A Phase IV Clinical Study to Evaluate the Safety and Efficacy of ComVac5 (DTwP-Hep-B-Hib, Liquid Pentavalent vaccine of Bharat Biotech)

Phase 4

Completed

• Conditions: Prevention of Diphtheria, Tetanus, Pertussis, Hepatitis B and Haemophilus influenzae type b (Hib)

• Registration Number: CTRI/2010/091/001128
• Lead Sponsor: Bharat Biotech International Limited

Brief Summary

The study will be a phase IV, multicentric randomized, controlled , open label, non-inferiority trial to assess safety and immunogenicity of the study vaccine versus the reference vaccine in healthy Indian children. A total of 300 needs to be vaccinated - 225 in the test arm and 75 in the control arm at the ratio of 3:1.The multicentric study will be at carried out at various centers in India. Primary Objective is to compare and demonstrate that the Immunogenicity and safety of the investigational product ComVac-5, is not clinically inferior to that of the WHO Pre-Qualified Reference Vaccine, in healthy subjects. Secondary Objective is Assessment of Safety:  The safety of the vaccine in the study population will be evaluated by estimation of incidence of both serious and non-serious adverse events ( local and systemic reactions) 4 weeks post vaccination with an intensive initial monitoring phase of 30 minutes post vaccination. Monitoring of safety would include all solicited and unsolicited AE and Vaccine consistency: To demonstrate lot to lot consistency between three different batches of the test vaccine.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-21
• Last Update Posted: 2013-08-03

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• 1)Parent/guardian of subject willing to give written informed consent and to comply to all study related procedures and visits.
• 2)Healthy male or female infant aged 6 to 8 weeks at the time of screening/enrollment.
• 3)Subjects who are healthy without any history of DTP and Hib vaccination.
• (As Hepatitis B vaccination is often done at birth, history of immunization against Hepatitis B at birth is not a parameter for exclusion but the fact is recorded in the case record form).
• 4)Infant who is HBsAg negative.
• 5)Subjects should have been born after 36-week term and are not less than 3200 gms, at the time of inclusion.

Exclusion Criteria

• 1)Fever of any origin of duration more than 3 days prior to/at screening visit.
• 2)Past history of DTP & Hib vaccination.
• 3)History of acute or chronic auto immune disease.
• 4)Any confirmed or suspected immunosuppressive condition.
• 5)Any treatment with immunosuppressive or immuno stimulant therapy 6)Use of any marketed or investigational or herbal medicine or non-registered drug or vaccine for DTP Hepatitis B and Hib.
• 7)Any criteria, which in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol.
• 8)Known hypersensivity reactions to any of the components of the vaccine.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the safety and immunogenicity of ComVac-5 (DTwP-Hep-B-Hib, Liquid Pentavalent vaccine of BBIL) Versus reference WHO Pre-Qualified vaccine, in healthy subjects of age 6-8 weeks at time of enrollment as a non-inferiority trial.	3 months
Immunogenicity	3 months
Seroconversion	3 months
Seroprotection	3 months

Secondary Outcome Measures

Name	Time	Method
1. Safety: monitoring of all local and systemic Adverse Events (solicited and unsolicited) following vaccination throughout the study period of 3 months.	2. To demonstrate lot to lot consistency between three different batch of test vaccine

Trial Locations

Locations (3)

1. King George Hospital; 🇮🇳 Hospital,, India

Gandhi Hospital; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Mysore Medical College & Research Center; 🇮🇳 Mysore, KARNATAKA, India

1. King George Hospital

🇮🇳Hospital,, India

Dr. P. Venu Gopal

Principal investigator

venugopal_kgh@yahoo.com