A clinical study to assess immunogenicity and safety of diphtheria, tetanus, pertussis, hepatitis B, polio and Haemophilus influenzae combination vaccine in young children.
- Conditions
- Health Condition 1: Z23- Encounter for immunization
- Registration Number
- CTRI/2019/11/022052
- Lead Sponsor
- Serum Institute of India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1548
For Part I (Toddler)
1.Toddlers aged between 12-24 months at the time of vaccination.
2.Toddlers with a good health, as determined by the medical history, physical examination and clinical judgment of the Investigator.
3.Toddlers who have completed primary immunization series against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus Influenzae type b at least 6 months prior to enrolment and have not received the booster dose for the above-mentioned vaccines scheduled at 12-24 months of age.
4.Informed consent form signed by at least one parent.
5.The weight-for-length z-score for the toddler is greater than or equal to -2 Standard Deviation at the time of enrolment.
6.Willingness of subjects’ parent to comply with requirements of the protocol.
For Part II (Infant)
1.Male or female infants aged 6-8 weeks at the time of first vaccination.
2.Infants with a good health, as determined by the medical history, physical examination and clinical judgment of the Investigator.
3.Infants who have received the birth doses of OPV and BCG at least 4 weeks before the first trial vaccination.
4.Informed consent form signed by at least one parent.
5.Infants born at full term pregnancy (greater than or equal to 37 weeks).
6.Infants with weight-for-length z-score greater than or equal to -2 SD at the time of enrolment.
7.Willingness of subjects’ parent to comply with requirements of the protocol.
1.History of diphtheria/tetanus/pertussis/hepatitis B/Haemophilus Influenzae type b/poliomyelitis infection(s) (confirmed either clinically, serologically or microbiologically).
2.Fever greater than or equal to 38°C/100.4°F and/or any evidence of acute illness and/or receipt of antibiotics in the past 3 days.
3.History of major congenital defects or illness that require medical therapy, as determined by medical history or clinical assessment.
4.History of any clinically significant chronic disease that in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
5.History of anaphylaxis, or any serious vaccine reaction, or hypersensitivity/allergy to any vaccine or components of study vaccine.
6.Presence of evolving or changing neurological disorder or toddler/infants with a history of seizures and/or encephalopathy.
7.Known thrombocytopenia or a bleeding disorder.
8.Known personal or maternal history of Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C seropositivity.
9.Planned surgery during the study.
10.Participation in another clinical trial 4 weeks preceding the trial enrolment or planned participation during the present trial period in another clinical trial.
11.Toddlers/infants whose families are planning to leave the area of the study site before the end of the study period.
Specific to Part I (Toddler)
12.Administration of any vaccine (except OPV during government immunization campaign) in the 4 weeks preceding the trial vaccination or planned receipt of any non-study vaccine during the study period.
13.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 study entry
14.Receipt of blood or blood-derived products or immunoglobulins in the past 3 months, current or planned administration during the study period.
Specific to Part II (Infant)
12.Previous vaccination or planned receipt of any vaccine against diphtheria, tetanus, pertussis, hepatitis B (except birth dose), poliomyelitis (except OPV birth dose) or Haemophilus Influenzae type b infection apart from trial vaccines during the study period.
13.Administration of any vaccine (except OPV during government immunization campaign) in the 4 weeks preceding the first trial vaccination.
14.Planned receipt of any other vaccine within the period from 7 days before to 7 days after each trial vaccination.
15.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
16.Receipt of blood or blood-derived products or immunoglobulins or planned administration during trial which might interfere with assessment of immune response.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method For Part I: <br/ ><br>1. Occurrence, severity, and relationship of local and systemic solicited and unsolicited adverse events. <br/ ><br>For Part II : <br/ ><br>1. Percentage of infants achieving seroprotection for diphtheria, tetanus, hepatitis B, Haemophilus influenzae type b and seroconversion for poliovirus types 1, 3 and pertussis, 28 days post completion of a 3 dose primary vaccination series.Timepoint: For Part I: <br/ ><br>1. Solicited reactions up to 7 days and Unsolicited <br/ ><br>Events up to 28 days of vaccination <br/ ><br>For Part II : <br/ ><br>1. 28 days post completion of a 3 dose primary vaccination series.
- Secondary Outcome Measures
Name Time Method For Part I : Immunogenicity (Seroprotection/seroresponse <br/ ><br>rates and GMCs/GMTs) <br/ ><br>For Part II : <br/ ><br>1. Safety after each study vaccination 2. Immunogenicity of 3 lots of SIIPL HEXASIIL vaccineTimepoint: For Part I : 28 days following vaccination <br/ ><br>For Part II : 1. 28 days following each vaccination. 2. 28 days post completion of a 3 dose primary vaccination series