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

NCT01362517 | Completed Phase 3 Results

• 1 other identifier: QVX-V-C001
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

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

Conditions

Diphtheria; Pertussis; Tetanus; Hepatitis B; Haemophilus Influenzae Infections

Keywords

Vaccination; Immunisation; Virus; Diphtheria; Pertussis; Tetanus; Hepatitis B; Haemophilus Influenzae; Immunity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Safety: Adverse and Serious Adverse Events

  From Day 1 up to 30 days after the third vaccination

Study Arms (1)

Quinvaxem

EXPERIMENTAL

Biological: Quinvaxem

Interventions

Quinvaxem BIOLOGICAL

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

Quinvaxem

Eligibility Criteria

• Age: 60 Days - 120 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Crucell Holland BV: lead

Study Sites (1)

Pasteur Institute

Ho Chi Minh City, Vietnam

Location

MeSH Terms

Conditions

Diphtheria; Whooping Cough; Tetanus; Hepatitis B; Haemophilus Infections; Virus Diseases

Condition Hierarchy (Ancestors)

Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Bordetella Infections; Gram-Negative Bacterial Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Clostridium Infections; Blood-Borne Infections; Communicable Diseases; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Pasteurellaceae Infections

Results Point of Contact

• Title: Medical Affairs Director
• Organization: Crucell Switzerland AG

info@crucell.com

+41(0)319806111

Study Officials

• Tran Ngoc Huu, PhD, MD

  Pasteur Institute of Ho Chi Minh City

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2011
• First Posted: May 30, 2011
• Study Start: April 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: April 1, 2011
• Last Updated: September 9, 2013
• Results First Posted: June 24, 2013

Record last verified: 2013-08

Locations

VN (1)