To describe the safety profile of a second dose of ProQuad® manufactured with rHA when administered to children in their second year of life.
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary safety criteria will describe the safety profile of a second dose
of ProQuad® manufactured with rHA when administered to children in their second
year of life.
Secondary outcome
The secondary safety criteria will describe the safety profile of a first dose
of ProQuad® manufactured with rHA when administered to children in their second
year of life.
Background summary
ProQuad® is manufactured here with rHA instead of HSA in order to avoid
possible consequences caused by the use of human blood products.
Study objective
To describe the safety profile of a second dose of ProQuad® manufactured with
rHA when administered to children in their second year of life.
Study design
This is a phase 3B, multicenter research, designed to investigate the safety of
the administration of 2 BMR-W injections to children in the 2nd year of their
life.
(Visit 0 : review the informed consent and administration of MenC injection)
Visit 1 (at least 14 days after visit 0) : completion/verifying of informed
consent (in case there has not been a visit 0)
Verifying the medical history. The first subcutaneous injection is given in the
upper arm. The child is observed after the injection during 20 minutes for
possible (S)AE*s. The parents have to keep a diary at home with in it the
temperature measurements and the possible adverse events experienced by their
child.
Visit 2 (28 to 42 days after visit 1) : The diary is evaluated by the study
doctor. The second injection will be a subcutaneous injection (in the other
arm) in the upper arm. The child is observed after the injection during 20
minutes for possible (S)AE*s. The parents have to keep a diary with in it the
temperature measurements and the possible adverse events experienced by their
child.
Visit 3 (28 to 42 days after visit 2) : The diary is evaluated by the study
doctor. (in case there was no visit 0, the MenC injection will now be given).
At each visit the child will be physically examined by the study doctor.
Between injection 1 and 2 there will be checked by means of the temporary or
permanent contra indications if the child can continue to participate in the
study or that the second injection will be given later.
Intervention
Two doses of ProQuad® manufactured with rHA.
Both doses will be given under the skin in the upper arm and the second dose
will be given in the contra lateral arm (if the first dose is injected in the
right upper arm, the second dose will be injected in the left upper arm and
vice versa).
Study burden and risks
The child will participate in this study in total at least 56 days, at the most
84 days. The child will be given 2 subcutaneous injections. The parents have to
keep a diary between the visits with the temperature measurements and the
possible (S)AE*s.
Some very common adverse events are observed in around 1 case in 10 after
ProQuad® vaccination. These adverse events are fever >= 38.9°C (oral
temperature), erythema/ redness and pain/ soreness/ tenderness at the injection
site.
Some other less frequent vaccine related adverse events occur in around 1 case
for 100 after ProQuad® vaccination such as upper respiratory infection,
diarrhoea, vomiting, irritability, rashes and local reactions at the injection
site such as ecchymosis or swelling.
As with any vaccination, there is a rare possibility of an allergic reaction.
This may cause a severe narrowing of the air passages and breathing
difficulties. This is the reason why your study doctor will keep your child
under close medical surveillance for 20 minutes after vaccination to allow
immediate medical care.
8, Rue Jonas Salk
69367 Lyon Cedex
Frankrijk
8, Rue Jonas Salk
69367 Lyon Cedex
Frankrijk
Listed location countries
Age
Inclusion criteria
1. Healthy subject of either gender
2. Age from 12 to 22 months (from the 12 month birthday to one day prior to the 23rd month birthday),
3. Negative clinical history of infection with measles, mumps, rubella, varicella or zoster,
4. Informed consent form signed by the parent(s) or by legal representative according to the local regulations
5. Parent(s) or legal representative able to attend all scheduled visits with the subject and to understand and comply with the study procedures (i.e. able to read and write).
Exclusion criteria
1. Recent (<= 3 days) history of febrile illness(defined as rectal temperature >= 38.0°C)
2. Prior receipt of measles, mumps, rubella and/or varicella vaccination, either alone or in any combination
3. Recent (<= 30 days) exposure to measles, mumps, rubella, varicella or zoster involving:
• continuous household contact, or,
• playmate contact (generally >1 hour of play indoors), or
• 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
• contact with a newborn whose mother had onset of varicella 5 days or less before delivery or within 48 hours after delivery,
4. Prior known sensitivity/allergy to any component of the vaccine including neomycin, sorbitol or gelatin, or true allergy to egg proteins (anaphylactic or anaphylactoid reaction after ingesting eggs)
5. Severe chronic disease,
6. Blood dyscrasias, leukaemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic and lymphatic system
7. Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection
8. Humoral or cellular (primary or acquired) immunodeficiency, including hypogammaglobulinemia and dysgammaglobulinemia and AIDS, or symptomatic HIV infection
9. Current immunosuppressive therapy (including systemic corticosteroids given daily or on alternate days at >=20 mg/day prednisone equivalent during >=14 days within the past 30 days)
10. Family history of congenital or hereditary immunodeficiency
11. Hereditary problems of fructose intolerance
12. Known personal history of encephalopathy, seizure disorder or progressive, evolving or unstable neurological condition,
13. Known active tuberculosis
14. Recent (<= 2 days) tuberculin test or scheduled tuberculin test through Visit 3
15. Receipt of immunoglobulins or blood-derived products in the past 150 days
16. Receipt of an inactivated vaccine in the past 14 days
17. Receipt of a live vaccine in the past 28 days
18. Any medical condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
19. Participation to another clinical study in the past 30 day.;There are also a list of temporary contra-indications and a list of defenitive contra-indications to further vaccination. See protocol page 20 for the detailed list.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-002438-12-NL |
| CCMO | NL18473.000.07 |