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)

Inclusion Criteria:

Phase 1

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.
2. Toddlers in good health, as determined by their medical history, physical examination and the clinical judgment of the Investigator.
3. Toddlers with weight-for-length z-score is ≥ -2 Standard Deviation (SD) at the time of enrolment.
4. Toddler's parent(s) willingness and ability to comply with the requirements of the protocol.
5. Informed consent signed by at least one parent.

Phase 2

1. Male or female infants aged 6-8 weeks at the time of first vaccination.
2. Infants with good health, as determined by the medical history, physical examination and clinical judgment of the Investigator.
3. Infants who are OPV naive.
4. Informed consent form signed by at least one parent.
5. Infants born at full term pregnancy (≥ 37 weeks).
6. Infants with weight-for-length z-score ≥ -2 SD at the time of enrolment.
7. Willingness of participant's parent(s) to comply with the requirements of the protocol.

Exclusion Criteria:

Phase 1

1. History of diphtheria/tetanus/pertussis/hepatitis B/Haemophilus influenzae type b/poliomyelitis infection(s).

2. Presence of fever ≥ 38°C/100.4°F within 48 hours.

3. Acute illness of moderate to severe intensity according to the clinical judgment of the investigator.

4. 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.

5. 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.

6. History of anaphylaxis, or any serious vaccine reaction, or hypersensitivity/allergy to any vaccine or components of IMPs.

7. 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.

8. History of major congenital defects or developmental disorders or genetic diseases as determined by medical history or clinical assessment.

9. History of thrombocytopenia or a bleeding disorder following IM administration.

10. 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.

11. 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.

12. Receipt of antibiotics in the past 3 days.

13. Family history of any medical conditions, that in the investigator's opinion, could affect the trial outcomes.

14. Presence of evolving or changing neurological disorder or toddler with a history of seizures and/or encephalopathy.

15. Known personal or maternal history of Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C seropositivity.

16. Planned surgery during the trial.

17. 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.

18. Participation in another clinical trial 4 weeks preceding the trial enrolment or planned participation during the present trial period in another clinical trial.

19. Toddlers whose families are planning to leave the area of the trial site before the end of the trial period.

Phase 2

1. History of diphtheria/tetanus/pertussis/hepatitis B/Haemophilus influenzae type b/poliomyelitis infection(s).
2. Presence of fever ≥ 38°C/100.4°F within 48 hours.
3. 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.
4. Acute illness of moderate to severe intensity according to the clinical judgment of the investigator.
5. Administration of any vaccine in the 4 weeks (except BCG) preceding the first dose of IMP administration.
6. Receipt of antibiotics in the past 3 days.
7. History of major congenital defects or illness that require medical therapy, as determined by medical history or clinical assessment.
8. History of any clinically significant chronic disease that in the opinion of the Investigator, might interfere with the evaluation of the trial objectives.
9. History of anaphylaxis, or any serious vaccine reaction, or hypersensitivity/allergy to any vaccine or components of IMP.
10. 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.
11. Presence of evolving or changing neurological disorder or infant with a history of seizures and/or encephalopathy.
12. Known thrombocytopenia or a bleeding disorder.
13. Planned surgery during the trial.
14. Known personal or maternal history of HIV, Hepatitis B or Hepatitis C seropositivity.
15. 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.
16. Participation in another clinical trial 4 weeks preceding the trial enrolment or planned participation during the present trial period in another clinical trial.
17. Infants whose families are planning to leave the area of the trial site before the end of the trial period.