Health Condition 1: Z23- Encounter for immunization
Conditions
Interventions
Intervention1: BEs Liquid Hexavalent (DTwP-rHepB-HIB-IPV) Liquid Vaccine: Each 0.5 mL will be administered intramuscularly in the anterolateral aspect of mid or upper thigh (vastus lateralis muscle) i
Sponsors
Biological E.Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Intended subjects will be healthy infants between 6-8 weeks of age (42-56 days, both inclusive), of either gender at the time of 1st vaccination. 2. Written or thumb printed informed consent obtained from the subject s parent(s) or legally acceptable representative prior to performing any study specific procedure. 3. Healthy infants with weight 3300gms at the time of 1st vaccination. 4. Good clinical condition established by medical history and physical examination (with no acute disease, infection or high temperature) as judged by the investigator. 5. Infants with a minimal vaccination status for their age at the time of enrolment (Receipt of single birth dose of BCG, OPV and HBV vaccines (within 14 days of birth)). 6. Infants without contraindications or precautionary circumstances for participating in the trial. 7. Ability of the subject s parent or legally acceptable representative/guardian to understand and comply with the requirements of the protocol.
Exclusion criteria
Exclusion criteria: 1. Child in care 2. Prior immunization and co-administration of any OPV or IPV, DTP, Hepatitis-B or Hib vaccine with the exception of birth dose BCG, Hepatitis B and OPV. 3. Current illness (especially fever) or any acute or congenital illness or disability. 4. Evidence of previous or intercurrent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and/or H. influenzae type b diseases 5. Subjects receiving immunosuppressive therapy. 6. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). 7. Known or suspected allergy to any of the vaccine components. History of allergic disease or history of a serious reaction to any prior vaccination or known hypersensitivity likely to be exacerbated by any component of the study vaccines. 8. Any sign or symptom of systemic dysfunction, especially of the central nervous system (CNS). 9. Known family history of SIDS (Sudden Infant Death Syndrome). 10. Planned or elective surgery during the course of the study. 11. Infants who have received any blood products. 12. Subjects and / or their mothers who have participated / are participating in another clinical trial of an investigational agent within last 30 days or likely to participate during the study course. 13. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine during the period starting 30 days before the administration of study vaccine (Day -29 to Day 0), or planned use during the study period. 14. Inability or unwillingness to abide by the requirements of the protocol. 15. Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe. 16. Infant is a direct descendant (child or grand-child) of any person employed by the Sponsor, the Contract Research Organization (CRO) or the Study Site (including the PI and study site personnel). 17. Any criteria, which in the opinion of the Investigator, suggests that the subject would not be compliant with the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects sero-protected for anti-Diphtheria, anti-Tetanus, anti-PRP-T, anti-HBsAg, serotype-specific anti-Polio antibodies, and seroconverted for anti-PertussisTimepoint: At Day 84 (28 days post-third dose) | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with solicited local adverse reactions and systemic eventsTimepoint: during the first 30 minutes following vaccine administration after each dose;Proportion of subjects with solicited local and systemic adverse events (AEs)Timepoint: during the 7-day (Day 0-6) post vaccination period;Proportion of subjects with unsolicited adverse events (AEs)Timepoint: during the 28 day follow up period after each dose of vaccination;Proportion of subjects with occurrence, severity and causality of all the reported adverse eventsTimepoint: 28 days after each dose.;Rate of serious adverse events (SAEs) and medically attended AEsTimepoint: for the total study period.;Proportion of subjects with SAEsTimepoint: during the 6 months follow up period after the third dose of the vaccination;Geometric mean concentrations/titres (GMC/Ts) and GMFR for anti-Diphtheria, anti-Tetanus, anti-Pertussis, anti-HBsAg, anti-PRP and serotype specific anti-Polio antibody concentrations/titresTimepoint: Both at baseline and again at Day 84;Number and proportion of subjects seroconverted in terms of serum IgG concentrations induced by 14 serotypes of BE-PCV14 and serum IgA concentrations induced by Rotavirus vaccine in both BE s LHV and licensed comparator vaccinated subjects.Timepoint: At day 84;Geometric mean concentrations/titres for anti-diphtheria, anti-tetanus, anti-pertussis, anti-hepatitis B, anti-haemophilus influenzae type b and anti-polio serotypes 1, 2 & 3, estimated in all three lots of BE s LHVTimepoint: at baseline and again at Day 84 | — |
Countries
India
Contacts
Public ContactMr Subba Reddy GV
Biological E.Limited
Outcome results
None listed