DiphtheriaPhase 3NCT01362517

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

A Phase 3 study testing Quinvaxem in people with Diphtheria and Pertussis, run by Crucell Holland BV at 1 site in Vietnam.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 60 to 120 daysHealthy volunteers can take part
Conditions the study is for: Diphtheria, Pertussis, Tetanus
What is being tested?: Quinvaxem
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 131 participants
Where: 1 siteVietnam
Study dates: Apr 2010to Apr 2011
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 to 120 days
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

Vietnam1 site

Pasteur Institute
Ho Chi Minh City

Other trials in Vietnam

About this study

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

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
Being tested: Quinvaxem
Keywords: Vaccination, Immunisation, Virus, Diphtheria, Pertussis, Tetanus, Hepatitis B, Haemophilus Influenzae, Immunity
Medical subject headings: Diphtheria, Whooping Cough, Tetanus, Hepatitis B, Haemophilus Infections, Virus Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

QuinvaxemBiological
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

Study groups in NCT01362517
Study group	Role	What they receive
Quinvaxem	Experimental	Not described Receives: Biological: Quinvaxem

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 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)
Measured: at 14 months (equivalent to 12 months after the first vaccination

Secondary outcomes (1)

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
Measured: From Day 1 up to 30 days after the third vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2010Apr 2011

First posted30 May 2011 (estimated)
Study startApr 2010
Primary completionJul 2010
Study completionApr 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for DiphtheriaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 131 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01362517
Sponsor's protocol ID: QVX-V-C001
Status last verified: Aug 2013
First submitted: 26 May 2011
Last updated: 9 Sep 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
A Phase II Clinical Trial of Absorbed Acellular Pertussis (Two-Component) Diphtheria-Tetanus Combined Vaccine (For Adults and Adolescents)
Pertussis (Whooping Cough), Diphtheria
RecruitingPhase 1/2
A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
Diphtheria, Pertussis
RecruitingPhase 4
Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy
RSV, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination
Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization
Active, not recruitingPhase 3
A Study on the Immune Response and Safety of a Combined Vaccine Against Diphtheria, Tetanus and Acellular Pertussis (dTpa) in Japanese Healthy Pregnant Women
Diphtheria-Tetanus-acellular Pertussis Vaccines

All Diphtheria trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01362517
Acronym / sponsor ID: QVX-V-C001
Conditions: Diphtheria, Pertussis, Tetanus, Hepatitis B, Haemophilus Influenzae Infections
Keywords: Vaccination, Immunisation, Virus, Diphtheria, Pertussis, Tetanus, Hepatitis B, Haemophilus Influenzae
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 131 participants (actual)
Lead sponsor: Crucell Holland BVIndustry (pharma, biotech, devices)
Study start: Apr 2010
Primary completion: Jul 2010 (actual)
Study completion: Apr 2011 (actual)
First posted: 30 May 2011 (estimated)
Results: Posted 24 Jun 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Quinvaxem	Experimental	Biological: Quinvaxem

Who may qualify

Ages: 60 to 120 days
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (6 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
QuinvaxemA 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	Biological	Quinvaxem

Primary outcome

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)

1 secondary outcome

Safety: Adverse and Serious Adverse Events
Time frame: From Day 1 up to 30 days after the third vaccination

Results and safety

Results posted to the registry on 24 Jun 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Quinvaxem	131	129

Primary outcome: Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component

Time frame: at 5 months (equivalent to 1 month after the third vaccination). Number (95% Confidence Interval). Unit: percentage of subjects

Measure	Quinvaxem n = 130
% of subjects with anti-diphtheria >=0.1 IU/mL	93.1 (87.3 to 96.8)
% of subjects with anti-pertussis >=20 EU/mL	99.2 (95.8 to 100)
% of subjects with anti-tetanus >=0.1 IU/mL	98.5 (94.6 to 99.8)
% of subjects with anti-hepatitis B >=10 mIU/mL	93.1 (87.3 to 96.8)
% of subjects with anti-PRP>=0.15 mcg/mL	100 (97.2 to 100)

Population analysed: Analysis population excludes one subject excluded as a protocol violator

Primary outcome: Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component

Time frame: at 14 months (equivalent to 12 months after the first vaccination. Number (95% Confidence Interval). Unit: percentage of subjects

Measure	Quinvaxem n = 129
% of subjects with anti-diphtheria >=0.1 IU/mL	88.4 (81.5 to 93.3)
% of subjects with anti-pertussis >=20 EU/mL	49.6 (40.7 to 58.5)
% of subjects with anti-tetanus >=0.1 IU/mL	82.2 (74.5 to 88.3)
% of subjects with anti-hepatitis B >=10 mIU/mL	76.7 (68.5 to 83.7)
% of subjects with anti-PRP >=0.15 mcg/mL	97.7 (93.4 to 99.5)

Population analysed: Analysis population excludes one subject excluded as a protocol violator and additionally at 14 months one lost to follow up

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Parents of subjects recorded solicited local and systemic and unsolicited adverse events from baseline up to 28 days after vaccination.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
First Dose	4 of 131 (3.1%)	75 of 131 (57.3%)	Not reported
Second Dose	6 of 131 (4.6%)	34 of 131 (26%)	Not reported
Third Dose	1 of 130 (0.8%)	25 of 130 (19.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Diphtheria

RecruitingPhase 2
A Phase II Clinical Trial of Absorbed Acellular Pertussis (Two-Component) Diphtheria-Tetanus Combined Vaccine (For Adults and Adolescents)
Pertussis (Whooping Cough), Diphtheria
RecruitingPhase 1/2
A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
Diphtheria, Pertussis
RecruitingPhase 4
Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy
RSV, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination
Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization
Active, not recruitingPhase 3
A Study on the Immune Response and Safety of a Combined Vaccine Against Diphtheria, Tetanus and Acellular Pertussis (dTpa) in Japanese Healthy Pregnant Women
Diphtheria-Tetanus-acellular Pertussis Vaccines

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tran Ngoc Huu, PhD, MD principal investigator

Pasteur Institute of Ho Chi Minh City

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Quinvaxem in people with Diphtheria and Pertussis, run by Crucell Holland BV at 1 site in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component (time frame: at 5 months (equivalent to 1 month after the third vaccination)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01362517.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2013.