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

NCT02904213 | Completed

• 1 other identifier: VX.2016.03
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Safety, Pentavalent Vaccine

Keywords

vaccine; ComBe Five; Vietnam; pentavalent

Outcome Measures

Primary Outcomes (4)

• Frequency and rate of the adverse effects and severity of immediate adverse events (Local and General) within 30 minutes after vaccination.

  30 minutes after vaccination

• Frequency and rate of adverse effects and severity of solicited adverse events (Local and General) within 7 days after each vaccination

  For 7 days after each vaccination

• Frequency and rate of adverse effects and severity of unsolicited adverse events (Local and General) during 28 days after each vaccination

  For 28 days after each vaccination

• Frequency and rate of adverse effects and severity of Serious Adverse Events (Local and General) during 28 days after each vaccination

  For 28 days after each vaccination

Study Arms (1)

Pentavalent vaccine

EXPERIMENTAL

3 Dose, interval for each dose is 4 weeks. The first dose will be received at 8-10 weeks of age

Biological: ComBe Five (Liquid)

Interventions

ComBe Five (Liquid) BIOLOGICAL

Pentavalent vaccine

Eligibility Criteria

• Age: 8 Weeks - 10 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Subject must meet all criteria below to participate in study:
• Healthy children, both genders, age from 8 -12 weeks at screening visit and the first dose (visit 1)
• Weight ≥ 3.300 gram at Screening visit and receive the first dose
• Understand and follow the study
• Mother of children have serum negative for HIV, HBV and HCV on blood test results or antenatal tests report book.
• Children or mother don't participate in other clinical study scheduled during the study.
• Parent/ legal guardian can understand and have ability to follow protocol.
• Parent/ legal guardian voluntary write consent to participate in the study.
• Parent/ legal guardian of subject have ability to comply with the process of study.
• Parent/ legal guardian of subject who intends to remain in the area with the participant during the study period.

You may not qualify if:

• Subject have one of criteria below must not participate in study:
• Fever (temperature ≥37.5oC) or loses temperature (≤35.5 oC) or disease/ infection chronic
• Subjects who had received DPT
• Subjects who had received immunosuppressant therapy
• Subjects with a known or doubt hypersensitivity of allergic reaction to any component of the study vaccine
• Subjects who had any signs or symptoms of functional disorder, especially central nervous system.
• Subjects who had haemophilia or received treatment anticoagulant drug, had a risk of serious bleeding when intramuscular injection.
• Subjects who had a family history of SIDS (Sudden Infant death syndrome)
• Subjects intend to surgery scheduled during the study
• Subjects who had received any blood products, corticosteroid cytotoxic drugs, radiotherapy.
• Subjects and mother who had participated in other clinical trial within 30 days priors to vaccination with study drug, or those who had another clinical trial scheduled during the study.
• Can't afford or not ready follow protocol
• Any criteria that, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence

Sponsors & Collaborators

• Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products: lead
• Biological E. Limited: collaborator

Study Sites (1)

Ha Nam Health Center

Hà Nam, 400000, Vietnam

Location

MeSH Terms

Interventions

Fluid Therapy

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 8, 2016
• First Posted: September 16, 2016
• Study Start: September 16, 2016
• Primary Completion: December 19, 2016
• Study Completion: June 24, 2017
• Last Updated: December 18, 2017

Record last verified: 2017-12

Locations

VN (1)