Phase 3
Completed N=716
Immunogenicity and Safety Study of PriorixTetra™ When Co-administered With Conjugated MenC Vaccine in Healthy Children
Source: ClinicalTrials.gov NCT01506193 ↗Enrolled (actual)
716
Serious AEs
1.7%
Results posted
Jan 2017
Primary outcomePrimary: Number of Seroconverted Subjects for Measles, Mumps, Rubella, and Varicella Virus — 305; 162; 292; 151 Participants
◆ Published Evidence
Emerging
10citations · ~1 / year
The immunogenicity and safety of a tetravalent measles-mumps-rubella-varicella vaccine when co-administered with conjugated meningococcal C vaccine to healthy children: A phase IIIb, randomized, multi-center study in Italy.
Summary
The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals' investigational measles, mumps, rubella and varicella (MMRV) vaccine (GSK208136, PriorixTetra™) when co-administered along with conjugated Meningococcal C (MenC) vaccine (Meningitec®, Nuron Biotechs' Vaccine) in healthy children.
Linked Publications
-
The immunogenicity and safety of a tetravalent measles-mumps-rubella-varicella vaccine when co-administered with conjugated meningococcal C vaccine to healthy children: A phase IIIb, randomized, multi-center study in Italy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Seroconverted Subjects for Measles, Mumps, Rubella, and Varicella Virus |
305; 162; 292; 151; 309; 164 | — |
| PRIMARY Number of Seroprotected Subjects for rSBA-MenC Antibodies |
286; 142 | — |
| SECONDARY Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms |
79; 4; 78; 31; 1; 1 | — |
| SECONDARY Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms |
3; 4; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects Reporting Fever Per Half Degree |
159; 86; 46; 15; 9; 4 | — |
| SECONDARY Number of Subjects Reporting Any, Localised and Generalised Rashes |
91; 41; 15; 59; 30; 2 | — |
| SECONDARY Number of Subjects With Any Unsolicited Adverse Events (AEs) |
97; 61; 41 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
6; 4; 2 | — |
| SECONDARY Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses |
2943.6; 3158.5; 1530.7; 1591.3; 40.2; 44.9 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who the investigator believes that parent(s)/Legally Acceptable Representatives (LAR) can and will comply with the requirements of the protocol.
- A male or female between, and including, 13 and 15 months of age at the time of the first vaccination.
- Written informed consent obtained from the parent(s)/ LAR of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion Criteria
- Child in care.
- Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Planned administration/ administration of a vaccine not foreseen by the study protocol starting 30 days prior to the study vaccination/s and ending 42 days after the vaccination/s (at Visit 2), with the exception of inactivated influenza (flu) vaccine, which may be given at any time during the study, including the day of study vaccination/s.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
- Previous vaccination against measles, mumps, rubella, varicella/ herpes zoster and/or N. meningitidis serogroup C.
- History of measles, mumps, rubella, varicella and/or N. meningitidis serogroup C diseases.
- Known exposure to measles, mumps, rubella and or varicella starting 30 days prior to enrolment.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Family history of congenital or hereditary immunodeficiency.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
- Major congenital defects or serious chronic illness.
- Acute disease and/or fever at the time of enrollment.
- Documented human immunodeficiency virus (HIV) positive subject.
- Any contraindications as stated in the Summary of Product Characteristics.
- Administration of immunoglobulins and/or any blood products within three months prior to the first vaccine dose or planned administration during the study period.
Data sourced from ClinicalTrials.gov (NCT01506193) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.