An open-label, randomised, comparative, multi-centre study of the immunogenicity and safety of the concomitant use of a live pentavalent rotavirus vaccine (RotaTeq®) and a meningococcal group C conjugate (MCC) vaccine in healthy infants
- Conditions
- RotaTeq® is indicated for the active immunisation of infants from age of 6 weeks for prevention of gastroenteritis due to rotavirus infection.NeisVac-C® is indicated for active immunisation of children from 2 months of age for the prevention of invasive disease caused by Neisseria meningitidis serogroup C
- Registration Number
- EUCTR2006-005445-11-FI
- Lead Sponsor
- Sanofi Pasteur MSD S.N.C.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Healthy infants, aged from 6 weeks through full 7 weeks (= 42 to < 56 days; 6th week birthday to one day prior to the 8th week birthday),
2. Consent form signed by at least one parent or by the legal representative properly informed about the study,
3. 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
1. History of congenital abdominal disorders, congenital malformation of the gastrointestinal tract that could predispose to intussusception, or abdominal surgery,
2. Congenital fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency,
3. Known or suspected impairment of immunological function,
4. Known hypersensitivity to any component of RotaTeq® (e.g. sucrose) or of NeisVac-C® (including tetanus toxoid),
5. Prior administration of any rotavirus vaccine,
6. Prior administration of any vaccine within the 28 days prior to randomisation,
7. Fever (rectal temperature =38.1°C) and/or acute diarrhoea and/or vomiting at randomisation,
8. History of known prior rotavirus gastroenteritis, chronic diarrhoea, or failure to thrive,
9. Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection,
10. Clinical evidence of active gastrointestinal illness. Note: Infants with gastroesophageal reflux disease may participate in the study as long as the gastroesophageal reflux disease is well controlled with or without medication,
11. Receipt of intramuscular, oral, or intravenous corticosteroid treatment within the 14 days prior to randomisation. Note: Infants on inhaled and/or topical steroids may participate in the study,
12. Infants residing in a household with an immunocompromised person, including individuals with congenital immunodeficiency, human immunodeficiency virus (HIV) infection, leukemia, lymphoma, Hodgkin’s disease, multiple myeloma, generalised malignancy, chronic renal failure, meningitis, organ or bone marrow transplantation, or with those receiving anti-cancer drugs or immunosuppressive chemotherapy, including long-term systemic corticosteroids,
13. Prior receipt of a blood transfusion or blood products, including immunoglobulins,
14. Participation in another clinical study before or during the current clinical study,
15. Any infant who cannot be adequately followed for safety by a contact visit,
16. Any condition that, in the opinion of the investigator, may interfere with the evaluation of the study objectives.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate that RotaTeq® can be administered concomitantly with MCC vaccine to healthy infants without impairing the antibody seroprotection rate to meningococcal Group C serotype as measured by serum bactericidal antibody with rabbit complement (rSBA) at 28 days following the last dose.;Secondary Objective: 1. To describe the immunogenicity of RotaTeq® and of the MCC vaccine when administered concomitantly with RotaTeq®.<br><br>2. To describe the safety profile of RotaTeq® and of the MCC vaccine when administered concomitantly with RotaTeq®.<br>;Primary end point(s): Men C seroprotection rate (i.e. the proportion of subjects who achieve a Men C-rSBA titre >= 1:8) as measured 28 days following the 2nd MCC vaccine dose, in the concomitant administration group is non-inferior to that in the separate administration group.
- Secondary Outcome Measures
Name Time Method