Phase III clinical study to evaluate the effectivity of Comvac4 vaccine in 6 to 7weeks infants

A Phase-III multicentric randomized open label, active Controlled study to evaluate the Immunogenicity and Safety of BBILs combination of DTwPHib (Comvac4) vaccine in comparison with Reference Vaccine Comvac3â?¢ BioHib in healthy infants of 6 to 7 weeks age - Comvac4

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/01/007706

Enrollment

200

Registered

2017-01-16

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: Comvac4 (DTwP-Hib) vaccine: Comvac4 is a tetravalent vaccine. It is available in liquid PFS. Subjects will be administered on day0, day28, day56. Vaccine will be administered through in

Eligibility

Inclusion criteria

Inclusion criteria: 1.Parent/guardian of subject willing to give written informed consent and to comply with all study related procedures and visits 2.Healthy male or female infants aged 6 â?? 7 weeks at the time of screening/enrolment. 3.Subjects who are healthy without any history of DTP and Hib vaccination 4.Infants received EPI vaccines at birth (i.e., OPV, BCG and/or Hep B) as well IPV 5.Subjects should have been born after 36-week term and are not less than >=4.00kg, at the time of inclusion

Exclusion criteria

Exclusion criteria: 1.Infants aged less than 6 weeks or more than 7 weeks at the time of screening/enrolment. 2.Fever of any origin of duration more than 3 days prior to/at screening visit. 3.Past history of DTP &Hib vaccination. 4.History of acute or chronic auto immune disease 5.Any confirmed or suspected immunosuppressive condition. 6.Any treatment with immunosuppressive or immunostimulant therapy 7.Use of any marketed or investigational or herbal medicine or non-registered drug or vaccine for DTP and Hib. 8.Known hypersensitivity reactions to any of the components of the vaccine. 9.Any criteria, which in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol

Design outcomes

Primary

Measure	Time frame
To compare the pre vaccination anti diphtheria1 antitetanus antipertussis, and anti Hib (PRP) verses 4weeks titer of after third dose. Seroprotection Attainment of antibody titers that corresponds to clinical protection. This is according to WHO established level of titers. â?¢ Seroconversion:Seroconversion will be considered if the 4 weeks after third dose post-vaccination antibody titer shows a â?¥ 4 fold rise from the pre-vaccination levels Timepoint: 0 and 84	—

Measure

Time frame

To compare the pre vaccination anti diphtheria1 antitetanus antipertussis, and anti Hib (PRP) verses 4weeks titer of after third dose. Seroprotection Attainment of antibody titers that corresponds to clinical protection. This is according to WHO established level of titers. â?¢ Seroconversion:Seroconversion will be considered if the 4 weeks after third dose post-vaccination antibody titer shows a â?¥ 4 fold rise from the pre-vaccination levels Timepoint: 0 and 84

—

Secondary

Measure	Time frame
To evaluate the safetyTimepoint: During the study period and 7days active follow up after each vaccination	—

Countries

India

Contacts

Public ContactDr V Krishna Mohan

Bharat Biotech International Ltd.

kmohan@bharatbiotech.com04023480567

Outcome results