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Completed

NCT Number: NCT01362517

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

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

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Key information

Conditions

Diphtheria Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Bordetella Infections Clostridium Infections Communicable Diseases Corynebacterium Infections DNA Virus Infections Digestive System Diseases Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Haemophilus Infections Haemophilus Influenzae Infections Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Viral, Human Infections Liver Diseases Pasteurellaceae Infections Pertussis Respiratory Tract Diseases Respiratory Tract Infections Tetanus Virus Diseases Whooping Cough

Age range

60 day–120 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pasteur Institute

Ho Chi Minh City, Vietnam

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Primary outcomes

  1. Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component

    Time frame: at 5 months (equivalent to 1 month after the third vaccination)

    Assessment of the proportion of subjects who have seroconverted to each of the 5 vaccine components (D, T, P, HepB, Hib)

  2. Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component

    Time frame: 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 outcomes

  1. Safety: Adverse and Serious Adverse Events

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Crucell Holland BV

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
May 30, 2011
Registry last updated
Sep 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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