Phase 3
N=716
Immunogenicity and Safety Study of PriorixTetra™ When Co-administered With Conjugated MenC Vaccine in Healthy Children
Rubella · Varicella · Measles · Mumps
Bottom Line
View on ClinicalTrials.gov: NCT01506193 ↗Enrolled (actual)
716
Serious AEs
1.7%
Results posted
Jan 2017
Primary outcome: Primary: Number of Seroconverted Subjects for Measles, Mumps, Rubella, and Varicella Virus — 305; 162; 292; 151 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- PriorixTetra™ (Biological); Meningitec (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Feb 2014
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 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 | — |
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.
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). 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.