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VaricellaPhase 3NCT00432042

Immunogenicity and Safety Study of Proquad® and Infanrix® Hexa When Administered Concomitantly (V221-035)

A Phase 3 study testing ProQuad® and Infanrix® hexa in people with Varicella and Measles, run by Merck Sharp & Dohme LLC at 50 sites in 2 countries.

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

Primary Objective: To demonstrate that ProQuad® can be administered concomitantly with a booster dose of Infanrix® hexa to healthy children 12 to 23 months of age without impairing either the antibody response rates to measles, mumps, rubella, varicella, hepatitis B and Haemophilus influenzae type b; or to the 3… Read more about this study

Who is it for?
Ages 12 to 23 monthsHealthy volunteers can take part
Conditions the study is for
Varicella, Measles, Mumps
What is being tested?
ProQuad® and Infanrix® hexa
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
955 participants
Where
50 sitesin 2 countries
Study dates
12 Jan 2007to 27 Mar 2008
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 12 to 23 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Healthy participants of either gender
  • Aged 12 to 23 months
  • No clinical history of measles, mumps, rubella, varicella and zoster
  • For Italy: Primary vaccination with the combined diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b vaccine Infanrix® hexa as a 2-dose schedule, with receipt of the second dose ≥ 6 months prior to inclusion
  • For Germany: Primary vaccination with the combined diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b vaccine Infanrix® hexa as a 3-dose schedule, with receipt of the third dose ≥ 6 months prior to inclusion
  • Consent form signed by parent(s) according to local regulations or by the legal representative properly informed about the study
  • Parent(s)/legal representative able to understand the protocol requirements and to fill in the Diary Card.

Who cannot join

  • Prior receipt of measles, mumps, rubella and/or varicella vaccine either alone or in any combination
  • Any recent (<= 30 days) exposure to measles, mumps, rubella, varicella and/or zoster
  • Receipt of any other diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and/or Haemophilus influenzae type b containing vaccine (either alone or in any combination) than Infanrix® hexa
  • Any recent (<= 3 days) history of febrile illness
  • Any severe chronic disease
  • Active untreated tuberculosis
Show all 16Show fewer
  • Known personal history of encephalopathy, seizure disorder or progressive, evolving or unstable neurological condition
  • Any known blood dyscrasia, leukemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic or lymphatic systems
  • Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection
  • Prior known sensitivity/allergy to any component of the vaccines including neomycin, sorbitol or gelatin
  • Any immune impairment or humoral/cellular deficiency, neoplastic disease or depressed immunity
  • Any recent (<= 2 days) tuberculin test or scheduled tuberculin test through Visit 2
  • Any previous (<= 150 days) receipt of immune serum globulin or any blood-derived products or scheduled to be administered through Visit 2
  • Any recent (<= 30 days) receipt of an inactivated or a live non-study vaccine or scheduled non-study vaccination through Visit 2
  • Any medical condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives
  • Any recent (≤30 days) participation or scheduled participation in any other clinical trial through Visit 2

Trial locations and contacts

50 sites in 2 countries.

50 sites in 2 countries

Germany44 sites

  • Study site

    Alsfeld

  • Study site

    Bad Säckingen

  • Study site

    Bad Saulgau

  • Study site

    Bad Sobernheim

  • Study site

    Berlin

  • Study site

    Bielefeld

  • Study site

    Birkenfeld

  • Study site

    Bramsche

  • Study site

    Bretten

  • Study site

    Brunsbüttel

  • Study site

    Datteln

  • Study site

    Detmold

  • Study site

    Espelkamp

  • Study site

    Ettenheim

  • Study site

    Friedrichshafen

  • Study site

    Gerolstein

  • Study site

    Gifhorn

  • Study site

    Gütersloh

  • Study site

    Hamburg

  • Study site

    Heilbronn

  • Study site

    Herbolzheim

  • Study site

    Karlsruhe

  • Study site

    Kehl

  • Study site

    Koblenz

  • Study site

    Lauffen am Neckar

  • Study site

    Mannheim

  • Study site

    Marbach

  • Study site

    Mönchengladbach

  • Study site

    München

  • Study site

    Neustadt A.d. Aisch

  • Study site

    Nidderau

  • Study site

    Oberhausen

  • Study site

    Oberkirch

  • Study site

    Offenburg

  • Study site

    Pegnitz

  • Study site

    Rodorf

  • Study site

    Schwäbisch Hall

  • Study site

    Schwieberdingen

  • Study site

    Traunreut

  • Study site

    Veitshöchheim

  • Study site

    Wanzleben

  • Study site

    Welzheim

  • Study site

    Wildeshausen

  • Study site

    Zwiesel

Other trials in Germany

Italy6 sites

  • Study site

    Chiavari

  • Study site

    Ferrara

  • Study site

    Latisana

  • Study site

    Ragusa

  • Study site

    Sassari

  • Study site

    Taranto

Other trials in Italy

About this study

Official title: An Open, Randomised, Comparative, Multicentre Study of the Immunogenicity and Safety of Concomitant Versus Separate Administration of a Combined Measles, Mumps, Rubella and Varicella Live Vaccine (ProQuad®) and a Booster Dose of Infanrix® Hexa in Healthy Children 12 to 23 Months of Age

Primary Objective:

  • To demonstrate that ProQuad® can be administered concomitantly with a booster dose of Infanrix® hexa to healthy children 12 to 23 months of age without impairing either the antibody response rates to measles, mumps, rubella, varicella, hepatitis B and Haemophilus influenzae type b; or to the 3 pertussis antibody titres measured at 42 days following vaccination.
Read more

Secondary Objectives:

  • To describe the antibody titres and the antibody response rates to measles, mumps, rubella, varicella, diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b as measured at 42 days following vaccination by an Infanrix® hexa primary series schedule and all data are pooled.
  • To evaluate the safety profile of ProQuad® when administered concomitantly with a booster dose of Infanrix® hexa by an Infanrix® hexa primary series schedule and all data are pooled.
Being tested
ProQuad®, Infanrix® hexa
Keywords
Mumps and Rubella, Haemophilus influenzae type b (Infanrix® hexa)
Medical subject headings
Chickenpox, Measles, Mumps, Rubella, Diphtheria, Tetanus, Whooping Cough, Poliomyelitis

What participants receive

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

  • ProQuad®Biological

    Participants received a 0.5 mL subcutaneous injection of ProQuad® containing the following live attenuated virus strains: measles virus Enders' Edmonston strain (≥3.00 log10 50% cell culture infectious dose [CCID]50), mumps virus Jeryl Lynn™ (Level B) strain (≥4.30 log10 CCID50), rubella virus Wistar RA 27/3 strain (≥3.00 log10 CCID50), and varicella virus Oka/Merck strain (≥3.99 log10 plaque-forming units [PFU]).

  • Infanrix® hexaBiological

    Participants received a 0.5 mL intramuscular injection of Infanrix® hexa containing the following: diphtheria toxoid (≥30 IU), tetanus toxoid (≥40 IU), 3-component acellular pertussis (pertussis taxoid, filamentous haemagglutinin, and pertactin) (25 ug), Hepatitis B surface antigen recombinant (S protein) (10 ug), inactivated poliovirus types 1-3 (type 1: 40 D-antigen units; type 2: 8 D-antigen units; type 3: 32 D-antigen units), and Haemophilus influenzae type B (Hib) polysaccharide conjugate to tetanus toxoid (20-40 ug).

Study groups in NCT00432042
Study groupRoleWhat they receive
ProQuad® + Infanrix® hexaExperimentalPediatric (12 to 23 months of age) participants received ProQuad® and Infanrix® hexa (booster dose) concomitantly on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
Receives: Biological: ProQuad®; Biological: Infanrix® hexa
ProQuad®Active comparatorPediatric (12 to 23 months of age) participants received ProQuad® on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
Receives: Biological: ProQuad®
Infanrix® hexaActive comparatorPediatric (12 to 23 months of age) participants received Infanrix® hexa (booster dose) on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
Receives: Biological: Infanrix® hexa

What is being measured

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

  1. Percentage of Participants Meeting Antibody Response Rate Criteria to Measles, Mumps, Rubella, and Varicella

    The percentage of participants with seronegative baseline values who met antibody response criteria in Arm 1: ProQuad® + Infanrix® hexa and Arm 2: ProQuad® was determined. Post-vaccination antibody response and baseline seronegativity criteria were as follows: measles antibody titre ≥255 mIU/mL in participants with baseline titre <255 mIU/mL; mumps antibody titre ≥10 ELISA Ab units/mL in participants with baseline titre <10 ELISA Ab units mL; rubella antibody titre ≥10 IU/mL in participants with baseline titre <10 IU/mL; varicella antibody titre ≥5 gpELISA units/mL in participants with baseline titre <1.25 gpELISA units/mL. Measles, mumps and rubella antibody levels were determined using enzyme-linked immunosorbent assay (ELISA) and varicella antibody levels were determined with glycoprotein-based ELISA (gpELISA).

    Measured: Day 42

  2. Percentage of Participants Meeting Post-vaccination Antibody Response Rates to Hepatitis B and Haemophilus Influenzae Type B

    The percentage of participants with seronegative baseline values who met antibody response criteria in Arm 1: ProQuad® + Infanrix® hexa and Arm 3: Infanrix® hexa was determined. Post-vaccination antibody response and baseline seronegativity criteria were as follows: Hepatitis B antibody titre ≥10 IU/mL and Haemophilus Influenzae Type b antibody titre ≥1 ug/mL. Hepatitis B antibody levels were determined using anti-HBs ORTHO ECi Immunodiagnostic Assay. Haemophilus Influenzae Type b antibody (anti-polyribosylribitol phosphate [PRP]) levels were determined with radioimmunoassay (RIA) or with enzyme immunoassay (EIA).

    Measured: Day 42

  3. Post-vaccination Geometric Mean Titres (GMT) to Pertussis

    The GMT to pertussis were compared in Arm1: ProQuad® + Infanrix® hexa and Arm 3: Infanrix® hexa. Anti-pertussis toxin (anti-PT), anti-filamentous hemagglutinin (anti-FHA), and anti-pertactin (anti-PRN) were determined using ELISA on solid phase based on sandwich principle.

    Measured: Day 42

Timeline

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

  1. First posted6 Feb 2007 (estimated)
  2. Study start12 Jan 2007
  3. Primary completion27 Mar 2008
  4. Study completion27 Mar 2008

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
955 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00432042
Sponsor's protocol ID
V221-035
Other IDs
X06-MMRV-302, 2006-004129-27
Status last verified
Feb 2018
First submitted
5 Feb 2007
Last updated
19 Mar 2018
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Deichmann KA, Ferrera G, Tran C, Thomas S, Eymin C, Baudin M. Immunogenicity and safety of a combined measles, mumps, rubella and varicella live vaccine (ProQuad (R)) administered concomitantly with a booster dose of a hexavalent vaccine in 12-23-month-old infants. Vaccine. 2015 May 11;33(20):2379-86. doi: 10.1016/j.vaccine.2015.02.070. Epub 2015 Mar 9.

    PubMed 25765966

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ProQuad® and Infanrix® hexa in people with Varicella and Measles, run by Merck Sharp & Dohme LLC at 50 sites in 2 countries.

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 7 inclusion and 16 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 19 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in Germany, Italy. 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 19 Mar 2018). 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?

Percentage of Participants Meeting Antibody Response Rate Criteria to Measles, Mumps, Rubella, and Varicella (time frame: Day 42). The study lists 3 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 NCT00432042, which also lists 1 linked publication.

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 19 Mar 2018.

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