Measles-Mumps-Rubella Clinical Trial
Official title:
A Phase III, Multi-Center, Randomized, Observer-Blind, Active Controlled Non-Inferiority Study to Evaluate the Immunogenicity and Safety of SIBP's MMR Vaccine Compared to GSK MMR Vaccine in Children, 9-11 Months of Age
To evaluate the Immunogenicity and Safety of Shanghai Institute of Biological Products Co., Ltd.'s Measles, Mumps and Rubella (MMR) Vaccine Compared to a Licensed and WHO Prequalified GSK MMR Vaccine in Healthy African Children, 9-11 Months of Age.
| Status | Not yet recruiting |
| Enrollment | 1200 |
| Est. completion date | June 20, 2025 |
| Est. primary completion date | June 20, 2025 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 9 Months to 11 Months |
| Eligibility | Inclusion Criteria: - Healthy male and female child as established by medical history and clinical examination at enrollment. - Age: 9-11 months (inclusive) at the time of enrollment - Parent's/legally acceptable representative's (LAR) ability to read and willingness to provide written informed consent as per the ethical and regulatory requirements of the site. - Parent confirms intention to stay in the study area for the study duration, bring their child in for the required study visits or to accept a home visit by the study staff. Exclusion Criteria: - Presence of fever (defined as axillary temperature = 37.5°C) (temporary exclusion until recovery) - Acute disease of moderate to severe intensity at the time of enrollment (temporary exclusion until recovery) - Use of antipyretics within the last 72 hours prior to enrolment (temporary exclusion until recovery) - Prior (within 6 months) or concurrent participation in another interventional clinical trial during the study - Presence of severe malnutrition (weight-for-height z-score < -3SD median) - Positive test for any of the following: HIV, hepatitis B, hepatitis C and syphilis - Presence of any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological (including severe anemia), endocrine, immunological, dermatological, neurological, cancer, or autoimmune disease) as determined by medical history and / or physical examination which would compromise the participant's health or is likely to result in nonconformance to the protocol. - Known or suspected impairment of immunological function based on medical history and physical examination. - Prior receipt or intent to receive measles, mumps, rubella, or yellow fever-containing vaccine during the study vaccination and follow up period up to Day 85 outside the study center. - Receipt of any vaccine (except OPV and inactivated influenza) within 4 weeks of the day of study vaccination or intent to receive any within 6 weeks after study vaccination. - Receipt of immunoglobulin therapy and / or blood products in the past 9 months or planned administration during the study period - Receipt of any immune-modifying or immunosuppressant drugs prior to the first study vaccine dose or planned use during the study. A chronic oral or parenteral use (defined as more than 14 days) of high dose corticosteroids (defined as =2 mg/kg of body weight or =20 mg/day of prednisone or equivalent for persons who weigh >10 kg) will be exclusionary for the study. Children on inhaled or topical steroids may be permitted to participate in the study. - Evidence of a clinically significant major congenital anomaly or genetic defect as judged by the investigator. - Any known or suspected bleeding disorder in the participant that would pose a risk to venipuncture or intramuscular injection. - History of any neurologic disorders including encephalopathy, epilepsy, and other progressive neurological diseases - A known or suspected sensitivity or allergy to any components of the investigational product including egg, chicken protein and the antibiotic gentamycin. - History of severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis. - Any medical condition in the parent/LAR or child which, in the judgment of the Investigator, would interfere with or serves as a contraindication to protocol adherence or a participant's parent(s)'/LAR's ability to give informed consent. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Shanghai Institute Of Biological Products | Victoria Biomedical Research Institute |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Difference of seropositivity rate | An evaluation of seropositivity rate to Measles, Mumps and Rubella viruses of SIBP MMR vaccine versus GSK MMR vaccine when measured 42 days after vaccination in seronegative children at baseline. | 42 days | |
| Secondary | The percentage of immediate adverse events (AEs) | The percentage of any adverse events in subjects within 30 minutes after each vaccination. | 30 minutes | |
| Secondary | The percentage of solicited local reactogenicity | The percentage of solicited local reactogenicity in subjects through 7 days after each vaccination. | 7 days | |
| Secondary | The percentage of solicited systemic reactogenicity | The percentage of solicited systemic reactogenicity in subjects through 14 days after each vaccination. | 14 days | |
| Secondary | The percentage of unsolicited AEs | The percentage of unsolicited AEs in subjects through 42 days after each vaccination. | 42 days | |
| Secondary | The percentage of serious adverse events (SAEs) | The percentage of SAEs reported up to 42 days and up to 6 months after first vaccination. | 42 days | |
| Secondary | Geometric mean titer (GMT) of Yellow Fever | Geometric mean titer (GMT) for anti-yellow fever virus neutralizing antibodies at baseline and 42 days after vaccination. | 42 days | |
| Secondary | Geometric mean concentration (GMC) of Measles | Geometric mean concentration (GMC) for anti-measles IgG antibodies at baseline and 42 days after vaccination. | 42 days | |
| Secondary | Geometric mean concentration (GMC) of Mumps | Geometric mean concentration (GMC) for anti-mumps IgG antibodies at baseline and 42 days after vaccination. | 42 days | |
| Secondary | Geometric mean concentration (GMC) of Rubella | Geometric mean concentration (GMC) for anti-rubella IgG antibodies at baseline and 42 days after vaccination. | 42 days | |
| Secondary | Seropositivity rate of Measles | Seropositivity rate for measles antigen as measured by antibody titers at baseline and 42 days after vaccination. | 42 days | |
| Secondary | Seropositivity rate of Mumps | Seropositivity rate for mumps antigen as measured by antibody titers at baseline and 42 days after vaccination. | 42 days | |
| Secondary | Seropositivity rate of Rubella | Seropositivity rate for rubella antigen as measured by antibody titers at baseline and 42 days after vaccination. | 42 days |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01621802 -
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Subjects Four to Six Years of Age
|
Phase 3 |