A clinical study to evaluate safety and compare immune responses of two formulations of a combined 5-in-1 DTwP-HepB-Hib vaccine in childre
- Registration Number
- CTRI/2018/12/016692
- Lead Sponsor
- Shantha Biotechnics Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 460
For Infants (Stage 1):
1.Infants between 6-8 weeks of age on the day of enrollment.
2.Healthy infants, born at full term of pregnancy (not less than 37 weeks) with a birth weight not less than 2.5 kg
3.Informed consent form signed by the parent or by the legally acceptable representative (LAR).
4.Subjects and Parent/LAR are able to attend all scheduled visits and to comply with all study procedures.
For Toddlers (Stage 2):
1.Toddlers aged between 12-24 months of age on the day of enrollment and had received either the investigational or the licensed SHAN 5�® vaccine formulation at 6-8, 10-12 and 14-16 weeks of age during stage 1 of the trial.
2.Informed consent form signed by the parent or by the LAR.
3.Subjects and Parent/LAR are able to attend all scheduled visits and to comply with all study procedures
1. Participation in another clinical trial in the 4 weeks preceding the trial inclusion or planned participation during the present trial period
2.Receipt of any vaccine in the 4 weeks preceding the first trial vaccination (except BCG, birth dose OPV and birth dose of Hep B vaccine).
3.Planned receipt of any other vaccine within the period from 8 days before to 8 days after each trial vaccination except OPV.
4.For Stage 1 only: Previous vaccination against the diphtheria, tetanus, pertussis, hepatitis B (except the birth dose of Hep B vaccine) or Haemophilus influenza type b infection with the trial vaccine or another vaccine.
5.For Stage 2 only: Previous booster dose vaccination against diphtheria, tetanus, pertussis, hepatitis B, or Haemophilus influenza type b infection with the trial vaccine or another vaccine.
6.Past or current receipt of immunoglobulins, blood or blood-derived products or planned administration during the trial.
7.Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, or long-term systemic corticosteroid therapy.
8.History of diphtheria, tetanus, pertussis, hepatitis B, or Haemophilus influenza type b infections.
9.Known personal or maternal history of HIV or hepatitis B seropositivity.
10.Known systemic hypersensitivity to any of the vaccine components, or history of a life threatening reaction to the trial vaccine or a vaccine containing the same substances.
11.Known thrombocytopenia.
12.Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, contradicting intramuscular vaccination.
13.Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion.
14.Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness on the day of inclusion.
15.Identified as a natural or adopted child of the Investigator, relatives or employee with direct involvement in the proposed study.
16.Subject with definite seizure disorder and getting anticonvulsant therapy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Immunogenicity in terms of Hep B seroprotection rate and pertussis immune responsesTimepoint: Baseline; 28 days after Dose-3 in infants
- Secondary Outcome Measures
Name Time Method Immunogenicity in terms of Seroprotection/seroresponse rates/GMCs for D,T,wP,HepB and Hib antigensTimepoint: Baseline; 28 days post Dose-3 in infants and 28 days after single dose in toddlers;Safety after each and after any study vaccine dose, as applicable.Timepoint: Immediate adverse events within 30 min, Solicited reactions within 7 days and Unsolicited Events within 28 days of vaccination.