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

Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01362517
• Other study ID #: QVX-V-C001
• Status: Completed
• Phase: Phase 3
• First received: May 26, 2011
• Last updated: August 29, 2013
• Start date: April 2010
• Est. completion date: April 2011

Study information

• Verified date: August 2013
• Source: Crucell Holland BV
• Contact: n/a
• Is FDA regulated: No
• Health authority: Vietnam: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: April 2011
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Days to 120 Days

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diphtheria
• Haemophilus Infections
• Haemophilus Influenzae Infections
• Hepatitis
• Hepatitis A
• Hepatitis B
• Influenza, Human
• Pertussis
• Tetanus
• Whooping Cough

Intervention

Biological:
• Quinvaxem
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

Locations

Country	Name	City	State
Vietnam	Pasteur Institute	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
Crucell Holland BV

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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	No
Secondary	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	Yes