Clareo Health | 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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi Pasteur, a Sanofi Company
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.
Age
0–0
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
(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
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.
You may not be if
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.
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).
