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Phase 2 N=1,220 Randomized Triple-blind Prevention

Immunogenicity of GSKs' MMR Vaccine (209762) vs. M-M-R® II, When Given With Routine Vaccines at 12-15 Months of Age

Rubella · Mumps · Measles · Measles-Mumps-Rubella Vaccine

Enrolled (actual)
1,220
Serious AEs
2.1%
Results posted
Nov 2011
Primary outcome: Primary: Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value. — 245; 236; 236; 248 Subjects

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
GSK Biological's investigational vaccine 209762 (Biological); M-M-R® II (Merck and Co) (Biological); Varivax® (Biological); Havrix® (Biological); Prevnar® (Biological)
Age
Pediatric · 0+ yrs
Sex
All
Sponsor
GlaxoSmithKline
Primary completion
Jul 2010

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value.
245; 236; 236; 248
PRIMARY
Number of Subjects With Anti-mumps Virus Antibody Titer Equal to or Above the Cut-off-value.
175; 183; 175; 175
PRIMARY
Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value.
171; 158; 168; 166
SECONDARY
Number of Subjects With Anti-varicella Antibody Concentration Equal to or Above the Cut-off-value.
240; 230; 230; 241
SECONDARY
Anti-measles Virus Antibody Concentrations
3224.3; 3708.2; 3534.7; 3828.1
SECONDARY
Anti-mumps Virus Antibody Concentrations
242.0; 265.0; 253.4; 267.6
SECONDARY
Anti-rubella Virus Antibody Concentrations
78.0; 79.5; 81.7; 93.1
SECONDARY
Anti-S. Pneumoniae Antibody Concentrations (by Serotype).
0.54; 0.61; 0.67; 0.67; 0.53; 0.57
SECONDARY
Anti-varicella Antibody Concentrations.
245.5; 235.2; 236.0; 255.9
SECONDARY
Anti-hepatitis A Virus Antibody Concentrations.
33.8; 39.2; 39.4; 42.1
SECONDARY
Number of Subjects With Anti-hepatitis A Antibody Concentrations Equal to or Above the Cut-off-value.
98; 99; 94; 110
SECONDARY
Anti-S. Pneumoniae Antibody Concentrations (by Serotype).
0.54; 0.61; 0.67; 0.67; 0.53; 0.57
SECONDARY
Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value
171; 159; 168; 166
SECONDARY
Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value
171; 159; 168; 166
SECONDARY
Anti-measles Virus Antibody Concentrations
3224.3; 3708.2; 3534.7; 3828.1
SECONDARY
Anti-measles Virus Antibody Concentrations
3224.3; 3708.2; 3534.7; 3828.1
SECONDARY
Number of Subjects Reporting Investigator-confirmed Measles/Rubella-like Rash and Varicella-like Rash.
0; 4; 0; 0; 6; 7
SECONDARY
Number of Subjects Reporting Febrile Convulsions
0; 1; 0; 1
SECONDARY
Anti-mumps Virus Antibody Titers (Enhanced Plaque Reduction Neutralization (PRN))
162.8; 188.3; 176.2; 185.5
SECONDARY
Number of Subjects Reporting Other Rash.
72; 74; 60; 60; 26; 29
SECONDARY
Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Enhanced PRN)
169; 170; 171; 170
SECONDARY
Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value.
171; 158; 168; 166
SECONDARY
Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value.
171; 158; 168; 166
SECONDARY
Anti-rubella Virus Antibody Concentrations
78.0; 79.5; 81.7; 93.1
SECONDARY
Anti-rubella Virus Antibody Concentrations
78.0; 79.5; 81.7; 93.1
SECONDARY
Number of Subjects Reporting Fever.
65; 79; 64; 56; 10; 7
SECONDARY
Number of Subjects With Solicited Local Symptoms.
70; 70; 79; 67; 45; 47
SECONDARY
Number of Subjects Reporting Medically Attended Visit (MAEs)
99; 99; 97; 107
SECONDARY
Number of Subjects With Unsolicited Adverse Events (AEs).
170; 153; 164; 169
SECONDARY
Number of Subjects Reporting Investigator-confirmed Parotid/Salivary Gland Swelling.
3; 3; 5; 2
SECONDARY
Number of Subjects With Solicited General Symptoms.
133; 106; 113; 109; 180; 141
SECONDARY
Number of Subjects Reporting New Onset Chronic Illnesses (NOCIs).
5; 2; 4; 2
SECONDARY
Number of Subjects Reporting Serious Adverse Events (SAEs)
1; 6; 7; 9
SECONDARY
Number of Subjects Reporting Serious Adverse Events (SAEs).
0; 0; 0; 1
SECONDARY
Number of Subjects Reporting Conditions Prompting Emergency Room (ER) Visits.
27; 28; 22; 26
SECONDARY
Anti-mumps Virus Antibody Titers (Unenhanced PRN)
43.4; 48.9; 57.4; 60.7
SECONDARY
Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Unenhanced PRN)
144; 134; 152; 144
SECONDARY
Anti-mumps Virus Antibody Titers (Unenhanced PRN)
43.4; 48.9; 57.4; 60.7
SECONDARY
Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Unenhanced PRN)
144; 134; 152; 144
SECONDARY
Anti-mumps Virus Antibody Concentrations (Pharmaceutical Product Development (PPD) ELISA)
47.3; 42.9; 42.5; 58.6
SECONDARY
Number of Subjects With Anti-mumps Virus Antibody Concentrations Above the Cut-off Value (PPD ELISA)
128; 125; 136; 134
SECONDARY
Anti-mumps Virus Antibody Concentrations (PPD ELISA)
47.8; 50.2; 54.0; 59.2
SECONDARY
Number of Subjects With Anti-mumps Virus Antibody Concentrations Above the Cut-off Value (PPD ELISA)
128; 125; 136; 134

Summary

The purpose of this study is to compare two measles, mumps and rubella conjugate vaccines (manufactured by GSK and Merck and Company ) in terms of the immune response elicited and safety with a six month follow-up after first vaccination. Additionally, antibody persistence will be assessed one and two years after administration of MMR vaccine. The Protocol Posting has been updated following Protocol amendment 1 and 2, Oct 2009.

Eligibility Criteria

Inclusion Criteria

  • Subjects for whom the investigator believes their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
  • Male or female between 12 and 15 months of age (e.g. from age 12 months until the day before age 16 months) at the time of vaccination.
  • Written informed consent obtained from the parent/guardian of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Have previously received three doses of 7-valent pneumococcal conjugate vaccine within the first year of life with the third dose administered at least 30 days prior to enrolment and vaccination with study vaccines.

Exclusion Criteria

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • 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 (pharmaceutical product or device).
  • Chronic administration (defined as more than 14 days) 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 from 30 days prior to vaccination until 42 days after vaccination, except for influenza vaccine and Hib vaccine.
  • Previous vaccination against measles, mumps, rubella and/or varicella.
  • Previous vaccination against hepatitis A or receipt of a fourth dose of pneumococcal conjugate vaccine.
  • History of measles, mumps, rubella, varicella/zoster and hepatitis A diseases.
  • Known exposure to measles, mumps, rubella and/or varicella/zoster within 30 days prior to the start of the study.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required), including human immunodeficiency virus (HIV) infection.
  • A family history of congenital or hereditary immunodeficiency.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
  • Hypersensitivity to latex
  • Major congenital defects or serious chronic illness.
  • History of any neurologic disorders or seizures, including febrile seizures.
  • Acute disease at the time of enrolment.
  • Administration of polyclonal immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00861744). 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.

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