Study of Quinvaxem for Vaccination Against Diphtheria, Pertussis, Tetanus, Hepatitis B and Diseases Caused by Haemophilus Influenzae Type B

Study Overview
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Brief Summary
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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 Title
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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

Conditions
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Diphtheria, Pertussis, Tetanus, Hepatitis B, Haemophilus Influenzae Infections

Intervention / Treatment
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* Biological: Quinvaxem


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Do not have dermatological diseases such as eczema, allergies Parent or legal guardian voluntarily provides consent for their child for participation in the study by signing the informed consent and agrees to comply with all study procedures Exclusion Criteria: Already vaccinated with DTP vaccine Have an acute infection at the time of study vaccination Contraindications to Quinvaxem Receiving treatment with systemic corticosteroids Currently participating in another clinical trial In receipt of a parenteral immunoglobulin preparation and/or blood/blood products since birth Parents intend to move to another location during the study (the next 12 months)

Ages Eligible for Study
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Minimum Age: 60 Days
Maximum Age: 120 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Quinvaxem<br> | Biological: Quinvaxem<br>* A single dose (0.5 mL) of Quinvaxem contains: diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), whole-cell inactive pertussis bacteria (>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen One dose of Quinvaxem given at 2, 3 and 4 months of age<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component | Assessment of the proportion of subjects who have seroconverted to each of the 5 vaccine components (D, T, P, HepB, Hib) | at 5 months (equivalent to 1 month after the third vaccination) | 
| Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component | Assessment of the proportion of subjects who have seroconverted to each of the 5 vaccine components (D, T, P, HepB, Hib) | at 14 months (equivalent to 12 months after the first vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Adverse and Serious Adverse Events | Assessment of the proportion of children with adverse events and/or serious adverse events following each Quinvaxem vaccine injection | From Day 1 up to 30 days after the third vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaccination, Immunisation, Virus, Diphtheria, Pertussis, Tetanus, Hepatitis B, Haemophilus Influenzae, Immunity