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.

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2006-004129-27-DE
• Date of registration: 05/10/2006
• Prospective Registration: Yes
• Primary sponsor: Sanofi Pasteur MSD
• Public 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.
• Scientific 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.
• Date of first enrolment: 13/12/2006
• Target sample size: 960
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-004129-27
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Immunogenicity and safety of concomitant versus separate administration of Proquad and Infanrix hexa

Countries of recruitment

Germany, Italy

Key inclusion & exclusion criteria

Inclusion criteria:
1. Healthy subject of either gender,
2. Age from 12 to 23 months [from the 12th month birthday to 1 day prior to the 24th month birthday],
3. Negative clinical history of measles, mumps, rubella, varicella and zoster,
4. 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,
5. Consent form signed by parent(s) according to local regulations or by the legal representative properly informed about the study,
6. Parent(s) / legal representative able to understand the protocol requirements and to fill in the Diary Card.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Prior receipt of measles, mumps, rubella and/or varicella vaccine either alone or in any combination,
2. Any recent (a. continuous household contact, or
b. playmate contact (generally >1 hour of play indoors), or
c. hospital contact (in same 2- to 4-bed room or adjacent beds in a large ward or face-to-face contact with an infectious staff member or subject), or
d. in the case of varicella, contact with a newborn whose mother had onset of varicella 5 days or less before delivery or within 48 hours after delivery,
3. 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,
4. Any recent (or= 38.0°C),
5. Any severe chronic disease,
6. Active untreated tuberculosis,
7. Known personal history of encephalopathy, seizure disorder or progressive, evolving or unstable neurological condition,
8. Any known blood dyscrasia, leukemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic or lymphatic systems,
9. Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection,
10. Prior known sensitivity/allergy to any component of the vaccines including neomycin, sorbitol or gelatin,
11. Any immune impairment or humoral/cellular deficiency, neoplastic disease or depressed immunity including those resulting from corticosteroid [any long-term (>or= 14 days) administration of systemic corticosteroid therapy given daily or on alternate days at high doses (>or= 2 mg/kg/day prednisone equivalent or >or= 20 mg/day if weight more than 10kg) within the previous 30 days] or other immunosuppressive therapy,
12. Any recent (13. Any previous (14. Any recent (15. Any medical condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives,
16. Any recent (


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

The study will involve healthy children.

Intervention(s)

Trade Name: PROQUAD
Product Name: PROQUAD
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: Measles virus Enders'Edmonston Strain (live, attenuated)
Concentration type: not less then
Concentration number: 3.00 log10 CCID50-
INN or Proposed INN: Mumps virus Jeryl lynn (level B) strain (live, attenuated)
Concentration type: not less then
Concentration number: 4.30 log10 CCID50-
INN or Proposed INN: Rubella virus Wistar RA 27/3 strain (live, attenuated)
Concentration type: not less then
Concentration number: 3.00 log10 CCID50-
INN or Proposed INN: Varicella virus Oka/Merck strain (live, attenuated)
Concentration type: not less then
Concentration number: 3.99 log10 PFU-

Trade Name: Infanrix hexa
Product Name: Infanrix hexa
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: Diphtheria toxoid
Concentration unit: IU international unit(s)
Concentration type: not less then
Concentration number: 30-
INN or Proposed INN: Tetanus toxoid
Concentration unit: IU international unit(s)
Concentration type: not less then
Concentration number: 40-
INN or Proposed INN: Pertussis toxoid
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 25-
INN or Proposed INN: Filamentous Haemagglutinin
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 25-
INN or Proposed INN: Pertactin
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 8-
INN or Proposed INN: Hepatitis B surface antigen
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 10-
INN or Proposed INN: Inactivated Type 1 Poliovirus (Mahoney)
Concentration type: equal
Concentration number: 40 D-antigen unit-
INN or Proposed INN: Inactivated Type 2 poliovirus (MEF-1)
Concentration type: equal
Concentration number: 8 D-antigen unit-
INN or Proposed INN: Inactivated Type 3 poliovirus (Saukett)
Concentration type: equal
Concentr

Primary Outcome(s)

Secondary Objective: 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 when administered to healthy children 12 to 23 months of age, by Infanrix® hexa primary series schedule and for all data pooled.

To evaluate the safety profile of ProQuad® when administered concomitantly with a booster dose of Infanrix® hexa to healthy children 12 to 23 months of age, by Infanrix® hexa primary series schedule and for all data pooled.

Main 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 neither the antibody response rates to measles, mumps, rubella, varicella, hepatitis B and Haemophilus influenzae type b, nor the 3 pertussis antibody titres as measured at 42 days following vaccination.

Primary end point(s): The primary immunogenicity criteria are the response rates to measles, mumps, rubella and varicella in Group 1 and Group 2 and to hepatitis B and Haemophilus influenzae type b in Group 1 and Group 3 and the antibody titres to the 3 pertussis antigens in Group 1 and Group 3 as follows:
• The response rate for measles defined as the percentage of subjects with measles antibody titres ³ 255 mIU/mL in subjects whose baseline (BS1) measles antibody titre is < 255 mIU/mL,
• The response rate for mumps defined as the percentage of subjects with mumps antibody titres ³ 10 ELISA Ab units/mL in subjects whose baseline (BS1) mumps antibody titre is < 10 ELISA Ab units/mL,
• The response rate for rubella defined as the percentage of subjects with rubella antibody titres ³ 10 IU/mL in subjects whose baseline (BS1) rubella antibody titre is < 10 IU/mL,
• The response rate for varicella defined as the percentage of subjects with varicella antibody titres ³ 5 gpELISA units/mL in subjects whose baseline (BS1) varicella antibody titre is < 1.25 gpELISA units/mL,
• The response rate for hepatitis B defined as the percentage of subjects with antibody titres (anti-HBs) ³ 10 mIU/mL,
• The response rate for Haemophilus influenzae type b defined as the percentage of subjects with antibody titres (anti-PRP) ³ 1.0 µg/mL.
• The post-vaccination GMT to pertussis (anti-PT, anti-FHA and anti-PRN),

Secondary ID(s)

X06-MMRV-302