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.

A multicentric, 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.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/03/002490

Enrollment

125

Registered

2012-03-13

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Diphtheria, Tetanus and Acellular Pertussis Combined Vaccine: 0.5 ml per dose by deep intramuscular injection to healthy Infants at 6, 10 and 14 weeks of age Control Intervention1: None

Eligibility

Inclusion criteria

Inclusion criteria: 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)

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Anti-PT, anti-FHA, anti-diphtheria and anti-tetanus antibody concentrations. Seroprotection status defined as anti-diphtheria and anti-tetanus antibody concentrations â?¥ 0.1 IU/ml. Seroprotection defined for pertussis will be anti-PT, anti-FHA concentrations â?¥ 5 EL.U/ml. Timepoint: one month after a three-dose primary vaccination course.	—

Secondary

Measure	Time frame
Occurrence of serious adverse eventsTimepoint: During entire study;Occurrence of solicited general adverse eventsTimepoint: During the 4-day (Days 0, 1, 2, 3) follow up period after vaccination;Occurrence of solicited local adverse events Timepoint: During the 4-day (Days 0, 1, 2, 3) follow up period after vaccination ;Occurrence of unsolicited local and general adverse eventsTimepoint: On follow up	—

Measure

Time frame

Occurrence of serious adverse eventsTimepoint: During entire study;Occurrence of solicited general adverse eventsTimepoint: During the 4-day (Days 0, 1, 2, 3) follow up period after vaccination;Occurrence of solicited local adverse events Timepoint: During the 4-day (Days 0, 1, 2, 3) follow up period after vaccination ;Occurrence of unsolicited local and general adverse eventsTimepoint: On follow up

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Countries

India

Contacts

Public ContactRajeev Kumar Pathak

Prosper Channel Life Science India Pvt. Ltd.

rrajivpathak@gmail.com01125089029

Outcome results