A clinical study to assess immunogenicity and safety of diphtheria, tetanus, pertussis, hepatitis B,polio and Haemophilus influenzae combination vaccine in young childre
- Conditions
- Health Condition 1: Z23- Encounter for immunization
- Registration Number
- CTRI/2024/04/066095
- Lead Sponsor
- Serum Institute of India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1.Infants aged 6-8 weeks at the time of first vaccination.
2.Infants with good health.
3.Informed consent form signed by parent.
4.Infants born at full term pregnancy.
5.Infants with weight-for-length z-score = -2 SD at the time of enrolment.
6. Willingness of subject parent to comply with the the protocol.
1.History of diphtheria/ tetanus/ pertussis/ hepatitis B/Haemophilus Influenzae type b/ poliomyelitis infection(s).
2.Presence of fever.
3.Acute illness of moderate to severe intensity according to the clinical judgment of the investigator.
4.Receipt of antibiotics in the past 3 days.
5.Previous vaccination or planned receipt of any vaccine against D,T,P,HepB, (except birth dose),
poliomyelitis (except OPV birth dose) or Hib type b apart from trial vaccines.
6.Administration of any vaccine (except OPV during government immunization campaign) in the 4 weeks preceding the first trial vaccination.
7.History of major congenital defects or illness that require medical therapy.
8.History of any clinically significant chronic disease which may interfere with the study outcome.
9.History of anaphylaxis, or any serious vaccine reaction, or hypersensitivity/allergy to any vaccine or components of study vaccine.
10.Infants with known or suspected impairment of the immune function.
11.Presence of evolving or changing neurological disorder or infant with a history of seizures.
12.Known thrombocytopenia or a bleeding disorder.
13.Known personal or maternal history of HIV, Hepatitis B or Hepatitis C seropositivity.
14.Planned surgery during the study.
15.Receipt of blood or blood-derived products or immunoglobulins.
16.Participation in another clinical trial 4 weeks preceding the trial
enrolment or planned participation during the present trial period.
17.Infants whose families are planning to leave the area of the study site.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method on-inferiority of SIIPL reduced IPV <br/ ><br>HEXAVALENT vaccine in comparison with SIIPL HEXASIIL® <br/ ><br>vaccine in terms of seroprotection rate for diphtheria, tetanus, <br/ ><br>hepatitis B, Haemophilus Influenzae type b, polio and <br/ ><br>seroresponse/seroconversion rate for pertussis, 28 days post completion of a 3-dose primary vaccination series in infants aged 6-8 weeks.Timepoint: 1 month post completion of 3-dose primary vaccination series in infants.
- Secondary Outcome Measures
Name Time Method