Clinical study to compare immune response and safety of DPT vaccine of Cadila Healthcare Ltd. with DPT vaccine of Serum Institute of India Ltd. in healthy children

Phase 2/3

Completed

• Conditions: Primary immunization against Diphtheria, Tetanus & Pertussis; Encounter for immunization,

• Registration Number: CTRI/2015/05/005768
• Lead Sponsor: Cadila Healthcare Ltd

Brief Summary

This is a randomized, single blind, parallel, active controlled, non-inferiority, multicentre clinical trial to evaluate and compare the immunogenicity and safety of DPT vaccine of M/s Cadila Healthcare Ltd. with DPT vaccine of M/s Serum Institute of India Ltd. in healthy infants. Blood samples will be collected pre-vaccination (day 0) & at 28 days after last vaccination (day 84) to determine anti-diphtheria, anti-tetanus and anti-pertussis antibody titres. The primary objective of this study is to demonstrate the non-inferiority of test vaccine to the reference vaccine for proportion of subjects with sero-protective levels of anti-diphtheria, anti-tetanus and anti-pertussis antibodies post-vaccination. The sero-protective cut-off titre for serum anti-diphtheria & anti-tetanus antibodies is 0.1 IU/ml. The sero-protective cut-off titre considered for serum anti-pertussis antibodies is 22 U/ml.  The safety of the vaccine will be assessed by recording the adverse events occurring during the entire course of the study.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-18
• Study Completion: 2016-02-27
• Last Update Posted: 2018-11-14

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 282

Inclusion Criteria

• Healthy infant of either gender between 6-8 weeks of age (i.e. 42 to 56 days of age, both days inclusive) at the time of enrollment 2.
• Subject born after a normal gestational period of 37-42 weeks with birth weight ≥ 2.5 Kg 3.
• Body weight ≥ 3.3 Kg at the time of enrollment 4.
• Subject in a good clinical condition as judged by the investigator based on medical history and physical examination 5.
• Written informed consent obtained from the subject’s parents or legally acceptable representative 6.
• Subject’s parents or legally acceptable representative literate enough to fill the diary card.

Exclusion Criteria

• Any vaccination before enrollment except vaccination with BCG vaccine, Hepatitis-B vaccine and oral polio vaccine 2.
• Past history of diphtheria, pertussis or tetanus 3.
• History of known or suspected allergy to any of the vaccine components 4.
• History of thrombocytopenia or any coagulation disorder, or subject on anticoagulation therapy 5.
• Subject with any clinically significant congenital disorder, immunodeficiency disorder and subject on any immunosuppressive or immunostimulant therapy 6.
• Subject with history of clinically significant systemic disorder especially neurological disorder 7.
• Known personal or maternal history of HIV, Hepatitis-B (HBsAg) or Hepatitis-C seropositivity 8.
• History of any acute illness within the past 1 week 9.
• Subject with febrile illness (axillary temperature ≥ 37.5 0C) at the time of enrollment 10.
• Planned or elective surgery during the course of the study 11.
• History of administration of blood, any blood containing product or immunoglobulins since birth 12.
• Participation of subject in any clinical trial since birth or participation of subject’s mother in any clinical trial within the past 30 days.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of subjects with sero-protective levels of anti-diphtheria, anti-tetanus and anti-pertussis antibodies at day 84	28 days following last vaccination (day 84

Secondary Outcome Measures

Name	Time	Method
Geometric mean titre of anti-diphtheria, anti-tetanus and anti-pertussis antibodies at baseline and at day 84	28 days following last vaccination (day 84)

Trial Locations

Locations (8)

Andhra Medical College & King George Hospital, Visakhapatnam; 🇮🇳 Visakhapatnam, ANDHRA PRADESH, India

Gandhi Hospital, Secunderabad; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

GMERS Medical College & Civil Hospital, Ahmedabad; 🇮🇳 Ahmadabad, GUJARAT, India

Hi-Tech Medical College and Hospital, Bhubaneswar; 🇮🇳 Khordha, ORISSA, India

Institute of Child Health, Kolkata; 🇮🇳 Kolkata, WEST BENGAL, India

Kalinga Institute of Medical Sciences, Bhubaneswar; 🇮🇳 Khordha, ORISSA, India

King George’s Medical University, Lucknow; 🇮🇳 Lucknow, UTTAR PRADESH, India

Lokmanya Tilak Municipal Medical College & General Hospital, Mumbai; 🇮🇳 Mumbai, MAHARASHTRA, India

Andhra Medical College & King George Hospital, Visakhapatnam

🇮🇳Visakhapatnam, ANDHRA PRADESH, India

Dr D Ramaganeshan

Principal investigator

09848337511

domathotirg@gmail.com