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

Phase 3

Completed

• Conditions: Pertussis; Tetanus; Diphtheria; Hepatitis B; Haemophilus Influenzae Infections
• Interventions: Biological: Quinvaxem

• Registration Number: NCT01362517
• Lead Sponsor: Crucell Holland BV

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Primary Completion: 2010-07
• Study Completion: 2011-04
• Study First Submitted: 2011-05-26
• Study First Submitted QC: 2011-05-27
• Study First Posted: 2011-05-30
• Results First Submitted: 2013-03-27
• Results First Submitted QC: 2013-05-15
• Results First Posted: 2013-06-24
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-29
• Last Update Posted: 2013-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Quinvaxem	Quinvaxem	-

Primary Outcome Measures

Name	Time	Method
Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component	at 14 months (equivalent to 12 months after the first vaccination	Assessment of the proportion of subjects who have seroconverted to each of the 5 vaccine components (D, T, P, HepB, Hib)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Pasteur Institute; 🇻🇳 Ho Chi Minh City, Vietnam