Health Condition 1: Z23- Encounter for immunization
Conditions
Interventions
Intervention1: Tdap vaccine by SIIPL: 0.5 ml intramuscular, single dose
Control Intervention1: BOOSTRIX�® vaccine of GSK: 0.5 ml intramuscular, single dose
Sponsors
Serum Institute of India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1 Healthy male or female subjects aged 4 years to 65 years on the day of enrollment 2 Healthy subjects as established by medical history, physical examination during screening and as per the clinical judgment of the Investigator 3 Sexually active participants to be using an effective method of contraception 30 days prior to the enrollment and throughout the study period 4 Subjects/ parent willing to provide assent or written informed consent 5 Subjects/ parent willingness and ability to comply with the requirements of the protocol
Exclusion criteria
Exclusion criteria: 1.History of previous vaccination against diphtheria, tetanus and pertussis with either the trial vaccine or another vaccine (except Tetanus-prone wound management for adults and/or for tetanus vaccination in pregnant women) in the past 5 yrs. 2.History of Tetanus, diphtheria or pertussis infection 3.History of administration of any vaccine within 30 days prior to administration of study vaccine or planned during the course of study participation. 4.History of a serious reaction to any prior vaccination or known hypersensitivity to any component of the study vaccines. 5.History of anaphylactic shock. 6.History of any major pulmonary, cardiovascular, renal, neurological, metabolic, gastro-intestinal, hepato-biliary, hematological functional abnormality, mental or physical disability or blood dyscrasias. 7.History of encephalopathy of unknown aetiology occurring within 7 days following a previous vaccination with a vaccine containing a pertussis component. 8.History of neurological complications following an earlier vaccination against diphtheria and/or tetanus. 9.Acute illness and/or fever at the time of vaccination or during the 7 days prior to the vaccination. 10.Receipt of any oral or injectable antibiotics 5 days before enrollment. 11.History of any cancer, HIV infection, organ transplant or any other immune system disorder. 12.Chronic administration of immunosuppressant or other immune modifying drugs during the period starting six months prior to the study vaccine dose. 13.History of receipt of a blood transfusion, other blood products, or immunoglobulins in 3 months prior to study vaccination. 14.Females who are pregnant, breastfeeding or planning to become pregnant. 15. 15.Participant has any plans to permanently relocate from the area prior to the completion of the study or to leave for an extended period of time when study visits would need to be scheduled.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Percentage of subjects achieving the booster responses to diptheria toxoid 30 days after vaccination with Tdap and Boostrix 2)Percentage of subjects achieving the booster responses to tetanus toxoid 30 days after vaccination with Tdap and Boostrix 3)Percentage of subjects achieving booster response for PT, FHA and PRN 30 days after vaccination with Tdap and Boostrix 4)Anti-PT, anti-FHA and antiPRN antibody GMCs 30 days after vaccination with Tdap and Boostrix Timepoint: One month after the vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Percentage of subjects with seroprotection against Diphteria and Tetanus 30 days after vaccination 2)Percentage of seropositive subjects against Pertussis antigens 30 days after vaccination 3)Antibody geometric mean concentrations for anti-diphtheria, anti-tetanus 30 days after vaccination in both the groups 4)Frequency of adverse event that occurred during the 30 days follow-up period after vaccination. Timepoint: One month after the vaccination | — |
Countries
India
Contacts
Public ContactDr Hitt Sharma
Serum Institute of India Pvt. Ltd.
Outcome results
None listed