A clinical trial to assess the efficacy and safety of ?Diphtheria, Tetanus and Acellular Pertussis Combined Vaccine, Adsorbed? administered to healthy infants at 6, 10 and 14 weeks of age.
- Registration Number
- CTRI/2012/03/002490
- Lead Sponsor
- Prosper Channel Life Science India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 125
Healthy infants of 6(+4) weeks of age whose parents/legal guardians give written informed consent prior to the study entry.
Infants not seroprotected by immunization and/or disease (to any of the agents targeted by the DPT/DTPa vaccine)
Evolving or changing neurological disorder
History of seizures
Fever 38°C in past 3 days
Acute illness or infection requiring systemic antibiotic therapywithin past 7 days
Previous disease potentially related to any of the agents targeted by the DPT vaccine
Preterms
Impairment of the immune function, or
receiving or having received immunosuppressive
therapy within 1 month prior to study entry till completion
Received any blood or blood products, cytotoxic agents or radiotherapy
History of anaphylaxis, or any serious vaccine reaction, or allergy to any vaccine component
Chronic disease such as cardiac, autoimmune disease or with any condition that in the opinion of the investigator might interfere with the evaluation of the study objectives.
Participated in another trial of an investigational agent within 30 days of enrolment
Infants whose families are planning to leave the area of the study site before the end of the study period.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method