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DTaP-IPV-HB-PRP-T Combined Vaccine as a Primary Series and a 2nd Year of Life Booster in HIV-Exposed Infected and Uninfected Infants

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ClinicalTrials.gov Identifier: NCT02817451
Recruitment Status : Active, not recruiting
First Posted : June 29, 2016
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Brief Summary:

Study is 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 (HIV-exposed uninfected) and in HIV-exposed infected infants (HIV-exposed infected).

Primary Objectives:

  • 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 vaccination 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.

Secondary Objectives

  • 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.

Condition or disease Intervention/treatment Phase
Diphtheria Tetanus Pertussis Hepatitis B Polio Human Immunodeficiency Virus Infection Biological: Hexaxim®: DTaP-IPV-HB-PRP-T Combined Vaccine Phase 3

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 will be detected outside of this screening and will already have proof of HIV infection, and will be enrolled in the study at Day 0. 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : July 14, 2016
Estimated Primary Completion Date : September 11, 2018
Estimated Study Completion Date : August 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Study Group A
HIV exposed and infected infants
Biological: Hexaxim®: DTaP-IPV-HB-PRP-T Combined Vaccine
0.5 mL, Intramuscular at 6, 10, and 14 weeks of age + a booster at age 15 to 18 months
Other Name: Hexaxim®

Experimental: Study Group B
HIV exposed and uninfected infants
Biological: Hexaxim®: DTaP-IPV-HB-PRP-T Combined Vaccine
0.5 mL, Intramuscular at 6, 10, and 14 weeks of age + a booster at age 15 to 18 months
Other Name: Hexaxim®




Primary Outcome Measures :
  1. Number of participants with anti-Pertussis toxoid and anti-Filamentous Hemagglutinin antibody concentrations ≥ Lower Limit of Quantitation (LLOQ) and ≥ 4 x LLOQ at baseline [ Time Frame: Day 0 (pre-vaccination) ]
  2. Number of participants with vaccine response for pertussis toxoid and Filamentous Hemagglutinin antigens post vaccination with Sanofi Pasteur's DTaP-IPV-HB-PRP-T combined vaccine. [ Time Frame: Day 21 post-dose 3 ]
    Vaccine response defined as post-third dose anti-Pertussis toxoid and anti-Filamentous Hemagglutinin antibody concentrations ≥ 4 x LLOQ if pre-vaccination concentration is < 4 x LLOQ or ≥ pre-vaccination concentration if pre-vaccination concentrations ≥ 4 x LLOQ

  3. Number of participants with ≥ 4-fold increase in anti-Pertussis toxoid and anti-filamentous Hemagglutinin antibody concentrations (EU/mL) from pre-dose 1 to one month post-dose 3 vaccination with Sanofi Pasteur's DTaP-IPV-HB-PRP-T combined vaccine. [ Time Frame: Day 21 post-dose 3 ]
  4. Number of participants with anti-Diphtheria antibody concentrations ≥ 0.01 and ≥ 0.1 IU/mL International Units (IU)/mL post-third dose vaccination [ Time Frame: Day 21 post-dose 3 ]

Secondary Outcome Measures :
  1. Number of subjects reporting solicited injection-site reactions, solicited systemic reactions, unsolicited systemic reactions and serious adverse events occurring throughout the trial [ Time Frame: Day 0 up to 14 months post-vaccination ]
    Solicited injection-site reactions: Tenderness, Redness, and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Abnormal Crying, Drowsiness, Loss of Appetite, and Irritability; and unsolicited adverse events.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Weeks to 8 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

(Screening Criteria)

  • At least 18 years of age at the time of the subject's PCR 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 subjects must be HIV infected, as documented through the results of a PCR test, and following an anti-retroviral therapy according to the national recommendations; and Group B subjects 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
  • Subject 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 subjects 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 subjects 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02817451


Locations
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South Africa
Soweto, South Africa
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Medical Director Sanofi Pasteur SA

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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT02817451     History of Changes
Other Study ID Numbers: A3L44
U1111-1161-2610 ( Other Identifier: WHO )
First Posted: June 29, 2016    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) and supporting clinical documents are available for request at www.clinicalstudydatarequest.com. While making information available we continue to protect the privacy of the participants in our clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: Clinicalstudydatarequest.com/Sanofi".

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Diphtheria
Tetanus
Pertussis
Hepatitis B
DTaP IPV HB PRP-T Combined Vaccine
Human Immunodeficiency Virus

Additional relevant MeSH terms:
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Hepatitis
Hepatitis B
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Virus Diseases
Whooping Cough
Tetanus
Diphtheria
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Viral, Human
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Corynebacterium Infections