Study of Quinvaxem for Vaccination Against Diphtheria, Pertussis, Tetanus, Hepatitis B and Diseases Caused by Haemophilus Influenzae Type B
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ClinicalTrials.gov Identifier: NCT01362517 |
Recruitment Status
:
Completed
First Posted
: May 30, 2011
Results First Posted
: June 24, 2013
Last Update Posted
: September 9, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diphtheria Pertussis Tetanus Hepatitis B Haemophilus Influenzae Infections | Biological: Quinvaxem | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 131 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | April 2010 |
Actual Primary Completion Date : | July 2010 |
Actual Study Completion Date : | April 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: Quinvaxem |
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 |
- 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)
- 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)
- 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

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Ages Eligible for Study: | 60 Days to 120 Days (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01362517
Vietnam | |
Pasteur Institute | |
Ho Chi Minh City, Vietnam |
Principal Investigator: | Tran Ngoc Huu, PhD, MD | Pasteur Institute of Ho Chi Minh City |
Responsible Party: | Crucell Holland BV |
ClinicalTrials.gov Identifier: | NCT01362517 History of Changes |
Other Study ID Numbers: |
QVX-V-C001 |
First Posted: | May 30, 2011 Key Record Dates |
Results First Posted: | June 24, 2013 |
Last Update Posted: | September 9, 2013 |
Last Verified: | August 2013 |
Keywords provided by Crucell Holland BV:
Vaccination Immunisation Virus Diphtheria Pertussis |
Tetanus Hepatitis B Haemophilus Influenzae Immunity |
Additional relevant MeSH terms:
Tetanus Tetany Hepatitis Hepatitis A Influenza, Human Hepatitis B Whooping Cough Diphtheria Haemophilus Infections Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections |
RNA Virus Infections Orthomyxoviridae Infections Respiratory Tract Infections Respiratory Tract Diseases Hepadnaviridae Infections DNA Virus Infections Bordetella Infections Gram-Negative Bacterial Infections Bacterial Infections Infection Clostridium Infections Gram-Positive Bacterial Infections Neuromuscular Manifestations Neurologic Manifestations Nervous System Diseases |