab concentrations <4*LLOQ; or >=2 fold Ab concentrations increase from pre-booster (Day 390) to 1 month after booster dose (Day 390) if pre-Booster Ab concentrations >=4*LLOQ.
Time Frame
Day 390 (pre-booster), Day 420 (1 month after booster dose)
Secondary Outcome Measure Information:
Title
Number of Participants With Immediate Unsolicited Adverse Events (AE) After Primary Series Vaccination
Description
An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the electronic case report form (eCRF) in terms of diagnosis and/or onset post-vaccination.
Time Frame
Within 30 minutes after vaccination
Title
Number of Participants With Solicited Injections Site or Systemic Reactions After Primary Series Vaccination
Description
A solicited reaction is an adverse reaction observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the eCRF and considered as related to vaccination. Solicited injection site reactions: injection site tenderness, erythema, and swelling. Solicited systemic reactions: fever, vomiting, crying abnormal, drowsiness, appetite lost, and irritability
Time Frame
Within 7 days after vaccination
Title
Number of Participants With Unsolicited Adverse Events After Primary Series Vaccination
Description
An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of diagnosis and/or onset post-vaccination. An unsolicited non-serious AE is an unsolicited AE excluding serious adverse events (SAEs). Systemic AEs are all AEs that are not injection site reactions. They therefore include systemic manifestations such as headache, fever, as well as localized or topical manifestations that are not associated with the vaccination site.
Time Frame
Within 30 days after vaccination
Title
Number of Participants With Serious Adverse Events During the Study
Description
An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event.
Time Frame
Day 0 to Day 420
Title
Number of Participants With Immediate Unsolicited Adverse Events After Booster Vaccination
Description
An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of diagnosis and/or onset post-vaccination.
Time Frame
Within 30 minutes after booster vaccination
Title
Number of Participants With Solicited Injection Site or Systemic Reactions After Booster Vaccination
Description
A solicited reaction is an adverse reaction observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the eCRF and considered as related to vaccination. Solicited injection site reactions: tenderness, erythema, swelling, and extensive limb swelling. Solicited systemic reactions: fever, vomiting, crying abnormal, drowsiness, appetite lost, and irritability.
Time Frame
Within 7 days after booster vaccination
Title
Number of Participants With Unsolicited Adverse Events After Booster Vaccination
Description
An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of diagnosis and/or onset post-vaccination. An unsolicited non-serious AE is an unsolicited AE excluding SAEs. Systemic AEs are all AEs that are not injection site reactions. They therefore include systemic manifestations such as headache, fever, as well as localized or topical manifestations that are not associated with the vaccination site.
Time Frame
Within 30 days after booster vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Weeks
Maximum Age & Unit of Time
8 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
(Screening Criteria for the participants mother)
At least 18 years of age at the time of the Screening blood sample draw
Self-reported or maternity-reported HIV infection in the mother
Inclusion Criteria:
Born to an adult mother and aged 35 to 56 days (between 5 and 8 weeks of age) on the day of inclusion
Group A participants must be HIV infected, as documented through the results of a polymerase chain reaction (PCR) test, and following an anti-retroviral therapy according to the national recommendations; and Group B participants must be HIV exposed uninfected infants, as documented through the results of a PCR test.
Born with a birth weight ≥ 2.0 kg
Informed consent form signed by the parent(s)/legal guardian(s) and by one independent witness if the parent(s)/legal guardian(s) is illiterate
Participants and parent(s)/legal guardian(s) are able to attend all scheduled visits and to comply with all trial procedures.
Exclusion Criteria:
Participation in another clinical trial of an investigational product in the 4 weeks preceding the trial inclusion (receipt of study vaccine) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
Group A participants diagnosed with a chronic condition, except HIV infection, or any experience of blood or blood-derived products received or experience of thrombocytopenia or bleeding disorder; and Group B participants diagnosed with chronic illness or any experience of blood or blood-derived products received or experience of thrombocytopenia or bleeding disorder.
Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis (oral polio vaccine [OPV] given at birth does not constitute an exclusion criteria), hepatitis B (a birth dose of Hep B vaccine does not constitute an exclusion criteria) diseases or Hib infection with the trial vaccine or another vaccine. Previous vaccination with Bacillus Calmette-Guerin (BCG) is not considered an exclusion criterion
History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Haemophilus influenzae type b infections (confirmed either clinically, serologically or microbiologically)
History of seizures or history of uncontrolled neurologic disorder or uncontrolled epilepsy until treatment for the condition has been established, the condition has stabilized and the benefit clearly outweighs the risk
Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
Febrile (axillary temperature ≥ 38°C) or acute illness on the day of inclusion (temporary contraindication).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi Pasteur SA
Official's Role
Study Director
Facility Information:
City
Soweto
Country
South Africa
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Learn more about this trial
DTaP-IPV-HB-PRP-T Combined Vaccine as a Primary Series and a Second Year of Life Booster in HIV-Exposed Infected and Uninfected Infants
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