Completed
Assessment of the Immunogenicity and Safety of Quinvaxem Vaccine (DTwP-HepB-Hib) Against Diphtheria, Pertussis, Tetanus, Hepatitis B and Diseases Caused by H. Influenzae Among Healthy Vietnamese Children
What is being tested
Quinvaxem
Biological
Who is being recruted
Blood-Borne Infections+23
+ Actinomycetales Infections
+ Bacterial Infections and Mycoses
+13 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 3
Interventional
Study Start: April 2010
Summary
Principal SponsorCrucell Holland BV
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 2010
Actual date on which the first participant was enrolled.The aim of this study was to evaluate the immunogenicity and safety of the Quinvaxem vaccine (a liquid combination vaccine against diphtheria, tetanus, B. pertussis, hepatitis B and H. influenzae Type B). Healthy Vietnamese infants received three doses of vaccine at 2, 3 and 4 months of age according to the local Expanded Programme on Immunisation (EPI) schedule
Official TitleAssessment of the Immunogenicity and Safety of Quinvaxem Vaccine (DTwP-HepB-Hib) Against Diphtheria, Pertussis, Tetanus, Hepatitis B and Diseases Caused by H. Influenzae Among Healthy Vietnamese Children
Principal SponsorCrucell Holland BV
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
131 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Range of ages for which participants are eligible to join.
Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Blood-Borne InfectionsActinomycetales InfectionsBacterial Infections and MycosesBacterial InfectionsBordetella InfectionsClostridium InfectionsCommunicable DiseasesCorynebacterium InfectionsDigestive System DiseasesDiphtheriaDNA Virus InfectionsHaemophilus InfectionsHepatitisHepatitis BHepatitis, Viral, HumanInfectionsLiver DiseasesRespiratory Tract DiseasesRespiratory Tract InfectionsTetanusVirus DiseasesWhooping CoughPasteurellaceae InfectionsGram-Negative Bacterial InfectionsGram-Positive Bacterial InfectionsHepadnaviridae Infections
Criteria
6 inclusion criteria required to participate
Infants are at age of DTP vaccination of the local EPI program (60-120 days old) and free from any obvious health problems
Have a normal gestational age (≥ 37 weeks); birth weight > 2.5 kg
There is no congenital disease detected through interview and clinical examination
Already had or not yet received Hepatitis B vaccination at birth
Show More Criteria
7 exclusion criteria prevent from participating
Already vaccinated with DTP vaccine
Have an acute infection at the time of study vaccination
Contraindications to Quinvaxem
Receiving treatment with systemic corticosteroids
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Suspended
CompletedOne Study Center