Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)

Prior treatment

• History of administration of any investigational or non-registered product (drug or vaccine) within 4 weeks prior to administration of IMPs or planned during the course of trial participation.
• Administration of any vaccine (except OPV during government immunization campaign) in the 4 weeks preceding the IMP administration or planned receipt of any vaccine during the trial participation period.
• Receipt of a blood transfusion, other blood products, or immunoglobulins in 3 months prior to IMP administration, or planned administration during the active trial period.
• Planned surgery during the trial.
• Toddlers with a known or suspected impairment of the immune function, or those receiving immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy or received immunosuppressive therapy within 3 months prior to entry in the trial.
• Previous vaccination or planned receipt of any vaccine against diphtheria, tetanus, pertussis, hepatitis B (except birth dose), poliomyelitis or Haemophilus influenzae type b infection apart from IMPs during the trial period.
• Administration of any vaccine in the 4 weeks (except BCG) preceding the first dose of IMP administration.
• Infants with a known or suspected impairment of the immune function, or those receiving immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy or received immunosuppressive therapy prior to trial entry.
• Planned surgery during the trial.

Other illness

• History of diphtheria/tetanus/pertussis/hepatitis B/Haemophilus influenzae type b/poliomyelitis infection(s).
• Acute illness of moderate to severe intensity according to the clinical judgment of the investigator.
• History of anaphylaxis, or any serious vaccine reaction, or hypersensitivity/allergy to any vaccine or components of IMPs.
• History of following events that are known to have occurred in temporal relation to receipt of pertussis-containing vaccine:
  • temperature ≥40°C within 48 hours of vaccination, not due to another identifiable cause.
  • collapse or shock-like state (hypotonic-hyporesponsiveness episode) within 48 hours of vaccination.
  • persistent, inconsolable crying lasting ≥ 3 hours, occurring within 48 hours of vaccination.
• History of major congenital defects or developmental disorders or genetic diseases as determined by medical history or clinical assessment.
• History of thrombocytopenia or a bleeding disorder following IM administration.
• History or current evidence of any clinically significant chronic disease that in the opinion of the Investigator might interfere with the evaluation of trial objectives.
• Family history of any medical conditions, that in the investigator's opinion, could affect the trial outcomes.
• Presence of evolving or changing neurological disorder or toddler with a history of seizures and/or encephalopathy.
• Known personal or maternal history of Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C seropositivity.
• History of diphtheria/tetanus/pertussis/hepatitis B/Haemophilus influenzae type b/poliomyelitis infection(s).
• Acute illness of moderate to severe intensity according to the clinical judgment of the investigator.
• History of major congenital defects or illness that require medical therapy, as determined by medical history or clinical assessment.
• History of any clinically significant chronic disease that in the opinion of the Investigator, might interfere with the evaluation of the trial objectives.
• History of anaphylaxis, or any serious vaccine reaction, or hypersensitivity/allergy to any vaccine or components of IMP.
• Presence of evolving or changing neurological disorder or infant with a history of seizures and/or encephalopathy.
• Known thrombocytopenia or a bleeding disorder.
• Known personal or maternal history of HIV, Hepatitis B or Hepatitis C seropositivity.

Other

• Phase 1
• Presence of fever ≥ 38°C/100.4°F within 48 hours.
• Receipt of antibiotics in the past 3 days.
• Participation in another clinical trial 4 weeks preceding the trial enrolment or planned participation during the present trial period in another clinical trial.
• Toddlers whose families are planning to leave the area of the trial site before the end of the trial period.
  • Phase 2
• Presence of fever ≥ 38°C/100.4°F within 48 hours.
• Receipt of antibiotics in the past 3 days.
• Receipt of blood or blood-derived products or immunoglobulins or planned administration during the trial which might interfere with the assessment of the immune response.
• Participation in another clinical trial 4 weeks preceding the trial enrolment or planned participation during the present trial period in another clinical trial.
• Infants whose families are planning to leave the area of the trial site before the end of the trial period.

• Phase 1
• Male or female toddlers aged between 12-24 (both inclusive) months on the day of vaccination, who have completed primary immunization series against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis (Oral Polio Vaccine \[OPV\] and/or Inactivated Polio Vaccine \[IPV\]) and Haemophilus influenzae type b at least 6 months prior to enrolment and have not received the booster dose for the above-mentioned vaccines.
• Toddlers in good health, as determined by their medical history, physical examination and the clinical judgment of the Investigator.
• Toddlers with weight-for-length z-score is ≥ -2 Standard Deviation (SD) at the time of enrolment.
• Toddler's parent(s) willingness and ability to comply with the requirements of the protocol.
• Informed consent signed by at least one parent.
  • Phase 2
• Male or female infants aged 6-8 weeks at the time of first vaccination.
• Infants with good health, as determined by the medical history, physical examination and clinical judgment of the Investigator.
• Infants who are OPV naive.
• Informed consent form signed by at least one parent.
• Infants born at full term pregnancy (≥ 37 weeks).
• Infants with weight-for-length z-score ≥ -2 SD at the time of enrolment.
• Willingness of participant's parent(s) to comply with the requirements of the protocol.