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.
- Conditions
- Primary immunization of healthy infants at 6, 10 and 14 weeks of age against diphtheria, tetanus and pertussis diseases
- Registration Number
- CTRI/2012/03/002490
- Lead Sponsor
- Prosper Channel Life Science India Pvt Ltd
- Brief Summary
This study is multricentric phase III clinical trial to assess the immunogenicity and reactogenicity of ’Diphtheria, Tetanus and acellular Pertussis combined vaccine Adsorbed’ administered to healthy infants at 6, 10 and 14 weeks of age that will be conducted at 2 centers in India. Primary outcome measures will be assessment of immunogenicity 1 month after the three dose primary vaccination series. The secondary outcome will be occurrence of solicitated and unsolicitated local and general adverse events during the 4 day follow up period after vaccination, during follow up and during entire study period.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- 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 Anti-PT, anti-FHA, anti-diphtheria and anti-tetanus antibody concentrations. one month after a three-dose primary vaccination course. Seroprotection status defined as anti-diphtheria and anti-tetanus antibody concentrations ≥ 0.1 IU/ml. one month after a three-dose primary vaccination course. Seroprotection defined for pertussis will be anti-PT, anti-FHA concentrations ≥ 5 EL.U/ml. one month after a three-dose primary vaccination course.
- Secondary Outcome Measures
Name Time Method Occurrence of solicited local adverse events Occurrence of solicited general adverse events During the 4-day (Days 0, 1, 2, 3) follow up period after vaccination Occurrence of unsolicited local and general adverse events On follow up Occurrence of serious adverse events During entire study
Trial Locations
- Locations (2)
Department of Pediatrics Maulana Azad Medical College & LNJP Hospital Delhi
🇮🇳Central, DELHI, India
Department of Pediatrics University College of Medical Sciences & GTB Hospital Delhi
🇮🇳East, DELHI, India
Department of Pediatrics Maulana Azad Medical College & LNJP Hospital Delhi🇮🇳Central, DELHI, IndiaDr AP DubeyPrincipal investigator9968604303apdubey52@rediffmail.com