NCT02904213

Evaluate Safety of ComBe Five (Liquid) in Healthy Vietnamese Children Aged From 8 - 10 Weeks as a 3-dose Series, Interval for Each Dose is 4 Weeks

A Bridging Study to Evaluate Safety of ComBe Five (Liquid) (Combined Pentavalent DTwP-rHepB-Hib Vaccine) Made in India, in Healthy Vietnamese Children Aged From 8 - 10 Weeks as a 3-dose Series, Interval for Each Dose is 4 Weeks

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 330 (actual)
• Sponsor: Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products · Academic / Other
• Sex: All
• Age: 8 Weeks – 10 Weeks
• Healthy volunteers: Accepted

Summary

An open label, non-comparative bridging study to evaluate the safety of pentavalent vaccine ComBe Five (Liquid) made in India, in healthy Vietnamese children aged from 8 - 10 weeks as a 3-dose series, interval for each dose is 4 weeks

Detailed description

The trial is a bridging Study to evaluate safety of pentavalent vaccine ComBe Five (Liquid) made in India, in healthy Vietnamese children aged from 8 - 10 weeks as a 3-dose series, interval for each dose is 4 weeks. 330 subjects will be enrolled in Binh Luc and Ly Nhan district, Ha Nam province. These subjects will be received 3 doses (0.5ml/dose) ComBe Five (Liquid), the first dose will be administered at 8-10 weeks of age. The frequency, rate and severity of immediate adverse events within 30 minutes after vaccination, solicited and unsolicited AE within 28 days after vaccination, the frequency and rate of SAE within 28 days after the first vaccination will be recorded as evidences for ComBeFive (Liquid) safety assessment. The subjects to be included from this trial would be representative of the population of Vietnam. The protocol has been reviewed and approved by Vietnam Military Medical University IRB and Vietnam Ministry of Health IEC and Vietnam Minister of Health.

Conditions

• Safety, Pentavalent Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	ComBe Five (Liquid)

Timeline

• Start date: 2016-09-16
• Primary completion: 2016-12-19
• Completion: 2017-06-24
• First posted: 2016-09-16
• Last updated: 2017-12-18

Locations

1 site across 1 country: Vietnam