Post Marketing Surveillance study (PMS) of Tetanus Vaccine (Adsorbed) I.P. in (0.5ml) single dose ampoule/ Ten doses (5ml vial) administered to children, adolescents and adults in either gender including pregnant women

Multicentre, Post Marketing Surveillance study (PMS) to generate the safety data of Tetanus Vaccine (Adsorbed) I.P. in (0.5ml) single dose ampoule/ Ten doses (5ml vial) administered to children, adolescents and adults in either gender including pregnant women - Dano TT PMS

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2016/03/006729

Enrollment

500

Registered

2016-03-14

Start date

Unknown

Completion date

Unknown

Last updated

2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Tetanus Vaccine: 0.5ml dose intramuscular administration Intervention2: Nil: Nil Control Intervention1: NOT APPLICABLE: NOT APPLICABLE

Eligibility

Inclusion criteria

Inclusion criteria: • Children, and adults in either gender including pregnant women aged 5 to 50 years of age (inclusive) who provide voluntary written informed consent by subject or its legal representatives. Adolescents (12 to 17 years of age) provision of assent form signed by the subject and informed consent form signed by the parent (s) or legal representative • Subject where Tetanus Vaccine (Adsorbed) I.P. is indicated • Subjects willing to comply with protocol procedures • Good clinical condition established by medical history and physical examination (with no acute disease, infection or high temperature >39.50 C, history of allergic disease or persistent hematological, hepatic, renal, cardiac or respiratory disease and signs of a CNS disorder at the time of vaccination)

Exclusion criteria

Exclusion criteria: • Participation in another clinical trial in the 4 weeks preceding the trial inclusion or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy since birth; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks since birth) • Previous evidence of Tetanus • History of allergic disease or reaction likely to be exacerbated by any component of the vaccine including allergy to antibiotics • Subjects who had prior seizures, whether febrile or afebrile

Design outcomes

Primary

Measure	Time frame
Safety To generate the long term safety data of Tetanus vaccine (Adsorbed) I.P. (M/S Dano Vaccines & Biologicals Private Limited) in Indian subjects Timepoint: â?¢Percentage and number of subjects experiencing local and/ or systemic reactions within 7 days after vaccination â?¢Number of serious adverse events occurring during follow up period	—

Secondary

Measure	Time frame
NilTimepoint: Nil	—

Countries

India

Contacts

Public ContactD Srinivasa Raju

AbiogenesisClinpharm Private Limited

pawanbhusari@abiogenesisclinpharm.com914046464841

Outcome results