Health Condition 1: Z23- Encounter for immunization
Conditions
Interventions
Intervention1: DTaPIPVHib vaccine by SIIPL: Dose:0.5ml, Single dose (at 15
to 18 months of age) in
Toddlers and 3 dose series (at
6-10-14 weeks of age) in
infants. Route:Intramuscular
Control Interven
Sponsors
Serum Institute of India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: For both Part I and Part II: 1. Subject of either sex with a good health, as determined by the medical history, physical examination and clinical judgment of the Investigator. 2. Informed consent form signed by at least one parent or legally acceptable representative. 3. Subject and parent/legally acceptable representative able to attend all scheduled visits and willing to comply with all study procedures during the entire duration of the trial. Additional inclusion criteria for Part I only: 4a. Subject is between 15-18 months of age at the time of vaccination. 5a. Subject who has completed primary immunization series against Diphtheria, Tetanus, Pertussis, Haemophilus influenzae type b and poliomyelitis (OPV and/or IPV) and has not received the booster dose scheduled at 15-18 months of age. 6a. The weight-for-length z-score for the subject is greater than or equal to -2 SD. Additional inclusion criteria for Part II only: 4b. Subject aged 6-8 weeks (42-56 days, both inclusive) at the time of first vaccination. 5b. Subject born at full term pregnancy (greater than or equal to 37 weeks) with a birth weight greater than or equal to 2.5 kg. 6b. Subject who have received the birth dose of OPV and BCG vaccine at least four weeks before the first trial vaccination.
Exclusion criteria
Exclusion criteria: For both Part I and Part II: 1. History of Diphtheria/Tetanus/Pertussis/Haemophilus influenzae type b/Poliomyelitis, Infection(s). 2. Presence of evolving or changing neurological disorder or subject with a history of seizures and/or encephalopathy. 3. Fever greater than or equal to 38°C/100.4°F in the past 7 days and/or any evidence of acute illness or infection within the past 7 days. 4. Planned surgery during the course of the study. 5. History of anaphylaxis, or any serious vaccine reaction, or hypersensitivity/allergy to any vaccine or constituent of study vaccine. 6. History of any clinically significant chronic disease such that in the opinion of the investigator, it might interfere with the evaluation of the study objectives. 7. History of major congenital defects or illness that require medical therapy, as determined by medical history or clinical assessment. 8. Known thrombocytopenia or a bleeding disorder. 9. Participation in another clinical trial 4 weeks preceding the trial enrolment or planned participation during the present trial period in another clinical trial. 10. Subject whose families are planning to leave the area of the study site before the end of the study period. 11. Known personal or maternal history of HIV, Hepatitis B or Hepatitis C seropositivity. Additional exclusion criteria for Part I only: 12a. Receipt of blood or blood-derived products or immunoglobulins in the past 3 months, current or planned administration during the trial. 13a. Subject 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 6 months prior to study entry 14a. Administration of any vaccine (except OPV during immunization campaign) in the 4 weeks preceding the trial vaccination or planned receipt of any non study vaccine during the study period. Additional exclusion criteria for Part II only: 12b. Receipt of any vaccine (except OPV during immunization campaign) in the 4 weeks preceding the first dose of trial vaccine. 13b. Previous or planned vaccination against diphtheria, tetanus, pertussis, poliomyelitis (except OPV) or Haemophilus influenzae type b infection apart from trial vaccines during the study period. 14b. 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. 15b. Subject 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 study entry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For Part I: 1. Occurrence of local and systemic solicited and unsolicited adverse events. For Part II : 1. Percentage of infants achieving seroprotection/seroconversion after 3 dose primary vaccination series.Timepoint: For Part I: 1. Any adverse event (AE) within 30 minutes, Solicited reactions up to 7 days and Unsolicited Events up to 28 days of vaccination and serious adverse event (SAE) during the study period For Part II : 1. 28 days post completion of a 3 dose primary vaccination series. | — |
Secondary
| Measure | Time frame |
|---|---|
| For Part I : Immunogenicity (Seroprotection/seroresponse rates and GMCs/GMTs) For Part II : 1. Safety after each study vaccination 2. Immunogenicity w.r.t. Geometric Mean Titre/Concentration (GMT/GMC)Timepoint: For Part I : 28 days following vaccination For Part II : 1. 28 days following each vaccination. 2. 28 days post completion of 3 dose primary vaccination series | — |
Countries
India
Contacts
Public ContactDr Hitt Sharma
Serum Institute Of India Pvt. Ltd.
Outcome results
None listed